Cancer clinical trial database.
Every new trial and trial result from New in Oncology, our weekly research briefing, since the first issue on . Search by NCT number, drug, or cancer type.
All entries in prostate cancer
- New trial
Prostate cancer
Phase II trial of JSB462 (novel androgen receptor antagonist) plus abiraterone in metastatic prostate cancer
This randomized, open-label, multi-center study by Novartis evaluates safety, efficacy, and pharmacokinetics of two JSB462 dosing regimens combined with standard abiraterone versus standard ARPIs in adult males with…
NCT06991556 Exploratory - New trial
Prostate cancer
Phase II Tumor-Focused Radiotherapy: Image-Guided Brachytherapy Radiation Device Targeting Prostate Cancer
The University of California, San Diego is conducting a phase II randomized trial comparing standard whole-prostate radiotherapy with investigational image-guided tumor-focused radiotherapy using a brachytherapy…
NCT06990542 Exploratory - New trial
Prostate cancer
Phase 1 Pilot: 225Ac-PSMA-617 alpha-emitter targeting PSMA in prostate cancer
This single-center pilot study compares 177Lu-PSMA-617 and 225Ac-PSMA-617 radioligand therapies administered via IV or intra-arterial routes in patients with localized high-risk prostate cancer scheduled for…
NCT07054346 Exploratory - Trial result
Prostate cancer
6-mo Triple AR Blockade + Metastasis-Directed RT Yields 83% Deep PSA Response in Synchronous PSMA-PET Oligometastatic Prostate Cancer
In a pooled post-hoc look at the Phase 2 SOLAR (NCT03298087) and SATURN (NCT03902951) trials, 50 PSMA-PET-defined castrate-sensitive oligometastatic patients (≤5 lesions) received 6 months of leuprolide, abiraterone…
NCT03298087 - New trial Spotlight
Prostate cancer
Phase 3 trial of Mevrometostat, an EZH2 inhibitor, with Enzalutamide in metastatic castration-sensitive prostate cancer
This randomized trial evaluates whether combining investigational Mevrometostat with enzalutamide improves outcomes for ARPI-naïve, chemo-naïve metastatic castration-sensitive prostate cancer patients compared to…
NCT07028853 Registrational - New trial
Prostate cancer
Phase 1b 177Lu-PSMA-617, PSMA directed beta emitter for mCRPC
This single-arm study at MD Anderson evaluates Lu-PSMA-617, administered IV every six weeks, for men with metastatic castration-resistant prostate cancer, PSA rise, bone marrow involvement, and cytopenia after…
NCT07025512 Exploratory - New trial
Prostate cancer
Phase 3 64Cu-SAR-bisPSMA PSMA-targeted imaging agent for recurrent prostate cancer
This study evaluates 64Cu-SAR-bisPSMA PET/CT for detecting prostate cancer recurrence in patients with prior prostatectomy, radiation, cryotherapy, or brachytherapy. Sponsored by Clarity Pharmaceuticals in Omaha, it…
NCT06970847 Registrational - New trial
Prostate cancer
Phase II: Darolutamide, Androgen Receptor Inhibitor in Prostate Cancer Neoadjuvant Study
This single-arm phase II trial by Icahn School of Medicine at Mount Sinai evaluates neoadjuvant ADT with leuprolide, darolutamide, and pembrolizumab followed by adjuvant pembrolizumab in NCCN high-risk non-metastatic…
NCT07027124 Exploratory - New trial
Prostate cancer
Phase 2 trial of relugolix, a GnRH receptor inhibitor improving PSMA PET/CT sensitivity.
