Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Immune System Diseases

Recurrence

Prostatic Neoplasms

Hypersensitivity

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Antineoplastic Agents

All Drugs and Chemicals

Durvalumab

Olaparib

Antineoplastic Agents, Immunological

Poly(ADP-ribose) Polymerase Inhibitors

Enzyme Inhibitors

Castration Sensitive Biochemically Recurrent Non-Metastatic Prostate Cancer

Olaparib 300mg twice daily (600mg total daily dose)

Karen Autio, MD, MsC

The purpose of this study is to determine if the combination of olaparib and durvalumab are better than the standard of care for treating prostate cancer.

A Study of Olaparib and Durvalumab in Prostate Cancer

A Phase II Study of Olaparib and Durvalumab in Men With Castration Sensitive Biochemically Recurrent Non-Metastatic Prostate Cancer Harboring Mutations in DNA Damage Repair

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

To assess the therapeutic efficacy as defined by an undetectable PSA (\<0.05 or PSA \<0.10 for institutions where this is the lower limit of detection) with non-castrate levels of testosterone using the combination olaparib (PARP inhibition) with durvalumab (PDL1 inhibition) at 24 months (cycle 24) in biochemically recurrent prostate cancer

Memorial Sloan Kettering Cancer Center

Castration Sensitive Biochemically Recurrent Non-Metastatic Prostate Cancer

Olaparib: Olaparib 300mg twice daily (600mg total daily dose)

Durvalumab: Durvalumab 1500mg IV monthly

Castration Sensitive Biochemically Recurrent Prostate Cancer

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Karen Autio, MD

Therapeutic Efficacy as Defined by Number of Participants With an Undetectable PSA

Overall Study

Spots Global Cancer Trial Database for A Study of Olaparib and Durvalumab in Prostate Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial