Newly Diagnosed Prostate Cancer

Radical Prostatectomy

PROTEUS: 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: Apalutamide with ADT vs. ADT with placebo
Estimated Study Completion Date: April 22, 2024
ClinicalTrials.gov Identifier: NCT03767244

APA-RAP PCR2041: A Multi-center, Open-label, Single-arm Phase 2 Study of the Adjuvant Treatment of Apalutamide and Androgen Deprivation Therapy (ADT) in Treatment-naïve Participants Who Have Undergone Radical Prostatectomy (RP) for Non-metastatic Prostate Cancer and Who Are at High Risk for Metastases 

Phase: 2
Study Product: Apalutamide with ADT post radical prostatectomy (RP)
Estimated Study Completion Date: December 11, 2023
ClinicalTrials.gov Identifier: NCT04523207

Radiation Therapy

PrTK03: A Randomized Controlled Trial of Prostatak® As Adjuvant To Upfront Radiation Therapy for Localized Prostate Cancer

Phase: 3
Study Product: ProstAtak + valacyclovir adjuvant to up-front radiation therapy vs. placebo + valacyclovir adjuvant to up-front radiation therapy
Estimated Study Completion Date: December 2022
ClinicalTrials.gov Identifier: NCT01436968

PSA Relapse

MAP: Muscadine Plus (MPX) In Men With Prostate Cancer

Phase: 3
Study Product: Muscadine Plus
Estimated Study Completion Date: December 2021
ClinicalTrials.gov Identifier: NCT03535675

RhoVac-002: A Phase 2, Double-Blind, Placebo Controlled Study of RV001V in Men with Biochemical Failure following Curatively Intended Therapy For Localized Prostate Cancer

Phase: 2
Study Product: RV001V
Estimated Study Completion Date: September 2022
ClinicalTrials.gov Identifier: NCT04114825

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

C3441052: Talapro-3: A Phase 3, Randomized, Double-Blind, Study of Talazoparib with Enzalutamide vs. placebo with Enzalutamide in men with DDR Gene Mutated Metastatic Castration Sensitive Prostate Cancer

Phase: 3
Study Product: talazoparib + enzalutamide vs. placebo + enzalutamide
Estimated Study Completion Date: April 10, 2027
ClinicalTrials.gov Identifier: NCT04821622

CSPC or CRPC

Prior to Abiraterone

Propella: Open-Label, Multicenter Study of Intramuscular PRL-02 Depot in Patients with Advanced Prostate Cancer

Phase: 1
Study Product: Abiraterone decanoate
Estimated Study Completion Date: December 31, 2023
ClinicalTrials.gov Identifier: NCT04729114

Responding to Abiraterone

MVY-601-049: A Phase 1, Open-Label, Single-Cohort Safety and Tolerability Study of Relugolix in Combination with Abiraterone plus Prednisone in Men with High-Risk Metastatic Castration-Sensitive Prostate Cancer or Metastatic Castration-Resistant Prostate Cancer Being Treated with Standard-of-Care Leuprolide and Abiraterone plus Prednisone

Phase: 1
Study Product: Relugolix + Abiraterone
Estimated Study Completion Date: December 2021
ClinicalTrials.gov Identifier: NCT04666129

Progressing on Abiraterone Acetate

DisperSol: A PK and Dose Escalation and Expansion Study of DST-2970 in Patients With Prostate Cancer With Rising PSA on Treatment With Abiraterone Acetate

Phase: 1
Study Product: Abiraterone Acetate plus Prednisone 5Mg Tab plus DST-2970 (Abiraterone)
Estimated Study Completion Date: July 31, 2022
ClinicalTrials.gov Identifier: NCT04291664

nmCRPC or MCRPC

DaroAct 20609: Study to Compare the Effects of Drug Darolutamide and Drug Enzalutamide on Physical Function, Including Balance and Daily Activity, in Patients With Castration-resistant Prostate Cancer (CRPC)

