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Prostate Cancer
61 papersPrevention3
Effect of dutasteride on the risk of prostate cancer
Conclusion: In men aged 50–75 at increased risk (PSA 2.5–10.0 ng/mL and one prior negative biopsy), 4 years of dutasteride reduced biopsy-detected prostate cancer versus placebo (relative risk reduction 22.8%) and improved BPH-related outcomes.
REDUCE, New England Journal of Medicine, Published Apr 2010Read on PubMedEffect of selenium and vitamin E on risk of prostate cancer and other cancers: the Selenium and Vitamin E Cancer Prevention Trial (SELECT)
Conclusion: In 35,533 relatively healthy men, selenium, vitamin E, or both did not prevent prostate cancer versus placebo (vitamin E HR 1.13; selenium HR 1.04), with no significant differences in any other prespecified cancer end point.
SELECT, JAMA, Published Jan 2009Read on PubMedThe influence of finasteride on the development of prostate cancer
Conclusion: In men aged 55 or older with normal DRE and PSA ≤3.0 ng/mL, 7 years of finasteride reduced prostate cancer prevalence by 24.8% versus placebo, but increased high-grade (Gleason 7–10) tumors and sexual side effects.
PCPT, New England Journal of Medicine, Published Jul 2003Read on PubMedScreening4
Effect of a Low-Intensity PSA-Based Screening Intervention on Prostate Cancer Mortality: The CAP Randomized Clinical Trial
Conclusion: In a UK cluster-randomized trial of men aged 50–69, a single invitation for PSA testing did not significantly reduce prostate cancer mortality versus unscreened standard practice at a median 10 years (RR 0.96) but increased low-risk cancer detection.
CAP, JAMA, Published Mar 2018Read on PubMedMortality results from the Göteborg randomised population-based prostate-cancer screening trial
Conclusion: In 20,000 men from the Swedish population register randomized to biennial PSA screening invitation or no invitation, screening reduced prostate cancer mortality almost by half over 14 years (rate ratio 0.56), though the risk of overdiagnosis was substantial.
Göteborg, The Lancet Oncology, Published Aug 2010Read on PubMedMortality results from a randomized prostate-cancer screening trial
Conclusion: In 76,693 US men, annual PSA and DRE screening versus usual care increased prostate cancer incidence (rate ratio 1.22) but did not significantly reduce prostate cancer mortality after 7 to 10 years (rate ratio 1.13).
PLCO, New England Journal of Medicine, Published Mar 2009Read on PubMedScreening and prostate-cancer mortality in a randomized European study
Conclusion: In 162,243 European men aged 55–69, PSA screening about every 4 years reduced prostate cancer mortality by 20% versus no screening (rate ratio 0.80) at a median 9 years, but with a high risk of overdiagnosis.
ERSPC, New England Journal of Medicine, Published Mar 2009Read on PubMedDiagnosis & Evaluation8
Results after Four Years of Screening for Prostate Cancer with PSA and MRI
Conclusion: Over a median 3.9 years of PSA-plus-MRI screening, omitting biopsy after negative MRI (MRI-targeted biopsy only) versus systematic biopsy more than halved detection of clinically insignificant cancer (RR 0.43), and the risk of incurable cancer at screening or as interval cancer was very low.
Göteborg-2, New England Journal of Medicine, Published Sep 2024Read on PubMedProstate Cancer Screening with PSA and MRI Followed by Targeted Biopsy Only
Conclusion: In population-based PSA screening of men aged 50 to 60 years, MRI-targeted biopsy alone (versus systematic plus targeted biopsy) halved diagnosis of clinically insignificant cancer (RR 0.46) at the cost of delayed detection of intermediate-risk tumors in a small proportion of men.
Göteborg-2, New England Journal of Medicine, Published Dec 2022Read on PubMedMRI-Targeted or Standard Biopsy in Prostate Cancer Screening
Conclusion: In population-based screening of men aged 50–74 with PSA ≥3 ng/mL, MRI with targeted and standard biopsy if suggestive of cancer was noninferior to standard biopsy for clinically significant cancer (21% vs 18%) and detected less clinically insignificant cancer (4% vs 12%).
STHLM3-MRI, New England Journal of Medicine, Published Sep 2021Read on PubMedProstate-specific membrane antigen PET-CT in patients with high-risk prostate cancer before curative-intent surgery or radiotherapy (proPSMA): a prospective, randomised, multicentre study
Conclusion: In men with high-risk localized prostate cancer, PSMA PET-CT had 27% greater accuracy than conventional CT and bone scanning (92% vs 65%) for detecting pelvic nodal or distant metastases, making it a suitable replacement for conventional imaging.
proPSMA, The Lancet, Published Apr 2020Read on PubMedActive Surveillance Magnetic Resonance Imaging Study (ASIST): Results of a Randomized Multicenter Prospective Trial
Conclusion: In men with recently diagnosed grade group 1 cancer needing confirmatory biopsy, adding MRI-targeted to systematic biopsy did not significantly increase upgrading to GG ≥2 versus 12-core systematic biopsy alone (33% vs 27%); targeted biopsies identified most, but not all, clinically significant cancers.
ASIST, European Urology, Published Feb 2019Read on PubMedUse of prostate systematic and targeted biopsy on the basis of multiparametric MRI in biopsy-naive patients (MRI-FIRST): a prospective, multicentre, paired diagnostic study
Conclusion: In biopsy-naive men, systematic and MRI-targeted biopsy did not differ significantly in detecting ISUP grade group ≥2 cancer (29.9% vs 32.3%), but combining both improved detection; prebiopsy MRI can improve detection but does not seem to avoid the need for systematic biopsy.
