Prostate Biopsy
ExactVu OPTIMUM: Optimization of Prostate Biopsy – Micro-Ultrasound versus MRI (OPTIMUM): A 3-arm randomized controlled trial evaluating the role of 29MHz micro-ultrasound in guiding prostate biopsy in men with clinical suspicion of prostate cancer (EVU-2021-001)
Phase: N/A
Study Product: Optimization of prostate biopsy- ExactVu (no MRI) vs Uronav vs ExactVu fusion with MRI- pts must enroll in study before getting MRI
Estimated Study Completion Date: December 2024
ClinicalTrials.gov Identifier: NCT05220501
Newly Diagnosed Prostate Cancer
Radical Prostatectomy
PROTEUS substudy: A Study of ERLEADA (Apalutamide) in Participants With High‑Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy
Phase: 3
Study Product: ADT + Apa- 6M before and after RP vs RP + SOC (1:3) (Gleason ≥8 or PSA ≥20)
Estimated Study Completion Date: April 7, 2027
ClinicalTrials.gov Identifier: NCT03767244
PSA Relapse
Vaccitech: A Phase 1/Phase 2 Trial to Evaluate Safety, Immunogenicity and PSA Response of VTP-850 Prostate Cancer Immunotherapeutic in Men With Biochemical Recurrence After Definitive Local Therapy for Prostate Cancer
Phase: 1/2
Study Product: VTP-850 (viral vector) prime-boost regimens with booster IM for BCR
Estimated Study Completion Date: April 2027
ClinicalTrials.gov Identifier: NCT05617040
Clarity SABRE: 64Cu-SAR-BBN Positron Emission Tomography: A Phase 2 Study of Participants with PSMA-negative Biochemical Recurrence of Prostate Cancer
Phase: 2
Study Product: 64Cu-SAR-BBN PET/CT- diagnostic study only
Estimated Study Completion Date: October 2023
ClinicalTrials.gov Identifier: NCT05407311
MCSPC
CAPItello-281: A Phase III Double-Blind, Randomised, Placebo-Controlled Study Assessing the Efficacy and Safety of Capivasertib + Abiraterone Versus Placebo + Abiraterone as Treatment for Patients with DeNovo Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) Characterised by PTEN deficiency (CAPItello-281)
Phase: 3
Study Product: Capivasertib plus abiraterone vs. placebo plus abiraterone
Estimated Study Completion Date: November 2025
ClinicalTrials.gov Identifier: NCT04493853
PSMAddition: An International Prospective Open-label, Randomized, Phase III Study Comparing 177Lu-PSMA-617 in Combination With Soc, Versus SoC Alone, in Adult Male Patients With mHSPC
Phase: 3
Study Product: 177Lu-PSMA-617 + SOC vs SOC Alone
Estimated Study Completion Date: December 18, 2025
ClinicalTrials.gov Identifier: NCT04720157
mCRPC
Post Abi and/or Enza in mCSPC or mCRPC setting
Propella: Open-Label, Multicenter Study of Intramuscular PRL-02 Depot in Patients with Advanced Prostate Cancer
Phase: 1
Study Product: – post Abi and/or Enza (4wk washout)- must have ADT ≥1 month and T 2-49 ng/dL- IM Abi depot + Pred
Estimated Study Completion Date: April 30, 2025
ClinicalTrials.gov Identifier: NCT04729114
Post Abi, Enza, Apa, and/or Daro (prior chemo allowed)
ARV-766: A Phase 1/2 Open-Label, Dose-Escalation and Cohort Expansion Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ARV-766 in Patients with Metastatic Castration-Resistant Prostate Cancer
Phase: 1/2
Study Product: post 1-3 ARTT for mCSPC/mCRPC (2 lines chemo allowed)- dose expansion oral ARV-766 (AR PROTAC)
Estimated Study Completion Date: June 27, 2025
ClinicalTrials.gov Identifier: NCT05067140
Post Doce
MK365: Phase Ib/II Trial of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (mCRPC) (KEYNOTE-365)
Phase: 1b/2
Study Product: Cohort E: Pembro + Lenvatinib; Cohort F: t-NE-Pembro + Lenvatinib; Cohort G: Pembro + Vibostolimab; Cohort H: t-NE-Pembro + Vibostolimab
Estimated Study Completion Date: May 30, 2025
ClinicalTrials.gov Identifier: NCT02861573
Exelixis Stellar-002 escalation: A Dose-Escalation and Expansion Study of the Safety and Efficacy of XL092 in Combination with Immuno-Oncology Agents in Subjects with Unresectable Advanced or Metastatic Solid Tumors
Phase: 1b
Study Product: life-prolonging therapies do not exist/are not available or are intolerable- cohort A: XL092 + Nivo vs cohort B: XL092 + Nivo + Ipi vs cohort D: XL092 + Nivo/Relatlimab (MD choice based on slots)
Estimated Study Completion Date: May 2026
ClinicalTrials.gov Identifier: NCT05176483
MacroGenics: A Phase 2/3, Randomized, Open-label, Study of MGC018 Versus Androgen Receptor Axis-targeted Therapy (Abiraterone or Enzalutamide) in Participants with Metastatic Castration-resistant Prostate Cancer
Phase: 2/3
Study Product: post Doce and post 1L ARTT- MGC018 2 mg/kg IV Q4W vs MGC018 2.7 mg/kg IV Q4W vs ARRT (1:1:1)
Estimated Study Completion Date: December 2026
ClinicalTrials.gov Identifier: NCT05551117
Progressing on Abi or Enza in mCSPC or CRPC setting
ARV-110: A Phase 1b Open-Label, Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of ARV-110 in Combination With Abiraterone in Patients With Metastatic Prostate Cancer
Phase: 1
Study Product: ARV-110 in Combination with Abiraterone
Estimated Study Completion Date: June 2024
ClinicalTrials.gov Identifier: NCT05177042
Post 1L ARTT in mCSPC or CRPC setting
C2321001: A Phase 1 Dose Escalation and Expanded Cohort Study Of PF-06821497 In The Treatment Of Adult Patients With Castration Resistant Prostate Cancer (CRPC)
Phase: 1
Study Product: PF-06821497
Estimated Study Completion Date: May 6, 2024
ClinicalTrials.gov Identifier: NCT03460977
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date. Please remember to talk to your healthcare providers first before making decisions about your plan of care.
Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study. To learn more about our trials, call Jennifer at (843) 449-1010 ext. 316 or email us by filling out the form below.
