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TERMINATEDPHASE2

Phase II Study of PARP Inhibitor Olaparib and IV Ascorbate in Castration Resistant Prostate Cancer

NCT05501548•Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Summary

This is a study to evaluate the safety and clinical activity of the combination of olaparib and high-dose IV ascorbate, as second or later line of therapy, in castration resistant prostate cancer patients with no known DNA repair gene mutations (DDRm). In brief, the primary endpoint is PSA50 response , defined by a 50% reduction in PSA from baseline . The secondary endpoints are assessing the PSA doubling time, radiographic and PSA PFS, safety and tolerability as defined by the incidence of grade 3 to 5 toxicities, and measuring overall survival.

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•Have metastatic castration-resistant prostate cancer (prostate cancer progressing by PSA (rise by 25% on prior therapy) or imaging despite castrate levels of testosterone \[\<50 ng/dL\] using standard measures of progression defined by Prostate Cancer Working Group3)
•Have a minimum PSA of 1 ng/mL
•Have a pathological diagnosis of prostate carcinoma
•Patients should continue receiving continuous hormonal ablation with surgical or medical castration with baseline testosterone \<50ng/dL
•Patients may be receiving bone-targeted agents
•May have received multiple lines of therapy including radium 223, sipuleucel T, and up to 2 lines of chemotherapy (One of 2 lines may be for hormone sensitive metastatic prostate cancer or both can be for castration resistant).
•Age \>= 18
•Have ECOG performance status 0-1 (Appendix A)
•Be able to take oral medication and willing to consider a port for ease of administration of ascorbate
•Must have progressed on one systemic line of treatment (can include LHRH agonist/antagonist or orchiectomy and one additional line of therapy (abiraterone, enzalutamide, apalutamide, darolutamide, docetaxel, etc))
+10 more criteria

Exclusion Criteria

•Have a known DNA repair mutation (minimum list of genes that must be mutation negative for inclusion: ATM, BARD1, BRCA1, BRCA2, BRIP1, CDK12, CHEK1, CHEK2, FANCL, PALB2, RAD51B, RAD51C, RAD51D, RAD45L). In addition, patients who have not completed germline and somatic testing to rule out such a mutation are ineligible until they have completed testing. If tissue or liquid ctDNA sequencing was not previously done, testing using the Foundation One liquid biopsy test or an equivalent FDA-approved test is acceptable as standard of care.
•* DNA repair mutation variant of unknown significance (VUS) allowed
•Have had known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
•Patients with symptomatic uncontrolled brain metastases. A scan to confirm the absence of brain metastases is not required. The patient can receive a stable dose of corticosteroids before and during the study as long as these were started at least 4 weeks prior to treatment. Patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days.
•No prior olaparib, rucaparib, or other PARP inhibitor
•Have had major surgery within 2 weeks of dosing of investigational agent
•Have had palliative radiation or another biological cancer therapy within 2 weeks prior to the first dose of study drug (2 week wash out required)
•Patients receiving any systemic chemotherapy or radiotherapy within 3 weeks prior to study treatment
•Have received other investigational drugs within 14 days prior to enrollment.
•Is expected to require chemotherapy or radiation for pain palliation in the next 12 weeks.
+15 more criteria

Locations (2)

Sibley Memorial Hospital

Washington D.C., District of Columbia, United States

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

Key Dates

Start Date

June 30, 2023

Primary Completion Date

October 14, 2024

Completion Date

October 14, 2024

Last Updated

January 29, 2025

Enrollment

ACTUAL participants

Conditions

Prostate CancerCastration-resistant Prostate Cancer

Interventions

Olaparib

DRUG

Vitamin C

DIETARY_SUPPLEMENT

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 29, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Phase II Study of PARP Inhibitor Olaparib and IV Ascorbate in Castration Resistant Prostate Cancer

Inclusion Criteria

Exclusion Criteria

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

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PSMA-PET: Deep Radiomic Biomarkers of Progression and Response Prediction in Prostate Cancer

Phase 2a Study of High-Dose Testosterone Followed by Radioligand Therapy in mCRPC