Prostate Cancer
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Jul 20 – Jul 27, 2026
A phase I dose-escalation/expansion study of fractionated-dose and multiple cycle anti-PSMA-targeted alpha emitter 225Ac-J591 in patients with prostate cancer.
CLIN CANCER RES · Q1 JOURNAL - RANK #29/326TOP-TIER
This phase I, open-label dose-escalation/expansion trial prospectively evaluated two 225Ac-J591 prostate-specific membrane antigen–targeted radiotherapeutic regimens in men with metastatic castration-resistant prostate cancer. Forty-two patients received a single fractionated cycle (45–65 kBq/kg on days 1 and 15) and 18 received up to four 6-weekly cycles at the same activity; prior 177Lu-PSMA therapy was allowed in predefined cohorts. Dose-limiting toxicities occurred in 3/42 patients on the fractionated schedule, establishing a recommended phase-II dose of 60 kBq/kg × 2, whereas 7/18 patients on the multiple-cycle regimen experienced DLTs, leading to discontinuation of that approach. Hematologic adverse events were frequent (thrombocytopenia 93% overall, grade ≥3 in 32%) and xerostomia occurred in 62%; PSA declines ≥50% were achieved by 60% of fractionated-dose recipients versus 28% of multiple-cycle recipients. The authors conclude that fractionated 225Ac-J591 is tolerable and shows promising antitumor activity warranting further study.
10.1158/1078-0432.CCR-26-0689
Patient-reported Outcomes After Prostate Stereotactic Body Radiotherapy at 5 yr: Results from the PACE-B Trial.
EUR UROL · Q1 JOURNAL - RANK #3/133TOP-TIER
This phase 3 international randomized PACE-B trial compared stereotactic body radiotherapy (SBRT) versus conventionally fractionated radiotherapy (CRT) in men with localized prostate cancer, reporting patient-reported outcomes (PROMs) from baseline to 5 years. At 5 years, urinary incontinence outcomes were similar: leak-free 64% (164/258) SBRT vs 69% (172/249) CRT, pad-free 91% (233/257) SBRT vs 90% (225/250) CRT, and moderate/big leakage 6% (15/250) SBRT vs 4% (9/244) CRT. Sexual function declined in both groups: intercourse-adequate erections fell from 35% (133/374) to 17% (43/250) for SBRT and from 40% (157/391) to 20% (47/240) for CRT; moderate/big sexual problems rose to 31% (74/242) SBRT and 32% (77/238) CRT. Bowel effects were low and comparable (moderate/big bowel problems 5% at 5 years in both arms; stool incontinence 2% SBRT vs 3% CRT).
10.1016/j.eururo.2026.05.034
Jul 13 – Jul 20, 2026
Quality of life results of addition of androgen deprivation therapy and pelvic lymph node treatment to prostate bed salvage radiotherapy: NRG Oncology/RTOG 0534 SPPORT.
INT J RADIAT ONCOL · Q1 JOURNAL - RANK #14/212
This randomized, prospective NRG Oncology/RTOG 0534 SPPORT trial assessed quality of life (QOL) among men with detectable PSA after prostatectomy, comparing PBRT alone (Arm 1), 4–6 months of short-term ADT plus PBRT (Arm 2), and pelvic lymph node RT plus ADT plus PBRT (Arm 3). QOL was measured at baseline, 6 weeks after RT start, and 1 and 5 years post-RT using EPIC, HSCL-25, EQ-5D, and QALYs, with pairwise tests and mixed-effects modeling controlling for multiplicity. EPIC bowel/urinary scores dropped at 6 weeks and improved by years 1 and 5 but not to baseline; sexual and hormonal domains were worse with ADT at 6 weeks and 1 year, with no arm differences at 5 years; HSCL-25 differences at 6 weeks were not clinically significant. Freedom-from-progression QALY means favored intensification (5.5 vs 6.2 vs 6.6 years for Arms 1, 2, 3; Arms 3 and 2 significantly over Arm 1), while overall survival QALYs did not differ.