MRI-FIRST, The Lancet Oncology, Published Jan 2019Read on PubMedMRI-Targeted or Standard Biopsy for Prostate-Cancer Diagnosis
Conclusion: In biopsy-naive men with suspected prostate cancer, MRI with targeted biopsy (no biopsy if MRI was nonsuspicious) was superior to standard TRUS biopsy, detecting more clinically significant cancer (38% vs 26%) and less clinically insignificant cancer; 28% avoided biopsy.
PRECISION, New England Journal of Medicine, Published May 2018Read on PubMedDiagnostic accuracy of multi-parametric MRI and TRUS biopsy in prostate cancer (PROMIS): a paired validating confirmatory study
Conclusion: In biopsy-naive men with PSA up to 15 ng/mL, multiparametric MRI was more sensitive (93% vs 48%) but less specific than TRUS biopsy for clinically significant cancer against template mapping biopsy; as a triage test it might let 27% avoid primary biopsy.
PROMIS, The Lancet, Published Feb 2017Read on PubMedPSA & Other Markers4
Use of the percentage of free prostate-specific antigen to enhance differentiation of prostate cancer from benign prostatic disease: a prospective multicenter clinical trial
Conclusion: In men with PSA 4.0 to 10.0 ng/mL and a palpably benign prostate, a percent free PSA cutoff of 25% or less detected 95% of cancers while avoiding 20% of unnecessary biopsies, and is recommended regardless of age or prostate size.
Catalona et al., JAMA, Published May 1998Read on PubMedComparison of digital rectal examination and serum prostate specific antigen in the early detection of prostate cancer: results of a multicenter clinical trial of 6,630 men
Conclusion: In 6,630 men aged 50 or older screened at 6 centers, PSA detected significantly more cancers than DRE (82% vs 55%), and combining PSA with DRE enhanced early detection, supporting biopsy if either PSA >4 micrograms/L or DRE is suspicious.
Catalona et al., The Journal of Urology, Published May 1994Read on PubMedMeasurement of prostate-specific antigen in serum as a screening test for prostate cancer
Conclusion: In 1653 healthy men aged 50 or older, serum PSA had the lowest error rate of the single tests, and PSA plus rectal examination (with ultrasonography for abnormal findings) detected prostate cancer better than rectal examination alone.
Catalona et al., New England Journal of Medicine, Published Apr 1991Read on PubMedProstate-specific antigen as a serum marker for adenocarcinoma of the prostate
Conclusion: In 699 patients (378 with prostate cancer), serum PSA was more sensitive than prostatic acid phosphatase for detecting prostate cancer and likely more useful for monitoring response and recurrence after therapy, but neither marker was specific because both may be elevated in BPH.
Stamey et al., New England Journal of Medicine, Published Oct 1987Read on PubMedProstate Biopsy2
Antibiotic prophylaxis for transrectal prostate biopsy
Conclusion: Across 19 randomized trial reports (3599 patients) of transrectal prostate biopsy, antibiotic prophylaxis versus placebo/no treatment effectively prevented infectious complications, including hospitalization (RR 0.13), with no definitive evidence that 3-day or multiple-dose courses beat 1-day or single-dose regimens.
Cochrane review, Cochrane Database of Systematic Reviews, Published May 2011Read on PubMedIncreasing hospital admission rates for urological complications after transrectal ultrasound guided prostate biopsy
Conclusion: In 75,190 Ontario men undergoing TRUS-guided prostate biopsy (1996 to 2005), 30-day hospital admission rates for urological complications rose from 1.0% to 4.1%, driven mainly by infection-related complications, while 30-day mortality (0.09%) did not change.
Nam et al., The Journal of Urology, Published Mar 2010Read on PubMedObservation vs Treatment3
10-Year Outcomes after Monitoring, Surgery, or Radiotherapy for Localized Prostate Cancer
Conclusion: In 1643 men with PSA-detected localized prostate cancer randomized to active monitoring, radical prostatectomy, or radiotherapy, prostate-cancer mortality at a median 10 years was low with no significant difference among groups, while surgery and radiotherapy had lower rates of progression and metastases.
ProtecT, New England Journal of Medicine, Published Oct 2016Read on PubMedRadical prostatectomy or watchful waiting in early prostate cancer
Conclusion: During 23.2 years of follow-up of 695 men with early prostate cancer, radical prostatectomy versus watchful waiting substantially reduced mortality, including prostate-cancer death (RR 0.56), with the largest benefit in men younger than 65 years and those with intermediate-risk disease.
SPCG-4, New England Journal of Medicine, Published Mar 2014Read on PubMedRadical prostatectomy versus observation for localized prostate cancer
Conclusion: In 731 men with localized prostate cancer detected in the early PSA era, radical prostatectomy did not significantly reduce all-cause mortality (HR 0.88) or prostate-cancer mortality versus observation through at least 12 years, with absolute differences under 3 percentage points.
PIVOT, New England Journal of Medicine, Published Jul 2012Read on PubMedRadiation & ADT6
Combined androgen deprivation therapy and radiation therapy for locally advanced prostate cancer: a randomised, phase 3 trial
Conclusion: In locally advanced (T3-4 or high-risk T2) prostate cancer, adding RT to lifelong ADT improved 7-year OS versus ADT alone (74% vs 66%; HR 0.77), with only a small effect on late gastrointestinal toxicity.
PR3/PR07, The Lancet, Published Dec 2011Read on PubMedDuration of androgen suppression in the treatment of prostate cancer
Conclusion: In locally advanced prostate cancer, RT plus 6 months of androgen suppression gave inferior survival versus RT plus 3 years of suppression (5-year overall mortality 19.0% vs 15.2%; HR 1.42), so short-term suppression failed to show noninferiority.
