✦ Cancer Clinical Trials

Use the left sidebar to navigate between cancer topics.

Story

Prostate Cancer

If it’s your first time on this website, please read the disclaimer section.

Jun 01 – Jun 08, 2026

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

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

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

May 11 – May 18, 2026

OLIGOPELVIS 2-GETUG P12- elective nodal radiotherapy for oligorecurrent pelvic/para-aortic nodes in prostate cancer: early toxicity of a randomized phase 3 trial.
RADIOTHER ONCOL · Q1 JOURNAL - RANK #22/212
This prospective, multicenter, randomized phase III clinical trial (OLIGOPELVIS-2/GETUG P12) evaluated early toxicity at 18 months of salvage elective nodal radiotherapy (ENRT) combined with intermittent androgen deprivation therapy (iADT) versus iADT alone in 256 patients with pelvic and para-aortic oligometastatic prostate cancer. Patients were randomized: Arm A received 6-month iADT, and Arm B received 6-month iADT plus ENRT (54 Gy pelvic, 66 Gy pathological nodes), with 121 patients analyzed in Arm B and 127 in Arm A. At 6 months, grade ≥2 genitourinary (GU) toxicity was higher in Arm B (9.9%) than Arm A (2.4%, p=0.02), and gastrointestinal (GI) toxicity was 19.8% in Arm B versus 0% in Arm A (p<0.001); at 18 months, GU toxicity remained higher in Arm B (10.7% vs 4.1%, p=0.04) with no difference in GI toxicity. The study concludes that the addition of ENRT to iADT is associated with acceptable toxicity profiles, even for those with prior irradiation or additional para-aortic fields.
10.1016/j.radonc.2026.111533

Pelvic nodes ultra-hypo fractionated versus conventionally fractionated IMRT with HDR brachytherapy in prostate cancer: interim analysis of a collaborative multi-institutional non-inferiority phase 3 trial (PCS-XI, NCT05820633).
RADIOTHER ONCOL · Q1 JOURNAL - RANK #22/212
This phase 3 randomized controlled trial (PCS-XI) compared pelvic ultra-hypofractionated (UHF) versus conventionally fractionated (CF) radiotherapy with high-dose-rate brachytherapy and androgen deprivation therapy in intermediate to very-high-risk prostate cancer. Patients were randomized 1:1 to CF (43-46 Gy in 20-23 fractions) or UHF (25 Gy in 5 fractions) whole pelvic IMRT plus 15 Gy HDR-BT. At interim analysis of 142 patients (median follow-up 17.6 months), grade 2-3 genitourinary and gastrointestinal toxicity rates were low and comparable between arms, with no grade 4-5 toxicities. Clinically meaningful differences favored UHF for urinary incontinence at 12 months and bowel function at 18 months, while CF showed superior early hormonal function; longer follow-up is needed to assess oncologic outcomes and prove non-inferiority.
10.1016/j.radonc.2026.111598

Detection of Homologous Recombination Repair Gene Mutations by Tumor Tissue and Circulating Tumor DNA Testing in Prostate Cancer in the Phase III PROpel Trial.
JCO PRECIS ONCOL · Q1 JOURNAL - RANK #57/326
This Phase III PROpel trial investigated biomarker detection in first-line metastatic castration-resistant prostate cancer, where patients were randomized 1:1 to olaparib (300 mg BID) plus abiraterone versus placebo plus abiraterone with prednisone/prednisolone. Exploratory analyses assessed homologous recombination repair mutation (HRRm) and BRCA mutation (BRCAm) status using FoundationOne CDx (tumor tissue) and FoundationOne Liquid CDx (ctDNA), analyzed individually and in aggregate. HRRm status was obtained for 778/796 (98%) patients; 226 were HRRm-positive (including 85 BRCAm). In matched samples (n=491), concordance was high for HRRm (overall percent agreement 85.1%; NPV 93.7%) and BRCAm (OPA 93.9%; NPV 97.3%), with low ctDNA fraction causing rare discordance; aggregating tests maximized known biomarker status while limiting false negatives (estimated 1% unidentified BRCAm among 693 aggregated non-BRCAm).
10.1200/PO-25-01109