10.1016/j.ijrobp.2026.06.3085
Jul 06 – Jul 13, 2026
Acute toxicity and quality of life with stereotactic body radiotherapy versus conventional fractionated intensity-modulated radiotherapy to the prostate and pelvis in high-risk prostate cancer (SRAM): A randomized phase II trial.
INT J RADIAT ONCOL · Q1 JOURNAL - RANK #14/212
This randomized phase II trial evaluated the impact of once-weekly stereotactic body radiotherapy (SBRT) versus conventional fractionated intensity-modulated radiotherapy (IMRT) to the prostate and pelvis in 121 patients with high-risk prostate cancer. Investigators administered SBRT (40 Gy/5 weekly fractions for prostate, 36.25 Gy for seminal vesicles, 25 Gy for pelvis) or IMRT (76 Gy/38 daily fractions for prostate/pelvis) plus androgen deprivation therapy for 18–24 months. They observed lower acute grade ≥2 GI toxicity with SBRT (8.3%) compared with IMRT (39.0%, p<0.0001), while grade ≥2 GU toxicity was 23.3% versus 36.1% (p=0.126). SBRT significantly reduced acute GI toxicity, resulted in comparable GU safety with no grade ≥3 events, and improved early patient-reported outcomes, justifying additional study in phase III trials.
10.1016/j.ijrobp.2026.06.3080
Quality of Life After Postprostatectomy Radiotherapy: A TROG 08.03 RAVES Randomized Controlled Trial Substudy.
EUR UROL ONCOL · Q1 JOURNAL - RANK #7/133
This planned secondary analysis of the TROG 08.03 RAVES randomized trial evaluated whether timing of postprostatectomy radiotherapy (adjuvant vs salvage triggered by PSA >0.2 ng/ml) affects patient-reported quality of life. QOL was assessed longitudinally using EORTC QLQ-C30 and QLQ-PR25, with minimal clinically important change defined as >0.5 SD decline from baseline over 1–5 years. Compared with salvage patients who did not receive RT, adjuvant RT was associated with more bowel symptom MCIC events and higher severe urinary incontinence at 5 years (16% vs 2%, p=0.01); however, among those who received RT, adjuvant vs salvage showed no significant differences in urinary, bowel, or sexual function 1–5 years after RT. Regression indicated sRT timing had no significant impact, suggesting postprostatectomy RT modestly worsens bowel symptoms and long-term incontinence, but timing has limited QOL implications.
10.1016/j.euo.2026.06.014
Jun 29 – Jul 06, 2026
Cancer detection in the European Randomised Study of Screening for Prostate Cancer (ERSPC).
BJU INT · Q1 JOURNAL - RANK #18/133
The study aimed to comprehensively evaluate repeated screening rounds and the detection of low- versus high-grade prostate cancers in men aged 55-69 across ERSPC trial centres (excluding France) within the European Randomised Study of Screening for Prostate Cancer. Participants were randomized to screening or control arms, with analyses stratified by screening attendance and cancer grade. Cancer detection rates (CDRs) for low-grade cases remained consistently higher than for intermediate- and high-grade cancers, with CDR trends fluctuating across centres and screening cycles; in Spain, high-grade CDRs increased with subsequent screenings. Findings showed decreasing low-grade cancer detection and rising interval/non-attender cases, suggesting reduced efficacy of uniform screening and advocating for tailored screening protocols.
10.1111/bju.70380
Ablative radiotherapy in castration-resistant prostate cancer.
BJU INT · Q1 JOURNAL - RANK #18/133
This monocentric, randomized phase II clinical trial aimed to assess the oncological benefit of ablative radiotherapy in castration-resistant prostate cancer patients with up to five metastases. Thirty patients were randomized (2:1) to either metastasis-directed therapy (MDT) or observation, and the primary endpoint was PSA progression within one year. PSA progression occurred in 44% of MDT patients versus 75% of observational patients (P=0.14), with a significant median time difference to progression (12.4 vs. 2.9 months, P=0.03). Despite the small sample size and single-center design, interim results suggest MDT may effectively delay PSA progression, warranting further multi-center studies (ClinicalTrials.gov: NCT04141709).
