Phase II Study of Olaparib and IV Vitamin C in Advanced Prostate Cancer

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05501548

This clinical trial is testing a combination of the drug olaparib and high-dose intravenous vitamin C to see if it is safe and effective for men with advanced prostate cancer that has not responded to other treatments. The study focuses on patients without specific DNA repair gene mutations.

Patient Parameters

Program Overview

The study aims to evaluate the safety and effectiveness of combining olaparib, a PARP inhibitor, with high-dose intravenous vitamin C in men with advanced prostate cancer that continues to grow despite low testosterone levels. The main goal is to see if this treatment can reduce PSA levels by 50%. Other goals include assessing how long it takes for PSA levels to double, the time until the cancer progresses, and overall survival. The study will also monitor any side effects experienced by participants.

Eligibility Criteria

Inclusion Criteria

  • Have advanced prostate cancer that continues to grow despite low testosterone levels.
  • Have a PSA level of at least 1 ng/mL.
  • Have a confirmed diagnosis of prostate cancer.
  • Continue receiving hormone therapy to keep testosterone levels low.
  • May be taking medications to protect bones.
  • May have had multiple previous treatments, including certain chemotherapies.
  • Be 18 years or older.
  • Be in good overall health, able to perform daily activities with minimal restrictions.
  • Be able to take oral medication and consider using a port for vitamin C administration.
  • Have tried at least one other systemic treatment for prostate cancer.
  • Have normal organ and bone marrow function based on recent blood tests.
  • Men must agree to use effective birth control during and for six months after treatment.
  • Understand and agree to participate in the study by signing a consent form.

Exclusion Criteria

  • Have known mutations in specific DNA repair genes.
  • Have active cancer spread to the brain or spinal cord.
  • Have previously used olaparib or similar drugs.
  • Have had major surgery or certain cancer treatments recently.
  • Need chemotherapy or radiation for pain relief soon.
  • Use certain medications that interact with the study drugs.
  • Have significant heart disease or uncontrolled medical conditions.
  • Have other active cancers unless treated and disease-free for over five years.
  • Have persistent side effects from previous cancer treatments.
  • Have blood disorders like myelodysplastic syndrome or leukemia.
  • Have difficulty swallowing pills or absorbing oral medications.
  • Have active hepatitis or have had certain types of transplants.
  • Have allergies to olaparib or its ingredients.

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