Testosterone Treatment in Prostate Cancer Survivors With Hypogonadism: A Randomized Clinical Trial.
JAMA INTERN MED · Q1 JOURNAL - RANK #7/332TOP-TIER
This randomized, double-blind, placebo-controlled phase 2 clinical trial evaluated the short-term safety and efficacy of testosterone replacement therapy (TRT) in 136 prostate cancer survivors with hypogonadism post-radical prostatectomy at two academic centers. Participants were allocated using concealed block randomization and received weekly intramuscular testosterone cypionate (100 mg) or placebo for 12 weeks, with primary outcomes being sexual activity and safety (biochemical recurrence). TRT significantly increased daily sexual activity (between-group difference 0.91 daily events [95% CI, 0.56-1.26], P < .001), sexual desire, and quality-of-life sexual domain, while improving body composition and aerobic capacity; no biochemical recurrence occurred in either arm. The study concludes TRT improves sexual and physical outcomes without biochemical recurrence risk in this specific population, but was not powered for long-term safety or clinical recurrence.
10.1001/jamainternmed.2026.1343

Phase 2 study of talabostat, a small molecule inhibitor of dipeptidyl peptidases (DPP), administered in combination with pembrolizumab in patients with small cell neuroendocrine prostate cancer.
J IMMUNOTHER CANCER · Q1 JOURNAL - RANK #12/183TOP-TIER
This phase 2 prospective clinical trial evaluated the combination of talabostat and pembrolizumab in 34 patients with small cell neuroendocrine prostate cancer (SCNC) who had progression after at least one prior systemic therapy. Patients received pembrolizumab intravenously every 21 days plus escalating oral doses of BXCL701 (talabostat), with response and biomarker analysis as endpoints. In the evaluable subset (n=30), composite response rate was 20% (95% CI 7.7%-38.6%), objective response rate was 13% (95% CI 3.8%-30.7%), median response duration was 9.0 months, median progression-free survival was 2.1 months, and median overall survival was 13.7 months. The study concluded that talabostat plus pembrolizumab showed preliminary anti-tumor activity, with baseline DPP9 stromal expression linked to response, warranting further randomized investigation.
10.1136/jitc-2025-014242

May 04 – May 11, 2026

10-yr Survival and Toxicity Outcomes of Stereotactic Body Radiotherapy for Prostate Cancer: A Nonrandomized Clinical Trial.
EUR UROL · Q1 JOURNAL - RANK #3/133TOP-TIER
This multi-institutional, nonrandomized clinical trial prospectively evaluated stereotactic body radiotherapy (SBRT) for organ-confined prostate cancer in 310 patients (172 low-risk, 138 intermediate-risk) treated from 2008 to 2010, with a median follow-up of 9 years. The methodology involved active SBRT treatment, excluding adjuvant hormone therapy, and toxicity assessment was conducted using CTCAE v3 (>90 days post-treatment). Key findings include 10-year cumulative grade 3 gastrointestinal and genitourinary toxicities of 1.4% and 1.5% respectively, grade 2+ GI and GU toxicity rates of 2.1% and 14%, 84% overall survival, and 90% relapse-free survival (RFS) overall. The principal conclusion is that prostate SBRT achieves high long-term survival and minimal toxicity in both low- and intermediate-risk cohorts.
10.1016/j.eururo.2026.04.029

Nivolumab plus ipilimumab for chemotherapy-refractory metastatic castration-resistant prostate cancer: results from the randomized portion of the phase 2 CheckMate 650 trial.
NAT COMMUN · Q1 JOURNAL - RANK #10/135TOP-TIER
This randomized, open-label phase 2 clinical trial (CheckMate 650) evaluated efficacy and safety of nivolumab plus ipilimumab versus ipilimumab alone and cabazitaxel in docetaxel-experienced, chemotherapy-refractory metastatic castration-resistant prostate cancer patients. Patients (n=259) were randomized to four regimens, and primary endpoints were objective response rate (ORR) and radiographic progression-free survival (rPFS); ORRs ranged from 4.5% to 19.5% and median rPFS from 3.5 to 7.9 months. Incidence of grade ≥3 treatment-related adverse events ranged from 18.4% to 34.7%. The trial suggests antitumor activity with nivolumab plus ipilimumab and nominates a candidate biomarker associated with prolonged overall survival, recommending its validation in future studies.
10.1038/s41467-026-72242-w