10.1111/bju.70368
Impact of hepatotoxicity and lipid metabolism-related toxicity on survival and quality of life in patients with high-volume metastatic hormone-sensitive prostate cancer treated with rezvilutamide in the CHART trial: a post hoc analysis.
BMC MED · Q1 JOURNAL - RANK #19/332
This post hoc analysis used data from 323 patients with high-volume metastatic hormone-sensitive prostate cancer (mHSPC) receiving rezvilutamide plus ADT, evaluating how hepatotoxicity and lipid metabolism-related toxicity (LMRT) influence survival and quality of life (QoL). The CHART study was a randomized, prospective trial that previously demonstrated significant improvements in rPFS and OS with rezvilutamide plus ADT compared with bicalutamide plus ADT. Any-grade hepatotoxicity and LMRT occurred in 24.6% and 56.7% of patients, respectively, with LMRT being associated with longer rPFS (HR, 0.59) and OS (HR, 0.59) and grade ≥3 LMRT linked to greater QoL gains. The findings suggest that LMRT may be a marker of improved outcomes, while hepatotoxicity was not significantly associated with survival or QoL.
10.1186/s12916-026-04985-8
Clinically relevant endpoints and quality-of-life outcomes with darolutamide in patients with metastatic hormone-sensitive prostate cancer: Analyses of the phase III ARASENS trial.
EUR J CANCER · Q1 JOURNAL - RANK #45/326
The ARASENS trial evaluated the efficacy and safety of darolutamide combined with androgen deprivation therapy (ADT) and docetaxel in 1305 patients with metastatic hormone-sensitive prostate cancer (mHSPC) through a randomized, phase III design. Darolutamide significantly improved overall survival (primary endpoint) and delayed time to metastatic castration-resistant prostate cancer (hazard ratio 0.36, 95% CI 0.30-0.42) and pain progression (HR 0.79, 95% CI 0.66-0.95) compared to placebo, with no significant differences in pain interference/severity or quality-of-life scores. Treatment-emergent adverse events were low and similar between groups over a median follow-up of >3.5 years. The study concludes that darolutamide triplet therapy is a standard-of-care option for mHSPC, offering long-term benefits without cumulative toxicity or HRQoL deterioration.
10.1016/j.ejca.2026.116888
SBRT plus abiraterone acetate and ADT versus abiraterone acetate and ADT in oligometastatic castrate-resistant prostate cancer (ARTO): long-term, unplanned overall survival analysis of an open-label, randomised, phase 2 trial.
LANCET ONCOL · Q1 JOURNAL - RANK #8/326TOP-TIER
This open-label, multicentre, phase 2 randomized trial compared androgen deprivation therapy plus abiraterone acetate with or without stereotactic body radiotherapy (SBRT) as metastasis-directed therapy in oligometastatic castrate-resistant prostate cancer patients across 16 sites in Italy. Patients (N=157) were prospectively randomized (1:1), and the unplanned analysis assessed long-term overall survival after a median follow-up of 53 months. Median overall survival was 50 months (95% CI 36-NR) in the control group versus not reached (55-NR) in the experimental group, with a hazard ratio of 0.55 (95% CI 0.33-0.92; p=0.021); grade 3-4 infectious complications were more frequent in controls. The trial demonstrated a significant overall survival benefit from adding SBRT to systemic therapy.
10.1016/S1470-2045(26)00178-6
Jun 22 – Jun 29, 2026
AI-Based Pathology classifier Predicts Sensitivity to Enzalutamide in Metastatic Hormone-Sensitive Prostate Cancer: A Biomarker Analysis of the ENZAMET Trial.