EORTC 22961, New England Journal of Medicine, Published Jun 2009Read on PubMedEndocrine treatment, with or without radiotherapy, in locally advanced prostate cancer (SPCG-7/SFUO-3): an open randomised phase III trial
Conclusion: In locally advanced or high-risk local prostate cancer, adding RT to endocrine therapy halved 10-year prostate-cancer-specific mortality versus endocrine therapy alone (11.9% vs 23.9%; RR 0.44) and substantially reduced overall mortality, with acceptable side effects.
SPCG-7/SFUO-3, The Lancet, Published Jan 2009Read on PubMedTen-year follow-up of radiation therapy oncology group protocol 92-02: a phase III trial of the duration of elective androgen deprivation in locally advanced prostate cancer
Conclusion: In locally advanced (T2c-T4) prostate cancer, adding 24 months of goserelin after 4 months of ADT before and during RT improved every 10-year end point except OS, although Gleason 8-10 tumors showed a survival advantage.
RTOG 92-02, Journal of Clinical Oncology, Published May 2008Read on PubMedShort-term neoadjuvant androgen deprivation therapy and external-beam radiotherapy for locally advanced prostate cancer: long-term results of RTOG 8610
Conclusion: In locally advanced (bulky T2-4) prostate cancer, 4 months of neoadjuvant and concurrent ADT with EBRT improved 10-year disease-specific mortality (23% vs 36%), distant metastasis, DFS and biochemical failure versus EBRT alone, without a significant OS difference or more fatal cardiac events.
RTOG 86-10, Journal of Clinical Oncology, Published Feb 2008Read on PubMedImproved survival in patients with locally advanced prostate cancer treated with radiotherapy and goserelin
Conclusion: In locally advanced prostate cancer, 3 years of goserelin started at the same time as external-beam RT improved 5-year OS versus RT alone (79% vs 62%) and also improved local control.
EORTC 22863, New England Journal of Medicine, Published Jul 1997Read on PubMedPost-prostatectomy Radiation5
Adjuvant or early salvage radiotherapy for the treatment of localised and locally advanced prostate cancer: a prospectively planned systematic review and meta-analysis of aggregate data
Conclusion: In a prospectively planned meta-analysis of three RCTs (2,153 men) after radical prostatectomy, adjuvant RT did not improve event-free survival versus early salvage RT (HR 0.95), suggesting early salvage is the preferable policy until long-term data are available.
ARTISTIC, The Lancet, Published Oct 2020Read on PubMedTiming of radiotherapy after radical prostatectomy (RADICALS-RT): a randomised, controlled phase 3 trial
Conclusion: After radical prostatectomy in men with at least one risk factor, adjuvant RT did not improve 5-year biochemical progression-free survival versus observation with salvage RT for PSA progression (85% vs 88%; HR 1.10) and increased urinary morbidity.
RADICALS-RT, The Lancet, Published Oct 2020Read on PubMedAdjuvant radiotherapy versus wait-and-see after radical prostatectomy: 10-year follow-up of the ARO 96-02/AUO AP 09/95 trial
Conclusion: In pT3 prostate cancer with undetectable PSA after radical prostatectomy, adjuvant RT improved 10-year progression-free survival versus wait-and-see (56% vs 35%; HR 0.51) but did not significantly improve metastasis-free or overall survival, endpoints the trial was underpowered for.
ARO 96-02, European Urology, Published Aug 2014Read on PubMedPostoperative radiotherapy after radical prostatectomy for high-risk prostate cancer: long-term results of a randomised controlled trial (EORTC trial 22911)
Conclusion: In prostate cancer extending beyond the prostate after radical prostatectomy, immediate postoperative RT improved biochemical progression-free survival (HR 0.49) and local control versus wait-and-see at a median 10.6 years, but the clinical progression-free survival benefit was not maintained.
EORTC 22911, The Lancet, Published Dec 2012Read on PubMedAdjuvant radiotherapy for pathological T3N0M0 prostate cancer significantly reduces risk of metastases and improves survival: long-term followup of a randomized clinical trial
Conclusion: In men with pT3N0M0 prostate cancer after radical prostatectomy, adjuvant RT (60-64 Gy) significantly improved metastasis-free survival (HR 0.71) and OS (HR 0.72) versus observation.
SWOG 8794, The Journal of Urology, Published Mar 2009Read on PubMedMetastatic Hormone-Sensitive9
Oral Relugolix for Androgen-Deprivation Therapy in Advanced Prostate Cancer
Conclusion: In men with advanced prostate cancer, oral relugolix achieved rapid, sustained testosterone suppression superior to leuprolide injections (castration maintained through 48 weeks in 96.7% vs 88.8%), with a 54% lower risk of major adverse cardiovascular events.
HERO, New England Journal of Medicine, Published Jun 2020Read on PubMedARCHES: A Randomized, Phase III Study of Androgen Deprivation Therapy With Enzalutamide or Placebo in Men With Metastatic Hormone-Sensitive Prostate Cancer
Conclusion: In men with metastatic hormone-sensitive prostate cancer, adding enzalutamide to ADT significantly reduced the risk of radiographic progression or death versus placebo plus ADT (HR 0.39), including those with low-volume disease or prior docetaxel, with no unexpected adverse events.
ARCHES, Journal of Clinical Oncology, Published Nov 2019Read on PubMedEnzalutamide with Standard First-Line Therapy in Metastatic Prostate Cancer
Conclusion: In men with metastatic hormone-sensitive prostate cancer on testosterone suppression, adding enzalutamide significantly prolonged progression-free and overall survival versus a standard nonsteroidal antiandrogen (HR for death 0.67), with more seizures and toxic effects, especially with early docetaxel.