This Phase 2 randomized study by Mayo Clinic evaluates short-course relugolix (administered for 5, 10, or 15 days) to boost PSMA expression and enhance PET/CT imaging in high/very high risk prostate cancer patients…
NCT07025369 Exploratory - New trial
Prostate cancer
Phase II Trial: 177Lu Vipivotide Tetraxetan, PSMA-Directed Beta Emitter
This Phase II study randomizes men with PSMA-positive metastatic castration-resistant prostate cancer who progressed on prior ARPI to receive 6 cycles of 177Lu Vipivotide Tetraxetan either in combination with an…
NCT06894511 Exploratory - New trial
Prostate cancer
Phase 1 study of STM-416p, a resiquimod TLR7/8 activator
This study evaluates the safety and optimal dosing of intraoperative STM-416p in men with Grade group 2–5 prostate cancer undergoing radical prostatectomy. Conducted at Tucson and Gainesville sites, the trial is…
NCT06450106 First-in-human - Trial result
Prostate cancer
Gotistobart (pH-sensitive anti-CTLA-4) + 177Lu-PSMA-617 logs 67% PSA50 with no DLTs in dose-escalation mCRPC
Gotistobart, a recycling-preserving CTLA-4 antibody that selectively depletes intratumoral Tregs, was paired with standard Lu 177 vipivotide tetraxetan radioligand therapy in the PRESERVE-006 Phase 1 dose-escalation…
NCT05682443 - New trial
Prostate cancer
Phase 2 CT-SBRT, image-guided precision radiotherapy for localized prostate cancer.
This trial evaluates CT-guided SBRT with intrafraction motion monitoring delivered over five fractions in patients with localized prostate cancer. The study assesses treatment efficacy and side effects while…
NCT06995053 - Trial result
Prostate cancer
Abiraterone Without Ongoing GnRH Holds Testosterone Down and Delivers 27-Month PFS in Metastatic Prostate Cancer
Abiraterone, a CYP17 inhibitor that is approved for prostate cancer, + prednisone was given to 31 men with metastatic prostate cancer after stopping their GnRH analogue in this single-arm Phase II study…
NCT03565835 - Trial result
Prostate cancer
HSV- Thymidine-Kinase Gene Therapy CAN-2409 + Valacyclovir Cuts Recurrence 30% with EBRT in Localized Prostate Cancer
CAN-2409 is a replication-defective adenovirus delivering HSV-thymidine-kinase. When combined with oral valacyclovir, CAN-2409 triggers immunogenic cell death. In the double-blind Phase 3 trial NCT01436968, 745…
NCT01436968 - Trial result
Prostate cancer
High PSMA PET Tumor Volume Halves 5-Year PFS in ENZAMET mHSPC Sub-Cohort
In an ENZAMET substudy, 100 patients received testosterone suppression with either enzalutamide or a control non-steroidal antiandrogen then underwent a semi-automated PSMA total tumor volume (TTV) quantified on…
- Trial result
Prostate cancer
Methylation-Based Tumor Fraction (ctDNA) Beats PSA for Predicting Rucaparib Outcomes in BRCA deficient mCRPC
In TRITON2 (NCT02952534), a Phase 2 study of rucaparib (an approved PARP inhibitor) in BRCA mutation deficient (germline and/or somatic) metastatic castration-resistant prostate cancer, a lower baseline plasma tumor…
NCT02952534 - Trial result
Prostate cancer
Rucaparib Boosts PFS Across Germline and Somatic BRCA-Mut mCRPC in TRITON3
Rucaparib, an oral PARP inhibitor, was compared with physician’s-choice docetaxel or abiraterone/enzalutamide in the Phase 3 TRITON3 trial (NCT02975934) in the ~13% of patients with BRCA deficient metastatic…
NCT02975934 - Trial result
Prostate cancer
Short-Course ADT + Apalutamide ± Abiraterone with SBRT Yields ≥85% 18-mo PFS in PSMA-PET Oligometastatic Prostate Cancer
In the randomized phase II Metacure B2 study (NCT03436654) and its expansion (n = 36), men with PSMA-PET-detected metachronous oligometastatic, hormone-sensitive prostate cancer received stereotactic body…