CLIN CANCER RES · Q1 JOURNAL - RANK #29/326TOP-TIER
This prespecified biomarker analysis of the randomized ENZAMET trial tested whether a previously developed, locked Artificial Intelligence Pathology Image Classifier (APIC) predicts overall survival benefit from adding enzalutamide to androgen deprivation therapy (ADT) versus non-steroidal antiandrogen (NSAA) in metastatic hormone-sensitive prostate cancer. APIC was applied without retraining to digitized H&E specimens from 492 of 1125 participants (median follow-up 68.8 months), and treatment-by-biomarker interaction for OS was assessed with Cox models adjusted for clinical factors, with sensitivity analyses excluding early docetaxel. APIC significantly modified benefit (interaction p=0.014): APIC-negative tumors had improved OS with enzalutamide (HR 0.50, 95% CI 0.35–0.73; 60-month OS 76.5% vs 58.3%), whereas APIC-positive showed limited benefit (HR 1.04, 95% CI 0.67–1.62; 60-month OS 55.6% vs 58.8%); similar findings were seen in low-volume disease (interaction p=0.015) and without docetaxel. The authors conclude APIC-negative status identifies patients with substantial OS benefit from adding enzalutamide to ADT.
10.1158/1078-0432.CCR-26-0871
Efficacy and safety of darolutamide plus androgen-deprivation therapy in Black patients with metastatic hormone-sensitive prostate cancer from the phase 3 ARANOTE trial.
PROSTATE CANCER P D · Q1 JOURNAL - RANK #11/133
The phase 3 ARANOTE trial prospectively randomized men beginning androgen-deprivation therapy for metastatic hormone-sensitive prostate cancer 2:1 to darolutamide 600 mg twice daily or placebo in addition to ADT. This prespecified subgroup analysis examined 65 Black participants (darolutamide n=41; placebo n=24) to assess efficacy and safety. Darolutamide + ADT reduced the risk of radiological progression or death by 49% versus ADT alone, consistent with benefits in the overall 669-patient cohort; safety findings in Black patients were comparable between arms with no new signals. The investigators conclude that adding darolutamide to ADT offers clinically meaningful radiological progression-free survival improvement in Black patients with metastatic hormone-sensitive prostate cancer.
10.1038/s41391-026-01131-6
Jun 15 – Jun 22, 2026
Patient-reported outcomes in castration-resistant prostate cancer with bone metastases treated with radium-223 with or without olaparib.
CANCER-AM CANCER SOC · Q1 JOURNAL - RANK #68/326
This was a secondary patient-reported outcome (PRO) analysis of the multicenter, randomized, phase 2 COMRADE trial evaluating olaparib plus radium-223 versus radium-223 alone in metastatic castration-resistant prostate cancer with bone metastases. PROs were assessed using FACT-P and BPI at baseline and every 12 weeks among 74 evaluable patients (65% of 114 treated). No significant differences in FACT-P total score were observed at Week 12 (-4.87; 95% CI, -13.4 to 3.62) or Week 24 (1.79; 95% CI, -8.28 to 11.9), and BPI pain severity did not differ at either timepoint. The authors concluded that adding olaparib to radium-223 was not associated with significant PRO detriment, supporting tolerability of the combination.
10.1002/cncr.70496
Is there an association between acute, subacute, and late genitourinary quality of life with prostate SBRT boost?