ENZAMET, New England Journal of Medicine, Published Jul 2019Read on PubMedApalutamide for Metastatic, Castration-Sensitive Prostate Cancer
Conclusion: In metastatic castration-sensitive prostate cancer, adding apalutamide to ADT significantly prolonged radiographic PFS (HR 0.48) and overall survival (HR 0.67) versus placebo plus ADT, without a substantially different side-effect profile.
TITAN, New England Journal of Medicine, Published Jul 2019Read on PubMedRadiotherapy to the primary tumour for newly diagnosed, metastatic prostate cancer (STAMPEDE): a randomised controlled phase 3 trial
Conclusion: In unselected men with newly diagnosed metastatic prostate cancer, adding prostate radiotherapy to standard of care improved failure-free survival (HR 0.76) but did not significantly improve overall survival (HR 0.92).
STAMPEDE, The Lancet, Published Dec 2018Read on PubMedAbiraterone for Prostate Cancer Not Previously Treated with Hormone Therapy
Conclusion: In men with locally advanced or metastatic prostate cancer starting long-term ADT, adding abiraterone and prednisolone significantly improved overall survival (HR 0.63) and failure-free survival (HR 0.29) versus ADT alone.
STAMPEDE, New England Journal of Medicine, Published Jul 2017Read on PubMedAbiraterone plus Prednisone in Metastatic, Castration-Sensitive Prostate Cancer
Conclusion: In men with newly diagnosed metastatic castration-sensitive prostate cancer, adding abiraterone acetate plus prednisone to ADT significantly improved overall survival (HR 0.62) and radiographic PFS (HR 0.47) versus ADT plus placebo.
LATITUDE, New England Journal of Medicine, Published Jul 2017Read on PubMedAddition of docetaxel, zoledronic acid, or both to first-line long-term hormone therapy in prostate cancer (STAMPEDE): survival results from an adaptive, multiarm, multistage, platform randomised controlled trial
Conclusion: In men starting first-line long-term hormone therapy for high-risk locally advanced, metastatic or recurrent prostate cancer, adding docetaxel improved overall survival (HR 0.78) at the cost of more adverse events, whereas zoledronic acid showed no evidence of survival benefit.
STAMPEDE, The Lancet, Published Mar 2016Read on PubMedChemohormonal Therapy in Metastatic Hormone-Sensitive Prostate Cancer
Conclusion: In men with metastatic hormone-sensitive prostate cancer, adding six cycles of docetaxel to ADT at initiation significantly prolonged overall survival versus ADT alone (median 57.6 vs 44.0 months; HR 0.61).
CHAARTED, New England Journal of Medicine, Published Aug 2015Read on PubMedNon-metastatic CRPC3
Darolutamide in Nonmetastatic, Castration-Resistant Prostate Cancer
Conclusion: In men with nonmetastatic CRPC and a PSA doubling time of 10 months or less continuing ADT, darolutamide significantly prolonged metastasis-free survival versus placebo (median 40.4 vs 18.4 months; HR 0.41), with a similar incidence of adverse events.
ARAMIS, New England Journal of Medicine, Published Mar 2019Read on PubMedEnzalutamide in Men with Nonmetastatic, Castration-Resistant Prostate Cancer
Conclusion: In men with nonmetastatic CRPC and a rapidly rising PSA (doubling time 10 months or less) continuing ADT, enzalutamide led to a significant 71% lower risk of metastasis or death than placebo (median metastasis-free survival 36.6 vs 14.7 months).
PROSPER, New England Journal of Medicine, Published Jun 2018Read on PubMedApalutamide Treatment and Metastasis-free Survival in Prostate Cancer
Conclusion: In men with nonmetastatic CRPC and a PSA doubling time of 10 months or less continuing ADT, apalutamide significantly prolonged metastasis-free survival (median 40.5 vs 16.2 months; HR 0.28) and time to symptomatic progression versus placebo.
SPARTAN, New England Journal of Medicine, Published Apr 2018Read on PubMedMetastatic CRPC: Pre-docetaxel4
Enzalutamide in metastatic prostate cancer before chemotherapy
Conclusion: In chemotherapy-naive men with metastatic prostate cancer progressing despite ADT, enzalutamide versus placebo significantly reduced the risk of radiographic progression (HR 0.19) and death (HR 0.71) and delayed initiation of chemotherapy.
PREVAIL, New England Journal of Medicine, Published Jul 2014Read on PubMedAbiraterone in metastatic prostate cancer without previous chemotherapy
Conclusion: In chemotherapy-naive metastatic CRPC, abiraterone plus prednisone versus prednisone alone improved radiographic PFS (HR 0.53) and significantly delayed clinical decline and chemotherapy initiation, with only a trend toward improved OS that did not cross the interim efficacy boundary.
COU-AA-302, New England Journal of Medicine, Published Jan 2013Read on PubMedSipuleucel-T immunotherapy for castration-resistant prostate cancer
Conclusion: In men with metastatic CRPC, sipuleucel-T autologous cellular immunotherapy versus placebo prolonged OS (HR 0.78; median 25.8 vs 21.7 months) but had no effect on time to disease progression.
IMPACT, New England Journal of Medicine, Published Jul 2010Read on PubMedDocetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer
Conclusion: In men with metastatic hormone-refractory prostate cancer, docetaxel every 3 weeks plus prednisone improved survival versus mitoxantrone plus prednisone (HR for death 0.76), with better pain, PSA and quality-of-life responses; weekly docetaxel did not significantly improve survival.