Multicenter, Randomized, Phase II Trial of Olaparib Plus Radium-223 Versus Radium-223 in Men With Castration-Resistant Prostate Cancer With Bone Metastases (COMRADE).
J CLIN ONCOL · Q1 JOURNAL - RANK #6/326TOP-TIER
This multicenter, randomized, open-label phase II trial evaluated whether adding olaparib to radium-223 improves outcomes in men with metastatic castration-resistant prostate cancer (mCRPC) with ≥2 bone metastases. One hundred twenty patients were randomized 1:1 to olaparib (200 mg twice daily) plus radium-223 (55 kBq/kg q4wk ×6) versus radium-223 alone; crossover at progression was allowed, and the primary endpoint was investigator-assessed radiographic progression-free survival (rPFS). Combination therapy significantly prolonged rPFS (median 8.9 vs 4.7 months; HR 0.50, one-sided 90% CI 0.35–0.70; one-sided p=0.0042), with larger effects in those without prior docetaxel (13.7 vs 5.7 months; HR 0.24, 90% CI 0.15–0.40) and with ≤20 bone metastases (13.4 vs 4.2 months; HR 0.21, 90% CI 0.13–0.33); 1-year symptomatic skeletal-related events were 12.7% vs 22.9%, and overall survival was similar (20.2 vs 21.1 months). Grade ≥3 treatment-related adverse events were higher with the combination (56% vs 33%), mainly hematologic (lymphopenia 31% vs 9.1%, anemia 22% vs 16%, thrombocytopenia 6.8% vs 3.6%), supporting further exploration of DNA damage–targeted strategies.
10.1200/JCO-25-02835

Outcome and Safety of Radioligand Therapy With [ 161 Tb]Tb-PSMA-617 After Re-Progression in mCRPC Patients Previously Treated With [ 177 Lu]Lu-PSMA-617.
CLIN NUCL MED · Q1 JOURNAL - RANK #6/212
This prospective single-arm study aimed to assess the efficacy and safety of [161Tb]Tb-PSMA-617 RLT in 15 patients with mCRPC who progressed after [177Lu]Lu-PSMA-617 therapy. Patients received a median of 3 cycles (range: 2–7) with a mean administered activity of 5.4 ± 1.1 GBq per cycle, tracked in a prospective registry (NCT04833517). Response rates were 66.7% (biochemical) and 86.7% (molecular imaging), with a median PFS of 6.4 months and OS of 15.5 months. No treatment discontinuations and few severe adverse events suggest that [161Tb]Tb-PSMA-617 RLT is an effective and well-tolerated second-line therapy in this population.
10.1097/RLU.0000000000006384

Phase II trial of combination radiation, hormone, and immunotherapy in grade group 5 prostate cancer.
J IMMUNOTHER CANCER · Q1 JOURNAL - RANK #12/183TOP-TIER
This non-randomized phase II trial tested adding nivolumab to standard androgen deprivation therapy (ADT), high-dose rate brachytherapy (HDRBT), and external beam radiation in 31 patients with localized or oligometastatic grade group 5 prostate cancer with >30% positive biopsy cores. Nivolumab 240 mg every 2 weeks for four doses began 4 weeks before HDRBT; the primary endpoint was whether the 2-year freedom from biochemical recurrence (FFBR) exceeded a 75% historical control. With a median follow-up of 38.8 months (IQR 31.0–46.5), the 2-year FFBR was 90.3% (95% CI 74.3–98.0; one-sided p=0.024), median FFBR not reached; acute grade 2 and grade 3 adverse events were each 6.3%, with no grade ≥4. A higher Decipher immunosuppression score correlated with early pathologic response (p=0.005) and time to metastatic failure (p=0.044), supporting further randomized evaluation.
10.1136/jitc-2025-013906

