Study on Two Oral Drugs (Cediranib and Olaparib) vs. One Drug (Olaparib) for Men with Advanced Prostate Cancer

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0

ClinicalTrials ID:NCT02893917

This clinical trial is comparing the effectiveness of two oral drugs, cediranib and olaparib, against just olaparib in treating men with advanced prostate cancer that has spread and is resistant to standard hormone therapy.

Patient Parameters

Program Overview

This study is testing whether a combination of two drugs, cediranib and olaparib, is more effective than olaparib alone in treating men with advanced prostate cancer that has spread and is resistant to hormone therapy. Olaparib works by preventing cancer cells from repairing themselves, while cediranib may stop cancer cells from growing by blocking certain enzymes. The trial aims to see if this combination can better control the cancer.

Description

The main goal of this study is to see if the combination of cediranib and olaparib can help patients live longer without their cancer getting worse, compared to taking olaparib alone. Researchers will also look at how the drugs affect prostate-specific antigen (PSA) levels, tumor size, and overall survival. They will study how well the drugs work in patients with specific DNA repair deficiencies and evaluate the safety of the treatments.

Participants will be randomly assigned to one of two groups. One group will take both cediranib and olaparib, while the other group will take only olaparib. Both groups will take their medications in cycles of 28 days, continuing as long as the treatment is effective and side effects are manageable. After finishing the study treatment, participants will have follow-up visits every six months.

Eligibility Criteria

Inclusion Criteria

  • Men with advanced prostate cancer that has spread and is resistant to hormone therapy.
  • Must have a confirmed diagnosis of prostate adenocarcinoma.
  • Cancer must be documented as spreading through scans.
  • Must have low testosterone levels due to medical or surgical treatment.
  • Must show signs of cancer progression, such as rising PSA levels or new lesions on scans.
  • Must have a tumor that can be safely biopsied.
  • Must agree to provide tumor samples for research.
  • Must have tried at least one previous treatment for advanced prostate cancer.
  • Must have a life expectancy of at least 16 weeks.
  • Must be able to swallow pills and have no digestive issues that affect absorption.
  • Must have controlled blood pressure and thyroid function.
  • Must agree to use effective birth control methods during the study and for three months after.
  • Must be able to understand and sign a consent form.

Exclusion Criteria

  • Recent chemotherapy, hormonal therapy (except certain hormone treatments), or other cancer treatments within the last 21 days.
  • Recent changes in bone-strengthening treatments within 30 days.
  • Untreated or symptomatic brain metastases.
  • Previous treatment with similar drugs to cediranib or olaparib.
  • Allergies to similar drugs.
  • Use of certain medications that interact with the study drugs.
  • Use of herbal products or remedies.
  • Other invasive cancers within the last five years, except for certain skin or bladder cancers.
  • Uncontrolled health conditions, such as heart problems or infections.
  • Recent heart attack or stroke.
  • History of certain heart conditions or surgeries.
  • Recent major surgery or injury.
  • History of bowel obstruction or bleeding.
  • Dependency on IV nutrition.
  • Blood disorders or active infections like HIV or hepatitis.
  • Previous bone marrow transplant.
  • Recent blood transfusions.
  • Involvement in the study's planning or conduct.

Locations

FACILITYZIPCITYSTATE
UC San Diego Moores Cancer Center92093La JollaCalifornia
University of California Davis Comprehensive Cancer Center95817SacramentoCalifornia
UC San Diego Medical Center - Hillcrest92103San DiegoCalifornia
Smilow Cancer Center/Yale-New Haven Hospital06510New HavenConnecticut
Yale University06520New HavenConnecticut
Moffitt Cancer Center33612TampaFlorida
Massachusetts General Hospital Cancer Center02114BostonMassachusetts
Brigham and Women's Hospital02115BostonMassachusetts
Beth Israel Deaconess Medical Center02215BostonMassachusetts
Dana-Farber Cancer Institute02215BostonMassachusetts

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