TAX 327, New England Journal of Medicine, Published Oct 2004Read on PubMedMetastatic CRPC: Post-docetaxel7
Lutetium-177-PSMA-617 for Metastatic Castration-Resistant Prostate Cancer
Conclusion: In PSMA-positive metastatic CRPC previously treated with an androgen-receptor-pathway inhibitor and taxane, adding 177Lu-PSMA-617 to standard care prolonged imaging-based PFS (HR 0.40) and OS (HR 0.62) versus standard care alone.
VISION, New England Journal of Medicine, Published Sep 2021Read on PubMed[177Lu]Lu-PSMA-617 versus cabazitaxel in patients with metastatic castration-resistant prostate cancer (TheraP): a randomised, open-label, phase 2 trial
Conclusion: In men with PSMA-positive metastatic CRPC for whom cabazitaxel was the next standard treatment, 177Lu-PSMA-617 versus cabazitaxel produced more PSA responses (66% vs 37%) with fewer grade 3-4 adverse events (33% vs 53%).
TheraP, The Lancet, Published Feb 2021Read on PubMedOlaparib for Metastatic Castration-Resistant Prostate Cancer
Conclusion: In men with metastatic CRPC progressing on enzalutamide or abiraterone and harboring homologous recombination repair gene alterations, olaparib versus enzalutamide or abiraterone significantly prolonged imaging-based PFS in cohort A (HR 0.34), with better response and patient-reported end points.
PROfound, New England Journal of Medicine, Published May 2020Read on PubMedAlpha emitter radium-223 and survival in metastatic prostate cancer
Conclusion: In men with CRPC and bone metastases who had received, were ineligible for, or declined docetaxel, radium-223 versus placebo improved OS (median 14.9 vs 11.3 months; HR 0.70), and the trial was terminated for efficacy at interim analysis.
ALSYMPCA, New England Journal of Medicine, Published Jul 2013Read on PubMedIncreased survival with enzalutamide in prostate cancer after chemotherapy
Conclusion: In men with metastatic CRPC after chemotherapy, enzalutamide versus placebo significantly prolonged OS (median 18.4 vs 13.6 months; HR 0.63) and was superior on all secondary end points.
AFFIRM, New England Journal of Medicine, Published Sep 2012Read on PubMedAbiraterone and increased survival in metastatic prostate cancer
Conclusion: In metastatic CRPC previously treated with docetaxel, abiraterone acetate plus prednisone versus placebo plus prednisone prolonged OS (14.8 vs 10.9 months; HR 0.65), with more mineralocorticoid-related adverse events.
COU-AA-301, New England Journal of Medicine, Published May 2011Read on PubMedDenosumab versus zoledronic acid for treatment of bone metastases in men with castration-resistant prostate cancer: a randomised, double-blind study
Conclusion: In men with bone metastases from CRPC, denosumab was better than zoledronic acid for preventing skeletal-related events, prolonging time to first event (median 20.7 vs 17.1 months; HR 0.82), with more hypocalcemia.
Fizazi et al., The Lancet, Published Mar 2011Read on PubMedKidney Cancer
12 papersSurgery2
A prospective, randomised EORTC intergroup phase 3 study comparing the oncologic outcome of elective nephron-sparing surgery and radical nephrectomy for low-stage renal cell carcinoma
Conclusion: For small (≤5 cm) solitary tumors suspicious for RCC, nephron-sparing surgery and radical nephrectomy both gave excellent oncologic results; NSS seemed significantly less effective than RN for OS in the ITT population (HR 1.50), but the trend was no longer significant in RCC patients.
EORTC 30904, European Urology, Published Apr 2011Read on PubMedRadical nephrectomy with and without lymph-node dissection: final results of European Organization for Research and Treatment of Cancer (EORTC) randomized phase 3 trial 30881
Conclusion: In patients with resectable, clinically N0M0 RCC, adding a complete lymph-node dissection to radical nephrectomy did not significantly improve OS, time to progression, or PFS, and unsuspected lymph-node metastases were found in only 4.0%.
EORTC 30881, European Urology, Published Jan 2009Read on PubMedCytoreductive Nephrectomy4
Comparison of Immediate vs Deferred Cytoreductive Nephrectomy in Patients With Synchronous Metastatic Renal Cell Carcinoma Receiving Sunitinib: The SURTIME Randomized Clinical Trial
Conclusion: In synchronous metastatic clear-cell RCC, deferring cytoreductive nephrectomy until after 3 cycles of sunitinib did not improve the 28-week progression-free rate versus immediate CN, although more patients received sunitinib and OS was higher with the deferred approach (HR 0.57).
SURTIME, JAMA Oncology, Published Feb 2019Read on PubMedSunitinib Alone or after Nephrectomy in Metastatic Renal-Cell Carcinoma
Conclusion: In metastatic clear-cell RCC with MSKCC intermediate- or poor-risk disease, sunitinib alone was noninferior to cytoreductive nephrectomy followed by sunitinib for overall survival (HR 0.89; median 18.4 vs 13.9 months).
CARMENA, New England Journal of Medicine, Published Aug 2018Read on PubMedNephrectomy followed by interferon alfa-2b compared with interferon alfa-2b alone for metastatic renal-cell cancer
Conclusion: In patients with metastatic RCC who were candidates for nephrectomy, radical nephrectomy followed by interferon alfa-2b resulted in longer survival than interferon alfa-2b alone (median 11.1 vs 8.1 months).
SWOG 8949, New England Journal of Medicine, Published Dec 2001Read on PubMedRadical nephrectomy plus interferon-alfa-based immunotherapy compared with interferon alfa alone in metastatic renal-cell carcinoma: a randomised trial
Conclusion: In patients with metastatic RCC and good performance status, radical nephrectomy before interferon-alfa significantly improved time to progression and overall survival (median 17 vs 7 months; HR 0.54) compared with interferon-alfa alone.
