Phase II Study of PARP Inhibitor Olaparib and IV Ascorbate in Castration Resistant Prostate Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05501548|
Recruitment Status : Not yet recruiting
First Posted : August 15, 2022
Last Update Posted : January 20, 2023
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer Castration-resistant Prostate Cancer||Drug: Olaparib Dietary Supplement: Vitamin C||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of PARP Inhibitor Olaparib and IV Ascorbate in Castration Resistant Prostate Cancer|
|Estimated Study Start Date :||March 2023|
|Estimated Primary Completion Date :||March 2028|
|Estimated Study Completion Date :||March 2028|
Experimental: Olaparib and Vitamin C
Olaparib will be administered at 300 mg by mouth, twice daily; ascorbate will be administered at 1 g/kg IV twice weekly at least 24 hours apart, until objective disease progression or unacceptable toxicities or patient withdrawal for other reasons.
Olaparib 300mg by mouth twice daily
Dietary Supplement: Vitamin C
Ascorbic acid 1g/kg administered intravenously twice weekly
- PSA50 response [ Time Frame: up to 5 years ]Number of participants with metastatic castration resistance prostate cancer (mCRPC) who experience a 50% reduction in prostate specific antigen (PSA50) from baseline. PSA50 response will be defined as a decrease in the PSA to 50% less than the baseline PSA upon enrollment in the trial. The decrease must be confirmed by a second measurement at least 4 weeks apart. PSA values will be measured monthly during the trial.
- Safety and tolerability of olaparib in combination with IV ascorbic acid in patients with mCRPC [ Time Frame: up to 5 years ]Number of participants experiencing treatment-related adverse events as defined by NCI CTCAE v5.0.
- PSA doubling time in patients with mCRPC receiving olaparib in combination with IV ascorbic acid [ Time Frame: up to 5 years ]Median number of months to PSA doubling from the initiation of therapy until the PSA has increased to 200% of baseline value, and confirmed with another measurement at least 4 weeks later, or death. The date of PSA doubling will be the first value recorded (not the confirmatory value).
- Radiographic progression free survival (rPFS) of patients with mCRPC receiving olaparib in combination with IV ascorbic acid [ Time Frame: up to 5 years ]Number of months from initiation of therapy to date of first radiographic progression, death from any cause, or last patient evaluation. Radiographic progression will be defined as soft tissue disease progression by modified RECIST criteria 1.1 (baseline LN size must be >1.0 cm to be considered target or evaluable lesion) or by development of two or more new bone lesions not consistent with tumor flair for prostate cancer working group 3.
- PSA progression free survival (PSA PFS) of patients with mCRPC receiving olaparib in combination with IV ascorbic acid [ Time Frame: up to 5 years ]Number of months to first PSA failure (two consecutive increases in PSA of 50% and >=5ng/mL above nadir) or death
- Overall survival of patients with mCRPC receiving olaparib in combination with IV ascorbic acid [ Time Frame: up to 5 years ]Number of months from initiation of therapy to death due to any cause
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05501548
|Contact: Kathy Schultz, RNfirstname.lastname@example.org|
|United States, District of Columbia|
|Sibley Memorial Hospital|
|Washington, District of Columbia, United States, 20016|
|Contact: Jan Powers, MSN 202-660-6324 email@example.com|
|Principal Investigator: Channing Paller, MD|
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Baltimore, Maryland, United States, 21287|
|Contact: Kathy Schultz, RN 410-614-9482 firstname.lastname@example.org|
|Principal Investigator: Channing Paller, MD|
|Principal Investigator:||Channing Paller, MD||Johns Hopkins University|