RADIOTHER ONCOL · Q1 JOURNAL - RANK #22/212
This study aimed to determine associations between acute, subacute, and late genitourinary (GU) quality of life in men receiving prostate SBRT boost using a post-hoc analysis of the PROMETHEUS prospective phase II trial with 151 participants and a median follow-up of 60 months. GU QOL changes were evaluated using EPIC-26 scores and minimal clinically important differences (MCID), and associations were analyzed through logistic regression on incontinence, obstructive, and irritative domains. Late incontinence MCID was significantly linked with EOT and 12-month MCIDs (ORs: 3.55 [1.42-8.92], 8.72 [3.53-21.56]), prior TURP, and Rectafix vs SpaceOAR (OR: 2.6 [1.09-6.23]), while late irritative MCID was tied to poor baseline irritative function (OR 7.95 [1.71-36.91]) and subacute irritation (OR 5.47 [2.11-14.18]). The authors conclude baseline or subacute irritative symptoms are predictors for later GU toxicities, guiding closer follow-up for susceptible patients.
10.1016/j.radonc.2026.111650
Lutetium-177-PSMA I&T (Lu-PSMA) with radiosensitising capecitabine in patients with metastatic castration-resistant prostate cancer (mCRPC): results of phase Ia study.
EUR J NUCL MED MOL I · Q1 JOURNAL - RANK #10/212
This phase Ia prospective, 3 + 3 dose-escalation trial tested capecitabine as a radiosensitiser combined with lutetium-177-PSMA-I&T in 12 men with heavily pre-treated metastatic castration-resistant prostate cancer. Capecitabine was given orally at 275–1000 mg/m² twice daily on days 1–14 of a 42-day cycle, with Lu-PSMA administered on day 10, for up to six cycles; the primary endpoint was maximum tolerated dose, with secondary efficacy and safety measures including PSA-50 response, progression-free survival (PFS) and overall survival. No dose-limiting toxicities were observed, establishing 1000 mg/m² as the MTD; treatment-related adverse events were mainly nausea, fatigue and diarrhoea. Across all dose levels, 50 % of patients achieved a ≥50 % PSA decline, PSA-PFS was 4.7 months (95 % CI 2.3–21.6) and one of one evaluable patients had a partial radiographic response, supporting the regimen’s tolerability and preliminary activity.
10.1007/s00259-026-08006-x
Single-Fraction Stereotactic Body Radiotherapy for Localized Prostate Cancer: A Nonrandomized Clinical Trial.
JAMA ONCOL · Q1 JOURNAL - RANK #14/326TOP-TIER
This multicenter, single-arm, prospective phase 1/2 trial evaluated a single 19-Gy stereotactic body radiotherapy (SBRT) with urethra sparing for low- or intermediate-risk localized prostate cancer. Forty-five men were enrolled across five European and US centers (43 treated) between 2017-2022 and followed a median 55.3 months; primary endpoint was 3-year biochemical relapse-free survival (bRFS), with toxicity and quality-of-life secondary. Three-year bRFS reached 92.9% (95% CI 85.4-100), meeting the prespecified 96% target within the confidence limits; grade ≥2 genitourinary and gastrointestinal adverse events occurred in 9.8% and 4.9%, and only one grade 3 proctitis was observed. Single-fraction 19-Gy SBRT therefore achieved promising mid-term control with acceptable toxicity, supporting further study with longer follow-up.
10.1001/jamaoncol.2026.1886
Jun 08 – Jun 15, 2026
Moderate hypofractionated boost to the prostate with pelvic radiotherapy in high-risk prostate cancer (MOB-RT) - a phase 2 study: acute safety and quality of life outcomes.
RADIOTHER ONCOL · Q1 JOURNAL - RANK #22/212
This prospective phase 2 single-arm trial assessed moderately hypofractionated external beam radiotherapy to the prostate with pelvic elective nodal irradiation, simultaneous integrated boosts, and concomitant ADT in high-risk/node-positive prostate cancer. Patients received 60 Gy in 20 fractions to the prostate and 48 Gy ENI, with optional boosts to 68 Gy (intraprostatic MRI-defined disease) and 55 Gy (radiographically involved nodes); 100 were enrolled and 97 completed treatment. Acute grade≥2 GI toxicity at 3 months was 15.5% (one-sided 95% upper confidence bound 22.8%), acute grade≥2 GU toxicity was 26.8% (95% CI 18.3–36.8%), and there was no statistically significant detriment to mean GI or GU QoL (EPIC-26, IPSS). The study concludes this regimen has lower-than-expected acute toxicity and preserves short-term GI/GU quality of life.