EORTC 30947, The Lancet, Published Sep 2001Read on PubMedSystemic Therapy for Metastatic Disease3
Lenvatinib plus Pembrolizumab or Everolimus for Advanced Renal Cell Carcinoma
Conclusion: In previously untreated advanced RCC, lenvatinib plus pembrolizumab significantly prolonged PFS (HR 0.39) and OS (HR 0.66) versus sunitinib, whereas lenvatinib plus everolimus prolonged PFS but not OS.
CLEAR, New England Journal of Medicine, Published Apr 2021Read on PubMedNivolumab plus Cabozantinib versus Sunitinib for Advanced Renal-Cell Carcinoma
Conclusion: In previously untreated advanced clear-cell RCC, nivolumab plus cabozantinib significantly improved PFS (HR 0.51), OS (HR 0.60), and objective response versus sunitinib.
CheckMate 9ER, New England Journal of Medicine, Published Mar 2021Read on PubMedNivolumab plus Ipilimumab versus Sunitinib in Advanced Renal-Cell Carcinoma
Conclusion: In previously untreated intermediate- and poor-risk advanced clear-cell RCC, nivolumab plus ipilimumab significantly improved OS (HR 0.63) and objective response rate (42% vs 27%) versus sunitinib, although the PFS difference did not meet the prespecified significance threshold.
CheckMate 214, New England Journal of Medicine, Published Apr 2018Read on PubMedAdjuvant Therapy3
Adjuvant Pembrolizumab after Nephrectomy in Renal-Cell Carcinoma
Conclusion: In clear-cell RCC at high risk of recurrence after nephrectomy, about 1 year of adjuvant pembrolizumab significantly improved DFS versus placebo (24-month DFS 77.3% vs 68.1%; HR 0.68).
KEYNOTE-564, New England Journal of Medicine, Published Aug 2021Read on PubMedAdjuvant Sunitinib in High-Risk Renal-Cell Carcinoma after Nephrectomy
Conclusion: In locoregional clear-cell RCC at high risk of recurrence after nephrectomy, 1 year of adjuvant sunitinib significantly prolonged DFS versus placebo (median 6.8 vs 5.6 years; HR 0.76), at the cost of more toxic events; OS data were immature.
S-TRAC, New England Journal of Medicine, Published Dec 2016Read on PubMedAdjuvant sunitinib or sorafenib for high-risk, non-metastatic renal-cell carcinoma (ECOG-ACRIN E2805): a double-blind, placebo-controlled, randomised, phase 3 trial
Conclusion: In resected, high-risk non-metastatic RCC, 54 weeks of adjuvant sunitinib or sorafenib did not significantly improve DFS versus placebo (HR 1.02 and 0.97, respectively), and toxicity led to substantial treatment discontinuation despite dose reductions.
ASSURE, The Lancet, Published May 2016Read on PubMedBladder Cancer
16 papersNMIBC: BCG6
Durvalumab in combination with BCG for BCG-naive, high-risk, non-muscle-invasive bladder cancer (POTOMAC): final analysis of a randomised, open-label, phase 3 trial
Conclusion: Adding 1 year of durvalumab to BCG induction and maintenance significantly improved disease-free survival versus BCG alone in BCG-naive, high-risk NMIBC (HR 0.68), with a manageable safety profile.
POTOMAC, The Lancet, Published Nov 2025Read on PubMedIntravesical bacillus Calmette-Guerin versus mitomycin C for Ta and T1 bladder cancer
Conclusion: In medium/high-risk Ta/T1 bladder cancer, intravesical BCG did not significantly reduce recurrence compared with mitomycin C overall, but did in the high-risk subgroup, with no difference in progression or survival.
Cochrane review, Cochrane Database of Systematic Reviews, Published 2003Read on PubMedIntravesical bacillus Calmette-Guerin reduces the risk of progression in patients with superficial bladder cancer: a meta-analysis of the published results of randomized clinical trials
Conclusion: In this meta-analysis of 24 randomized trials in Ta/T1/CIS bladder cancer, intravesical BCG after TUR reduced the odds of progression by 27% (OR 0.73), but only in patients receiving maintenance, with no significant difference in overall survival.
Sylvester et al., The Journal of Urology, Published Nov 2002Read on PubMedMaintenance bacillus Calmette-Guerin immunotherapy for recurrent TA, T1 and carcinoma in situ transitional cell carcinoma of the bladder: a randomized Southwest Oncology Group Study
Conclusion: In carcinoma in situ or recurrent Ta/T1 bladder cancer at increased risk of recurrence, adding 3-week maintenance BCG after induction roughly doubled median recurrence-free survival versus induction alone (76.8 vs 35.7 months) and significantly prolonged worsening-free survival.
SWOG 8507, The Journal of Urology, Published Apr 2000Read on PubMedIntravesical Bacillus Calmette-Guerin in Ta and T1 Bladder Cancer
Conclusion: In medium/high-risk Ta/T1 bladder cancer, adding intravesical BCG to TUR significantly reduced recurrence compared with TUR alone across six randomized trials (12-month recurrence OR 0.30), with no BCG-related deaths but frequent cystitis.
Cochrane review, Cochrane Database of Systematic Reviews, Published 2000Read on PubMedA randomized trial of intravesical doxorubicin and immunotherapy with bacille Calmette-Guérin for transitional-cell carcinoma of the bladder
Conclusion: In rapidly recurrent Ta/T1 or carcinoma in situ bladder cancer, BCG gave better protection against recurrence than intravesical doxorubicin (5-year disease-free 37% vs 17% for Ta/T1 without CIS; CIS complete response 70% vs 34%), with more but rarely severe toxicity.