Pembrolizumab Plus Lenvatinib in Participants with Docetaxel-pretreated Metastatic Castration-resistant Prostate Cancer: Results from KEYNOTE-365 Cohort E.
EUR UROL ONCOL · Q1 JOURNAL - RANK #7/133
This phase 1b/2, open-label KEYNOTE-365 cohort E clinical trial evaluated pembrolizumab 200 mg every 3 weeks plus continuous oral lenvatinib 20 mg in 39 adults with metastatic castration-resistant prostate cancer previously treated with docetaxel. Participants (ECOG 0–1) were followed a median of 9.7 months; primary endpoints were PSA response rate, RECIST v1.1 objective response rate by blinded central review, and safety. Confirmed PSA response was achieved in 34 % (95 % CI 20–51) of all patients, and ORR in RECIST-measurable disease was 36 % (95 % CI 18–57); 92 % experienced treatment-related adverse events and 62 % had grade 3–5 events, with two non-treatment-related deaths. The study concludes that pembrolizumab plus lenvatinib shows encouraging antitumor activity with a manageable but substantial toxicity profile in docetaxel-pretreated mCRPC.
10.1016/j.euo.2026.03.026

Apr 27 – May 04, 2026

Salvage High-intensity Focused Ultrasound for Prostate Cancer Recurrence after Radiotherapy (HIFI-2 Study).
EUR UROL ONCOL · Q1 JOURNAL - RANK #7/133
This prospective, nationwide study in 32 French centers explored salvage high-intensity focused ultrasound (S-HIFU) for biopsy-confirmed intraprostatic recurrence in 531 patients after radiotherapy. The primary endpoint was 30-month androgen deprivation therapy-free survival (ADT-FS), at 71% (95% CI, 67-76) overall and 84% (95% CI, 78-91) for PSA ≤ 4.5 ng/ml. High-grade (>IIIa) complications occurred in 19 of 531 patients, with severe incontinence rising from 7% to 12%. These findings highlight S-HIFU as a valuable salvage option with minimal quality-of-life impact, warranting further comparative research.
10.1016/j.euo.2026.04.007

Safety and efficacy of moderately hypofractionated radiotherapy after radical prostatectomy: A phase II trial.
RADIOTHER ONCOL · Q1 JOURNAL - RANK #22/212
This single-arm phase II trial assessed the safety and efficacy of moderately hypofractionated radiotherapy (54 Gy in 18 fractions) after radical prostatectomy in 55 prostate cancer patients, with 89% receiving salvage RT and 11% adjuvant RT. Primary outcomes included grade ≥2 acute GU (5.5%) and GI (34.5%) toxicities, with 3-year biochemical recurrence-free survival at 65.8% (95% CI: 51.1-77.1). Late grade ≥2 GU and GI toxicities occurred in 14.6% and 21.8% of patients, respectively, with transient QoL impacts. The study concluded that this regimen offers favorable biochemical control and manageable toxicity, supporting its clinical feasibility.
10.1016/j.radonc.2026.111549

Apr 20 – Apr 27, 2026

Phase 2 trial of pTVG-HP ± pTVG-AR DNA vaccines and pembrolizumab in patients with metastatic, castration-resistant prostate cancer (mCRPC).
J IMMUNOTHER CANCER · Q1 JOURNAL - RANK #12/183TOP-TIER
This prospective Phase 2 trial tested the addition of a second DNA vaccine (pTVG-AR) to broaden T-cell responses in patients with metastatic castration-resistant prostate cancer receiving pembrolizumab. Sixty patients were randomized to receive pTVG-HP alone (Arm A) or alternating pTVG-HP/pTVG-AR (Arm B) in cycles, then pembrolizumab with optional booster immunizations at PSA progression. At 6 months, PFS was 51% in Arm A vs 45% in Arm B, partial responses were observed in 30% of those with measurable disease, and median OS was 2.8 years overall. This study concluded that the dual vaccine approach was safe and induced immune responses, but did not yield significantly superior efficacy compared to pTVG-HP alone.
10.1136/jitc-2025-014323