10.1016/j.radonc.2026.111614
Feasibility and Efficacy of Reiki Versus Massage for Cancer-Related Fatigue in Patients With Breast and Prostate Cancer Receiving Hormone Therapy.
J NATL COMPR CANC NE · Q1 JOURNAL - RANK #17/326TOP-TIER
In this randomized, prospective trial, 87 patients with breast or prostate cancer receiving hormone therapy for at least eight weeks were assigned to massage therapy (two sessions) or Reiki (two or four sessions) to reduce moderate to severe cancer-related fatigue (CRF). The primary outcome was change in Brief Fatigue Inventory total score, analyzed with ANCOVA and reported with within-group effect sizes (Cohen’s d). All interventions significantly reduced CRF from baseline (P<.001), with Reiki producing more substantial symptom improvement (d=0.81–1.49) compared to massage (d=0.50–0.60). Researchers concluded that both interventions are safe, feasible options for managing CRF, with Reiki demonstrating the greatest benefits warranting further large-scale trials.
10.6004/jnccn.2026.7010
PROTEUS May Mean New SOC for Some Prostate Cancers.
CANCER DISCOV · Q1 JOURNAL - RANK #10/326TOP-TIER
The PROTEUS phase III trial prospectively investigated whether 6 months of apalutamide combined with androgen deprivation therapy (ADT), administered perioperatively, improves outcomes for patients with localized, high-risk prostate cancer versus perioperative ADT alone. The study assigned patients to receive either apalutamide plus ADT or ADT only prior to and following surgery. At 5 years, metastasis-free survival was 78.2% in the apalutamide plus ADT group, compared to 73.5% in the ADT-only group, demonstrating a reduction in metastases and death risk. The authors conclude that adding apalutamide to ADT may establish a new standard of care for this population.
10.1158/2159-8290.CD-NW2026-0068
Single-fraction HDR brachytherapy combined with SBRT for intermediate and high-risk prostate cancer: Oncologic and patient-reported outcomes from a prospective phase II study.
RADIOTHER ONCOL · Q1 JOURNAL - RANK #22/212
This prospective single-arm phase II clinical trial evaluated the efficacy and safety of combining a single 15 Gy high-dose-rate (HDR) brachytherapy boost with prostate-only stereotactic body radiotherapy (SBRT; 25 Gy in 5 fractions) in 76 men with intermediate- or high-risk prostate cancer treated between 2019-2021, with androgen deprivation therapy given per risk group. Patient-reported quality of life (EPIC-26, EORTC QLQ-PR25) was the primary endpoint; secondary endpoints included CTCAE-graded genitourinary (GU)/gastrointestinal (GI) toxicities, PSA kinetics, biochemical relapse-free survival (bRFS), metastasis-free survival (MFS) and overall survival over a median 48-month follow-up. No acute or late grade 3 GI toxicity occurred; late grade 3 GU toxicity was seen in 2 patients (2.6%), while acute and late grade 2 GU toxicities were 11.8% and 28.9%. Median PSA nadir was 0.04 ng/mL, with 4-year bRFS and MFS of 91% (95% CI 84-98%); urinary and bowel quality-of-life scores returned to baseline by 6 months. The study concludes that single-fraction HDR brachytherapy plus SBRT yields high 4-year biochemical control, acceptable toxicity, and preserved quality of life, supporting its use as an efficient dose-escalation strategy in intermediate/high-risk prostate cancer.
10.1016/j.radonc.2026.111639
Consolidative therapy for PSMA-avid lesions after 3 cycles of apalutamide plus androgen deprivation in metastatic hormone-sensitive prostate cancer: A prospective phase 2 single-arm trial.