SWOG 8216, New England Journal of Medicine, Published Oct 1991Read on PubMedMIBC: Neoadjuvant Chemotherapy2
International phase III trial assessing neoadjuvant cisplatin, methotrexate, and vinblastine chemotherapy for muscle-invasive bladder cancer: long-term results of the BA06 30894 trial
Conclusion: In MIBC treated with cystectomy and/or RT, three cycles of neoadjuvant CMV significantly reduced the risk of death versus no neoadjuvant chemotherapy (HR 0.84), increasing 10-year survival from 30% to 36%.
BA06 30894, Journal of Clinical Oncology, Published Jun 2011Read on PubMedNeoadjuvant chemotherapy plus cystectomy compared with cystectomy alone for locally advanced bladder cancer
Conclusion: In T2–T4a MIBC, three cycles of neoadjuvant MVAC before radical cystectomy, versus cystectomy alone, increased the rate of no residual cancer (38% vs 15%) and was associated with improved median survival (77 vs 46 months, P=0.06).
SWOG 8710, New England Journal of Medicine, Published Aug 2003Read on PubMedMIBC: Lymphadenectomy2
Standard or Extended Lymphadenectomy for Muscle-Invasive Bladder Cancer
Conclusion: In cT2–T4a MIBC undergoing radical cystectomy, extended lymphadenectomy did not improve disease-free survival (HR 1.10) or overall survival versus standard bilateral lymphadenectomy and was associated with higher perioperative morbidity and mortality.
SWOG S1011, New England Journal of Medicine, Published Oct 2024Read on PubMedExtended Versus Limited Lymph Node Dissection in Bladder Cancer Patients Undergoing Radical Cystectomy: Survival Results from a Prospective, Randomized Trial
Conclusion: In T1G3 or muscle-invasive (T2–T4a M0) urothelial bladder cancer undergoing radical cystectomy, extended LND up to the inferior mesenteric artery failed to show superiority over limited LND for RFS (HR 0.84), CSS, or OS.
LEA (AUO AB 25/02), European Urology, Published Apr 2019Read on PubMedUpper Tract Urothelial Carcinoma
1 paperAndrology
2 papersVoiding Dysfunction
7 papersBPH: Medical Therapy2
The effects of combination therapy with dutasteride and tamsulosin on clinical outcomes in men with symptomatic benign prostatic hyperplasia: 4-year results from the CombAT study
Conclusion: In men with moderate-to-severe LUTS due to BPH and prostatic enlargement, dutasteride plus tamsulosin was significantly superior to tamsulosin but not dutasteride alone in reducing acute urinary retention or BPH-related surgery over 4 years, and superior to both monotherapies for clinical progression and symptoms.
CombAT, European Urology, Published Jan 2010Read on PubMedThe long-term effect of doxazosin, finasteride, and combination therapy on the clinical progression of benign prostatic hyperplasia
Conclusion: In men with BPH, long-term doxazosin plus finasteride reduced the risk of overall clinical progression significantly more than either drug alone (66% risk reduction versus placebo), and combination therapy or finasteride alone reduced acute urinary retention and the need for invasive therapy.
MTOPS, New England Journal of Medicine, Published Dec 2003Read on PubMedOveractive Bladder5
OnabotulinumtoxinA vs Sacral Neuromodulation on Refractory Urgency Urinary Incontinence in Women: A Randomized Clinical Trial
Conclusion: In women with refractory urgency urinary incontinence, onabotulinumtoxinA 200 U gave a small, statistically significant greater reduction in daily incontinence episodes than sacral neuromodulation (-3.9 vs -3.3 per day) of uncertain clinical importance, but more UTIs and need for transient self-catheterization.
ROSETTA, JAMA, Published Oct 2016Read on PubMedPercutaneous tibial nerve stimulation for the long-term treatment of overactive bladder: 3-year results of the STEP study
Conclusion: Among OAB patients who responded to 12 weekly PTNS treatments in SUmiT, most safely sustained symptom improvement to 3 years (estimated 77% with moderate or marked improvement) with an average of 1 treatment per month.
STEP, The Journal of Urology, Published Jun 2013Read on PubMedAnticholinergic therapy vs. onabotulinumtoxinA for urgency urinary incontinence
Conclusion: In women with idiopathic urgency urinary incontinence, daily oral anticholinergics and a single 100 U onabotulinumtoxinA injection gave similar reductions in daily incontinence episodes, with onabotulinumtoxinA giving more complete resolution (27% vs 13%) but higher rates of transient urinary retention and UTIs.
ABC, New England Journal of Medicine, Published Nov 2012Read on PubMedRandomized trial of percutaneous tibial nerve stimulation versus Sham efficacy in the treatment of overactive bladder syndrome: results from the SUmiT trial
Conclusion: In adults with OAB, 12 weeks of weekly PTNS significantly improved global bladder symptoms versus sham (54.5% vs 20.9% moderately or markedly improved), with significant improvements in voiding diary parameters and no serious device-related adverse events.
SUmiT, The Journal of Urology, Published Apr 2010Read on PubMedRandomized trial of percutaneous tibial nerve stimulation versus extended-release tolterodine: results from the overactive bladder innovative therapy trial
Conclusion: In adults with OAB, 12 weeks of weekly PTNS produced significantly better patient-assessed symptom improvement than extended-release tolterodine (79.5% vs 54.8% cured or improved), with comparable objective improvements in voiding diary measures.
OrBIT, The Journal of Urology, Published Sep 2009Read on PubMedFemale Pelvic Floor
15 papersStress Urinary Incontinence4
A randomized trial of urodynamic testing before stress-incontinence surgery
Conclusion: In women with uncomplicated, demonstrable SUI, preoperative office evaluation alone was noninferior to office evaluation plus urodynamic testing for 12-month treatment success (77.2% vs 76.9%), with no significant differences in secondary outcomes.