Apr 13 – Apr 20, 2026

Phase I dose-escalation study of [¹⁷⁷Lu]Lu-LNC1011, a long-circulating dansyl-modified PSMA theranostics, in metastatic castration-resistant prostate cancer.
THERANOSTICS · Q1 JOURNAL - RANK #7/195TOP-TIER
This open-label, non-randomized Phase I dose-escalation clinical trial evaluated the safety, dosimetry, and preliminary efficacy of [177Lu]Lu-LNC1011 in mCRPC patients with PSMA-positive lesions on PET/CT, enrolling nine patients across 1.85, 2.78, and 3.70 GBq dose levels. No dose-limiting toxicities occurred, with an effective whole-body dose of 0.13 ± 0.019 mSv/MBq; organ absorbed doses included kidneys 3.33 ± 1.09 Gy/GBq, salivary glands 1.70 ± 1.04 Gy/GBq, red marrow 0.11 ± 0.03 Gy/GBq, and tumors 12.29 ± 6.50 Gy/GBq, and effective half-lives of 49.44 ± 12.58 h (whole body) and 128.3 ± 62.79 h (tumors). After two treatment cycles, the 3.70 GBq cohort (n = 3) showed PSA reductions in 3/3 (with ≥50% decline in 2/3) and RECIP 1.0 responses of partial response in 2/3 and stable disease in 1/3. The study concludes [177Lu]Lu-LNC1011 was well tolerated with high tumor dose and prolonged retention, supporting further multi-cycle evaluation at 3.70 GBq per cycle.
10.7150/thno.128143

Rezvilutamide plus docetaxel in chemotherapy-naive metastatic castration-resistant prostate cancer patients after progression on abiraterone: A multi-centre, open-label, phase II trial.
CLIN TRANSL MED · Q1 JOURNAL - RANK #47/326
This multi-centre, open-label phase II trial prospectively evaluated the addition of the androgen-receptor antagonist rezvilutamide to standard docetaxel in 36 chemotherapy-naive patients with metastatic castration-resistant prostate cancer who had progressed on abiraterone. Patients received rezvilutamide 160 mg or 240 mg orally once daily plus docetaxel 75 mg/m² every three weeks for up to 10 cycles, followed by rezvilutamide 240 mg monotherapy; safety was the primary endpoint and efficacy endpoints included PSA response and survival outcomes. No dose-limiting toxicities occurred, although 32/36 (88.9 %) experienced grade ≥3 treatment-related adverse events; at week 12, 21/31 evaluable patients (67.7 %) achieved a PSA response. Median PSA progression time was 10.5 months (95 % CI 5.6–14.1), radiological progression-free survival 13.8 months (95 % CI 8.4–19.2), and overall survival 16.2 months (95 % CI 12.9–22.5), indicating promising efficacy in this setting.
10.1002/ctm2.70649

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.
LANCET ONCOL · Q1 JOURNAL - RANK #8/326TOP-TIER
This was a prospective, randomized, double-blind, placebo-controlled, phase 3 trial evaluating darolutamide plus androgen deprivation therapy (ADT) in men with metastatic hormone-sensitive prostate cancer. The primary objective was to determine radiological progression-free survival, and key findings included a hazard ratio of 0.72 (95% CI 0.54-0.96) for time to pain progression and 0.76 (95% CI 0.61-0.94) for time to deterioration in overall wellbeing. The most common grade 3-4 adverse events were hypertension, anemia, and increased aspartate aminotransferase. The investigators concluded that darolutamide plus ADT delays pain progression and preserves quality of life, supporting it as a standard-of-care option.
10.1016/S1470-2045(26)00014-8