EUR J NUCL MED MOL I · Q1 JOURNAL - RANK #10/212
This multicenter, single-arm, phase II trial in newly diagnosed mHSPC tested a response-adapted strategy using PSMA PET/CT to guide consolidative therapy after three cycles of apalutamide plus castration. After baseline and post-cycle-3 PSMA PET/CT, patients with ≤10 PSMA-avid metastases received radical prostatectomy or radiotherapy with SBRT to all lesions, while those with >10 continued apalutamide; the primary endpoint was undetectable PSA (≤0.2 ng/mL) after six cycles. Among 48 patients (median baseline PSA 56.8 ng/mL), the undetectable PSA rate at six cycles was 95.8% (46/48; 95% CI 86.0%–98.8%), up from 66.7% (32/48) after three cycles; grade ≥3 rash occurred in 4.2% (2/48). Site-specific responses favored distant lymph nodes (93.3%, 140/150) over vertebral/pelvic bone (78.5%, 255/325) and other bone (50.0%, 58/116; p<0.0001), supporting high PSA responses and manageable toxicity with PSMA-guided consolidative therapy plus intensified systemic treatment.
10.1007/s00259-026-07982-4
Jun 01 – Jun 08, 2026
Multimodal Artificial Intelligence Prediction of Abiraterone Efficacy in Two STAMPEDE Phase 3 Trials of Non-Metastatic Very High-Risk Prostate Cancer.
ANN ONCOL · Q1 JOURNAL - RANK #4/326TOP-TIER
The study investigated the efficacy of a multimodal artificial intelligence (MMAI) prediction model in stratifying abiraterone benefit among non-metastatic, clinically very high-risk prostate cancer patients within two STAMPEDE Phase 3 trials. Using a post-hoc analysis, data from 1,137 patients randomized to long-term androgen deprivation therapy (LT-ADT; N=583) or LT-ADT with abiraterone (N=554) were analyzed. Results demonstrated improved 5-year metastasis-free survival (MFS) in MMAI very high-risk patients treated with abiraterone (HR 0.47; 95% CI 0.31-0.70), increasing MFS from 62% to 81%, while the standard risk group showed minimal abiraterone benefit (interaction p=0.02). The study concludes that the MMAI model could be used clinically to predict abiraterone benefit and avoid unnecessary treatment-related toxicity in high-risk patients.
10.1016/j.annonc.2026.05.708
Phase 1b trial of Bavdegalutamide (ARV-110) in combination with Abiraterone for metastatic prostate cancer.
CLIN CANCER RES · Q1 JOURNAL - RANK #29/326TOP-TIER
This phase 1b clinical trial assessed the safety, tolerability, pharmacokinetics, and efficacy of bavdegalutamide in combination with abiraterone in 45 patients with metastatic prostate cancer experiencing PSA progression on abiraterone. Participants received bavdegalutamide 420 mg, abiraterone ≤1000 mg, and corticosteroids daily, with key outcomes including no observed dose-limiting toxicities, a PSA control rate of 48.9% (95% CI, 33.7–64.2), and a median radiographic progression-free survival of 16.3 months (95% CI, 8.2–not calculable). Most treatment-emergent adverse events (TEAEs; 82.2%) were grades 1/2, with fatigue (48.9%) and nausea (46.7%) being the most common drug-related effects. The study concluded that the regimen has a manageable safety profile, no significant drug-drug interaction, and demonstrated preliminary evidence of clinical activity in patients with mPC, including those with AR mutations.
10.1158/1078-0432.CCR-26-0253
Perioperative Apalutamide in High-Risk Localized Prostate Cancer.