NCT03436654 - New trial
Prostate cancer
Phase 3 Study of Ifinatamab Deruxtecan (B7-H3 ADC) Versus Docetaxel in mCRPC
Merck is sponsoring this open-label study comparing ifinatamab deruxtecan—a B7-H3–directed antibody-drug conjugate with a Topo1 inhibitor payload—with standard docetaxel plus prednisone in patients with mCRPC…
NCT06925737 - New trial
Prostate cancer
Micro-US vs MRI in Active Surveillance for Detecting ≥GG2 Prostate Cancer
University of Alberta is conducting the MUSIC-AS trial to compare micro-ultrasound–guided biopsies (using the UTZ Imaging System) with MRI-guided methods in active surveillance of Gleason Grade Group 1 prostate…
NCT05558241 - New trial
Prostate cancer
Trial of 177Lu-PSMA-617 (Pluvicto) in PSMA-Positive mCRPC with Super Scan Bone Metastases
This study evaluates the safety, tolerability, and optimal dosing of Pluvicto—a PSMA-directed beta emitter radiation conjugate—in men with progressive metastatic castration-resistant prostate cancer (mCRPC)…
NCT06972628 - Trial result
Prostate cancer
DB-1311/BNT324 (B7-H3 ADC) logs 28% responses and 8-mo rPFS in late-line CRPC
In the Phase 1/2 dose-optimization study NCT05914116, 65 heavily pre-treated metastatic CRPC patients (median 3 prior lines; 94% docetaxel, 15% Lu-177) received 6 mg/kg or 9 mg/kg Q3W DB-1311/BNT324; among 43…
NCT05914116 - Trial result
Prostate cancer
Tb-161 PSMA-I&T (β + Auger RLT) achieves 70% PSA50 response in post-taxane mCRPC
In the single-arm Phase I/II VIOLET trial (NCT05521412), 30 PSMA-PET–positive mCRPC patients previously treated with taxane ± ARPI received up to six Q6W cycles of [^161Tb]Tb-PSMA-I&T (4.4-7.4 GBq; 3 + 3 escalation);…
NCT05521412 - Trial result
Prostate cancer
Rucaparib (PARP inhibitor) maintenance after platinum induction hits 17.7 mo rPFS in BRCA-C (BRCA1/2 or PALB altered) mCRPC
In the single-arm Phase 2 trial NCT02985021, 18 HRR-deficient mCRPC patients received four 21-day cycles of docetaxel 60 mg/m² + carboplatin AUC5, then continuous rucaparib 600 mg BID; overall median rPFS was 8.1 mo,…
NCT02985021 - Trial result
Prostate cancer
Olaparib ± abiraterone (PARP-1/2 inhibitor) slashes rPFS risk by ≈ 75% in BRCA-mut mCRPC
Phase 3 data compiled in a new review show that olaparib monotherapy in PROfound’s Cohort A (BRCA1/2 ± ATM; n = 162 vs 83) cut radiographic PFS by 78% vs physician-choice ARPI (HR 0.22) and improved OS (HR 0.63); in…
- Trial result
Prostate cancer
Fusion of Dose-Dense Docetaxel and Radium-223 Delivers Promise for Bone-Dominant CRPC
A phase escalation study in bone-predominant metastatic castration-resistant prostate cancer (CRPC) demonstrated that a dose-dense regimen of docetaxel combined with standard radium-223—with a lead-in cycle and G-CSF…
- New trial
Prostate cancer
BURN Study: Buffered Lidocaine in Reducing Pain From Prostate Biopsy
This phase I/II trial evaluates whether buffered lidocaine during prostate biopsy can reduce procedural pain compared to standard lidocaine. The study, focusing on resectable prostate cancer patients, is led by the…
NCT06661902 - New trial
Prostate cancer
Evaluation of Ultralow Dose PET Imaging for Detecting PSMA Expression
This study from Nuclear Imaging Institute is assessing an ultralow dose PET imaging technique using 18F-DCFPyL to detect prostate cancer with significantly reduced radiation exposure. Healthy volunteers and patients…
NCT06904313 - New trial
Prostate cancer
A Single-Arm, Blinded, Fluorescent PSMA Histopathology Trial of AS1986NS
Antelope Surgical Solutions is evaluating a single peripheral IV bolus dose of AS1986NS as a PSMA-directed fluorescent imaging agent for prostate cancer.
NCT06906471
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