ValUE, New England Journal of Medicine, Published May 2012Read on PubMedRetropubic versus transobturator midurethral slings for stress incontinence
Conclusion: In women with SUI, retropubic and transobturator midurethral slings were equivalent for 12-month objective success (80.8% vs 77.7%), while subjective success was similar but did not meet equivalence criteria; retropubic slings caused more voiding dysfunction requiring surgery, transobturator slings more neurologic symptoms.
TOMUS, New England Journal of Medicine, Published Jun 2010Read on PubMedContinence pessary compared with behavioral therapy or combined therapy for stress incontinence: a randomized controlled trial
Conclusion: In women with SUI, behavioral therapy gave greater satisfaction (75% vs 63%) and fewer bothersome symptoms than a continence pessary at 3 months, but differences did not persist to 12 months, and combined therapy was not superior to single-modality therapy.
ATLAS, Obstetrics & Gynecology, Published Mar 2010Read on PubMedBurch colposuspension versus fascial sling to reduce urinary stress incontinence
Conclusion: In women with SUI and urethral hypermobility, the autologous rectus fascial sling achieved higher 24-month success than Burch colposuspension (overall 47% vs 38%; stress-specific 66% vs 49%) but caused more UTIs, voiding difficulty, and postoperative urge incontinence.
SISTEr, New England Journal of Medicine, Published May 2007Read on PubMedPelvic Organ Prolapse5
Effect of sacrospinous hysteropexy with graft vs vaginal hysterectomy with uterosacral ligament suspension on treatment failure in women with uterovaginal prolapse: 5-year results of a randomized clinical trial
Conclusion: Through 5 years in postmenopausal women with symptomatic uterovaginal prolapse, sacrospinous hysteropexy with graft had a lower composite failure rate than vaginal hysterectomy with uterosacral ligament suspension (adjusted HR 0.58; 37% vs 54%), with no meaningful differences in patient-reported outcomes.
eSUPeR, American Journal of Obstetrics & Gynecology, Published Aug 2021Read on PubMedEffect of Vaginal Mesh Hysteropexy vs Vaginal Hysterectomy With Uterosacral Ligament Suspension on Treatment Failure in Women With Uterovaginal Prolapse: A Randomized Clinical Trial
Conclusion: In postmenopausal women with symptomatic uterovaginal prolapse, vaginal mesh hysteropexy did not significantly reduce composite treatment failure versus vaginal hysterectomy with uterosacral ligament suspension after 3 years (adjusted HR 0.62; 36-month failure 26% vs 38%), though imprecision precluded a definitive conclusion.
SUPeR, JAMA, Published Sep 2019Read on PubMedEffect of Uterosacral Ligament Suspension vs Sacrospinous Ligament Fixation With or Without Perioperative Behavioral Therapy for Pelvic Organ Vaginal Prolapse on Surgical Outcomes and Prolapse Symptoms at 5 Years in the OPTIMAL Randomized Clinical Trial
Conclusion: Five years after vaginal apical prolapse surgery, surgical failure did not differ significantly between uterosacral ligament suspension and sacrospinous ligament fixation (61.5% vs 70.3%), nor did perioperative pelvic floor muscle training improve anatomic or symptom outcomes; failure rose over time, though symptoms stayed improved.
eOPTIMAL, JAMA, Published Apr 2018Read on PubMedComparison of 2 transvaginal surgical approaches and perioperative behavioral therapy for apical vaginal prolapse: the OPTIMAL randomized trial
Conclusion: In women with apical prolapse and SUI, vaginal uterosacral ligament suspension and sacrospinous ligament fixation did not differ significantly in 2-year surgical success (59.2% vs 60.5%) or serious adverse events; perioperative behavioral therapy with pelvic floor muscle training did not improve urinary or prolapse outcomes.
OPTIMAL, JAMA, Published Mar 2014Read on PubMedThe PESSRI study: symptom relief outcomes of a randomized crossover trial of the ring and Gellhorn pessaries
Conclusion: In women with prolapse (median POP-Q stage III), the ring-with-support and Gellhorn pessaries, each used for 3 months in a randomized crossover, were effective and equivalent in relieving protrusion and voiding symptoms.
PESSRI, American Journal of Obstetrics & Gynecology, Published Apr 2007Read on PubMedProlapse-associated Incontinence3
Long-term outcomes following abdominal sacrocolpopexy for pelvic organ prolapse
Conclusion: Over 7 years after abdominal sacrocolpopexy in stress-continent women with POP, failure rates rose with or without concomitant Burch urethropexy, urethropexy prevented SUI longer, and mesh erosion probability reached 10.5%, so effectiveness should be balanced against long-term mesh or suture erosion risk.
eCARE, JAMA, Published May 2013Read on PubMedA midurethral sling to reduce incontinence after vaginal prolapse repair
Conclusion: In women without SUI symptoms undergoing vaginal prolapse surgery, a prophylactic midurethral sling versus sham incisions lowered urinary incontinence at 3 and 12 months (27.3% vs 43.0% at 12 months) but increased adverse events, including bladder perforation and UTI.
OPUS, New England Journal of Medicine, Published Jun 2012Read on PubMedAbdominal sacrocolpopexy with Burch colposuspension to reduce urinary stress incontinence
Conclusion: In women without stress incontinence undergoing abdominal sacrocolpopexy for prolapse, adding Burch colposuspension significantly reduced postoperative stress incontinence at 3 months (33.6% vs 57.4%) without increasing other lower urinary tract symptoms.
CARE, New England Journal of Medicine, Published Apr 2006Read on PubMed