NEW ENGL J MED · Q1 JOURNAL - RANK #2/332TOP-TIER
This phase 3, double-blind, placebo-controlled trial evaluated perioperative apalutamide plus androgen-deprivation therapy (ADT) in 2109 patients with high-risk localized prostate cancer undergoing radical prostatectomy. Patients were randomized 1:1 to ADT plus apalutamide (240 mg/day) or ADT plus placebo for 6 cycles before and after surgery. Pathological complete response or minimal residual disease was significantly higher with apalutamide (8.9% vs. 1.0%; OR, 10.17; P<0.001), and 5-year metastasis-free survival was improved (78.2% vs. 73.5%; HR, 0.80; P=0.02). The authors conclude that perioperative ADT plus apalutamide improves oncologic outcomes over ADT plus placebo, albeit with more adverse events.
10.1056/NEJMoa2603878
Aglatimagene besadenovec (CAN-2409) with radiotherapy for patients with localised prostate cancer: a phase 3, multicentre, randomised, double-blind, placebo-controlled trial.
LANCET ONCOL · Q1 JOURNAL - RANK #8/326TOP-TIER
This phase 3, randomised, double-blind, placebo-controlled trial evaluated whether aglatimagene besadenovec (CAN-2409) with valacyclovir and external beam radiation therapy (EBRT) improves disease-free survival in patients with localised prostate cancer. Conducted across 51 centers, 745 men aged ≥18 were randomized (2:1) to receive aglatimagene or placebo alongside EBRT and optional androgen deprivation therapy (ADT). After a median follow-up of 50.3 months, the aglatimagene group had a significantly longer median disease-free survival (not reached, 95% CI 121.78–NR) compared to placebo (86.1 months, IQR 29.7–143.0; HR 0.70; p=0.016) without substantially increased severe treatment-related adverse events. The study concluded that aglatimagene with valacyclovir offers clinically meaningful benefits in prolonging disease-free survival without a significant rise in serious toxicity for this patient population.
10.1016/S1470-2045(26)00071-9
PARP and Androgen-Signaling Inhibition plus ADT in Metastatic Prostate Cancer.
NEW ENGL J MED · Q1 JOURNAL - RANK #2/332TOP-TIER
This phase 3, double-blind trial evaluated the efficacy of talazoparib plus enzalutamide versus placebo plus enzalutamide in 599 patients with metastatic androgen pathway modulation-sensitive prostate cancer harboring homologous recombination repair gene alterations. Patients were randomized 1:1, stratified by disease status, volume, and mutation status, with primary and secondary endpoints of imaging-based progression-free survival (PFS) and overall survival (OS), respectively. At 3 years, PFS was 77% in the talazoparib group versus 56% in the control group (HR 0.48; 95% CI, 0.36-0.65; P<0.001), while OS was 78% versus 72% (HR 0.77; 95% CI, 0.56-1.04). The study concluded that talazoparib significantly improved PFS but was associated with higher rates of serious adverse events (42% vs. 32%), including grade 3+ anemia (51%).
10.1056/NEJMoa2604126
May 18 – May 25, 2026
Testosterone and docetaxel treatment effect on mortality risk in nonmetastatic high-risk prostate cancer: A predictive biomarker analysis.
CANCER-AM CANCER SOC · Q1 JOURNAL - RANK #68/326
This study assessed whether baseline testosterone modifies the mortality benefit of adding docetaxel to radiation therapy (RT) and androgen deprivation therapy (ADT) in nonmetastatic high-risk prostate cancer, using post-hoc analyses of two randomized trials. A discovery cohort (n=255; median age 65; median follow-up 10.4 years) and a validation cohort (n=563; median age 66; median follow-up 10.6 years) were analyzed with multivariable Cox models including a treatment-by-testosterone interaction and adjustments for age, T category, Gleason score, PSA, percent positive cores, and performance status. Randomization to RT+ADT+docetaxel significantly reduced all-cause mortality in patients with normal, but not low, testosterone, with significant interactions in both cohorts (p=0.048; p=0.042); benefit was most evident with PSA >20 ng/mL, T3/4 disease, or Gleason 9/10. The authors conclude normal testosterone predicts mortality reduction from adding docetaxel, supporting testosterone group as a predictive biomarker.
10.1002/cncr.70469