NCT05501548

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer
• Castration-resistant Prostate Cancer

Interventions

Type	Name	Description
DRUG	Olaparib	Olaparib 300mg by mouth twice daily
DIETARY_SUPPLEMENT	Vitamin C	Ascorbic acid 1g/kg administered intravenously twice weekly

Timeline

• Start date: 2023-06-30
• Primary completion: 2024-10-14
• Completion: 2024-10-14
• First posted: 2022-08-15
• Last updated: 2025-01-29
• Results posted: 2025-01-29

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study