Phase: 2b
Study Product: Darolutamide vs. Enzalutamide
Estimated Study Completion Date: December 31, 2022
ClinicalTrials.gov Identifier: NCT04157088

mCRPC

Treatment naïve

TALAPRO-2: Talazoparib + Enzalutamide vs. Enzalutamide Monotherapy in mCRPC

Phase: 3
Study Product: Talazoparib with Enzalutamide vs. Placebo with Enzalutamide
Estimated Study Completion Date: November 25, 2024
ClinicalTrials.gov Identifier: NCT03395197

ESCALATE: Enzalutamide or Darolutamide (1:1) 12 week run-in then add Radium-223

Phase: 3
Study Product: Enzalutamide vs. Darolutamide with Radium-223
Estimated Study Completion Date: September 2024
ClinicalTrials.gov Identifier: NCT04237584

Post Abi or Enza 

KEYNOTE-641: Study of Pembrolizumab (MK-3475) Plus Enzalutamide Versus Placebo Plus Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer

Phase: 3
Study Product: Pembrolizumab with Enzalutamide vs. Placebo with Enzalutamide
Estimated Study Completion Date: November 12, 2023
ClinicalTrials.gov Identifier: NCT03834493

Docetaxel Candidate

BMS CA209-7DX: Study of Nivolumab or Placebo in Combination With Docetaxel in Men With Advanced Castration-resistant Prostate Cancer 

Phase: 3
Study Product: Nivolumab + Docetaxel Vs. Placebo + Docetaxel
Estimated Study Completion Date: July 6, 2024
ClinicalTrials.gov Identifier: NCT0410001

Progressing on NHA (Abi or Enza)

ORIC-101-02: An Open-Label Phase 1b Study of ORIC-101 in Combination With Enzalutamide in Patients With Metastatic Prostate Cancer Progressing on Enzalutamide

Phase: 1b
Study Product: ORIC-101 vs. Enzalutamide
Estimated Study Completion Date: December 2022
ClinicalTrials.gov Identifier: NCT04033328

PLX124-04: A Multicenter, Open-Label, Parallel, Phase 1b/2a Study of PLX2853 in Combination with Abiraterone Acetate and Prednisone and Phase 1b/2a Study of PLX2853 in Combination with Olaparib in Subjects with Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Phase: 1b/2a
Study Product: PLX2853 + Abiraterone Acetate & Prednisone versus PLX2853 + Olaparib
Estimated Study Completion Date: March 30, 2023
ClinicalTrials.gov Identifier: NCT04556617

Post Abi and/or Enza

Pfizer c2321001: PF-06821497 Treatment Of Relapsed/Refractory SCLC, Castration Resistant Prostate Cancer, and Follicular Lymphoma

Phase: 1
Study Product: PF-06821497
Estimated Study Completion Date: October 13, 2021
ClinicalTrials.gov Identifier: NCT03460977

AZ D5339C00001: A Modular Phase 2a Multicentre Open-Label Study to Investigate DNA-damage Response Agents (or Combinations) in Patients With Advanced Cancer Whose Tumours Contain Molecular Alterations (PLANETTE)

Phase: 2a
Study Product: Ceralasertib
Estimated Study Completion Date: June 8, 2023
ClinicalTrials.gov Identifier: NCT04564027

Olaparib PLX124-04: A Multicenter, Open-Label, Parallel, Phase 1b/2a Study of PLX2853 in Combination with Abiraterone Acetate and Prednisone and Phase 1b/2a Study of PLX2853 in Combination with Olaparib in Subjects with Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Phase: 1b/2a
Study Product: PLX2853 + Abiraterone Acetate & Prednisone versus PLX2853 + Olaparib
Estimated Study Completion Date: March 30, 2023
ClinicalTrials.gov Identifier: NCT04556617

Post Abi, Enza, Apa, and/or Daro

FORMA 7051-ONC-101: A Phase 1 Study of FT-7051 in Men with Metastatic Castration-Resistant Prostate Cancer 

Phase: 1
Study Product: FT-7051
Estimated Study Completion Date: July 2023
ClinicalTrials.gov Identifier: NCT04575766

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.