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Addition of Metastasis-Directed Therapy to Standard of Care for Oligometastatic Disease: Primary Aggregated Analysis of All Baskets from the Phase II Randomized EXTEND Trial
Adding metastasis-directed therapy (MDT — radiotherapy in 98% of lesions) to standard-of-care systemic therapy improved progression-free survival in oligometastatic disease: HR 0.54 (95% CI 0.41-0.72; P<.001) in the randomized phase 2 EXTEND trial (334 patients in the per-protocol analysis, median follow-up 53 months). The benefit persisted after excluding the two prostate baskets (HR 0.60; 95% CI…
High-dose radiotherapy in patients with high-risk prostate cancers treated with long-term androgen deprivation therapy (GETUG AFU 18): a randomised, phase 3 trial
The randomised phase 3 GETUG AFU 18 trial compared dose-escalated radiotherapy (80 Gy) with standard-dose radiotherapy (70 Gy) in high-risk prostate cancer treated with long-term androgen deprivation therapy. In total 505 patients were enrolled (250 vs 255). At 10 years, progression-free survival was 83.6% (95% CI 77.8–88.0) versus 72.2% (65.3–78.0), stratified HR 0.56 (95% CI 0.40–0.78; p<0.0001)…
Radiotherapy dose intensification for high-risk prostate cancer—what is gained?
The GETUG-AFU 18 phase 3 trial (n=505, 25 centres, France) showed that escalating radiotherapy from 70 Gy to 80 Gy alongside 3 years of androgen deprivation therapy significantly improved biochemical or clinical progression-free survival in high-risk prostate cancer, from 72.2% to 83.6% at 10 years (stratified HR 0.56, 95% CI 0.40–0.78). At 5 years, the benefit was more modest (88.1% vs 91.4%). Th…
pTVG-HP DNA vaccine in PSA-recurrent prostate cancer: median survival 13.4 vs 8.6 years in long-term analysis of a randomized phase 2 trial
In a randomized phase 2 trial (NCT01341652), the pTVG-HP DNA vaccine encoding prostatic acid phosphatase was associated with a median overall survival of 13.4 years versus 8.6 years with placebo (48 vs 49 patients, HR 0.42; 95% CI, 0.20-0.90) in men with PSA-recurrent, non-metastatic, non-castrate prostate cancer, at a median follow-up of 4.1 years. Median time to starting androgen deprivation the…
FDA Staff Raises Concerns on Breast, Prostate Cancer Drug Applications
FDA staff have raised concerns about the benefit-risk profiles of two cancer drug applications targeting breast and prostate cancer, ahead of the first Oncologic Drugs Advisory Committee (ODAC) meeting since July of last year. The advisory committee is set to convene on Thursday to evaluate both applications, despite positive clinical trial results cited by the drug sponsors. The FDA's reservation…
FDA Panel Endorses Capivasertib Use in Prostate Cancer
An FDA advisory panel voted 7-1, with one abstention, to endorse the use of capivasertib (Truqap) for the treatment of an aggressive subtype of prostate cancer. The Oncologic Drugs Advisory Committee's favorable recommendation signals that full FDA approval may follow in the coming months. Capivasertib is an AKT pathway inhibitor previously approved for breast cancer, and its potential expansion i…
Radiographic Progression With and Without Prostate-Specific Antigen Rise in Patients With Advanced Prostate Cancer Treated With Enzalutamide
A study published in the Journal of Clinical Oncology examined patterns of radiographic progression in patients with advanced prostate cancer receiving enzalutamide, distinguishing between cases with and without a concurrent rise in prostate-specific antigen (PSA). The research provides important insights into how disease progression manifests differently in patients on androgen receptor-targeted …
Pain and health-related quality-of-life outcomes with darolutamide in metastatic hormone-sensitive prostate cancer (ARANOTE): secondary and exploratory analyses of a multicentre, randomised, placebo-controlled, phase 3 trial
Secondary and exploratory analyses from the phase 3 ARANOTE trial demonstrate that darolutamide combined with androgen deprivation therapy (ADT) provides clinically meaningful delays in pain progression and time to deterioration of overall wellbeing in patients with metastatic hormone-sensitive prostate cancer (mHSPC). These patient-reported outcome data complement the previously established survi…
Alliance A222001: Oxybutynin Versus Placebo for the Treatment of Hot Flashes in Patients Receiving Androgen-Deprivation Therapy for Prostate Cancer
A randomized, placebo-controlled trial (Alliance A222001) published in the Journal of Clinical Oncology evaluated oxybutynin, an anticholinergic agent, for the management of hot flashes in prostate cancer patients undergoing androgen-deprivation therapy (ADT). Hot flashes are among the most common and distressing side effects of ADT, significantly affecting quality of life for a large proportion o…
Trial Design and Objectives for Patients With Prostate Cancer: Recommendations From the Prostate Cancer Working Group 4
The Prostate Cancer Working Group 4 (PCWG4) has published updated consensus recommendations for clinical trial design and endpoint selection in prostate cancer, appearing in the Journal of Clinical Oncology. Building on the widely adopted PCWG3 framework from 2016, the new guidelines reflect the rapidly evolving treatment landscape that now includes PARP inhibitors, radioligand therapies, and nove…