Efficacy and safety of darolutamide in combination with androgen deprivation therapy and docetaxel in European patients from the phase 3 ARASENS trial.
EUR J CANCER · Q1 JOURNAL - RANK #45/326
This prospective phase 3 clinical trial evaluated the efficacy and safety of darolutamide combined with androgen deprivation therapy and docetaxel versus placebo plus ADT and docetaxel in European patients with metastatic hormone-sensitive prostate cancer. Patients were randomized 1:1 to receive darolutamide 600 mg twice daily or placebo, with the primary endpoint being overall survival and secondary endpoints including time to metastatic castration-resistant prostate cancer, pain progression, symptomatic skeletal events, and subsequent therapy initiation. Darolutamide reduced the risk of death by 37% (HR 0.63, 95% CI 0.48-0.83), delayed all secondary endpoints, and showed a lower incidence of serious treatment-emergent adverse events compared to placebo (37.9% vs. 43.1%). The study concluded that darolutamide improved survival outcomes and was well-tolerated in European patients, with findings consistent with the overall trial population.
10.1016/j.ejca.2026.116730

Deutenzalutamide, a novel androgen receptor inhibitor, after progression on docetaxel and abiraterone in metastatic castration-resistant prostate cancer: results from the randomized phase III HC-1119-04 trial.
SIGNAL TRANSDUCT TAR · Q1 JOURNAL - RANK #1/319TOP-TIER
This randomized, double-blind, phase III trial compared deutenzalutamide 80 mg once daily versus placebo in men with metastatic castration-resistant prostate cancer who had progressed on or were intolerant to abiraterone and docetaxel or were ineligible for docetaxel, conducted across 36 centers in China with 417 patients (276 deutenzalutamide; 141 placebo) and radiographic progression-free survival (rPFS) as the primary endpoint. Deutenzalutamide significantly improved rPFS versus placebo (HR 0.58; P=0.0001), while the initial overall survival (OS) analysis was not significant (HR 0.95) but became favorable after adjustment for subsequent therapies (HR 0.65–0.73). Safety showed treatment-related grade ≥3 adverse events in 22.3% with deutenzalutamide versus 15.0% with placebo, with anemia the most common event (any grade 21.2% vs 17.9%; grade 3/4 6.6% vs 2.9%); no seizures or falls were reported. The study concludes that deutenzalutamide prolongs rPFS and may improve OS after adjustment, with a favorable safety profile, supporting its use as a new option for post-abiraterone mCRPC.
10.1038/s41392-026-02618-3

Apr 06 – Apr 13, 2026

Associations Between Quality of Life and Disease Progression in Metastatic Hormone-sensitive Prostate Cancer: Insights from ARASENS and ARANOTE Trials.
EUR UROL ONCOL · Q1 JOURNAL - RANK #7/133
This analysis investigated longitudinal quality-of-life (QoL) trajectories in metastatic hormone-sensitive prostate cancer by pooling data from two randomized, prospective, phase III clinical trials (ARASENS and ARANOTE). Both trials tested androgen deprivation therapy (ADT) combined with other treatments ± darolutamide and measured QoL using NCCN-FACT FPSI-17 or FACT-P. Darolutamide treatment was associated with higher QoL, and QoL decline was significantly linked to increased progression risk (CROD HR 2.58 [1.76–3.78]; rPFS HR 1.32 [1.00–1.75]). The authors concluded that preservation of QoL contributed partially to darolutamide’s benefit and that early QoL monitoring may serve as an indicator of impending disease progression.
10.1016/j.euo.2026.03.009

The anti-obesogenic metabolite, Lac-Phe, is elevated by metformin treatment in prostate cancer patients.
EMBO MOL MED · Q1 JOURNAL - RANK #21/195
The study aimed to investigate whether the anti-obesogenic metabolite Lac-Phe, elevated by metformin in Type 2 diabetic patients, also increases in prostate cancer patients treated with metformin, using data from the prospective BIMET-1 trial. Serum Lac-Phe levels were profiled in non-diabetic prostate cancer patients, showing that metformin treatment significantly increased Lac-Phe concentrations to levels comparable to those after strenuous exercise, regardless of disease stage, anticancer outcomes, or hormone therapy status. Patients on metformin also exhibited improved weight management post anti-androgen therapy compared to controls. The study concludes that the metformin/Lac-Phe axis provides a molecular basis for the metabolic benefits of metformin repurposing in cancer patients.
10.1038/s44321-026-00408-6