Olaparib for Prostate Cancer

Recruiting at 2 trial locations

Overseen By Catherine H Marshall, MD

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Must not be taking: Anti-androgens, Chemotherapy, PARP inhibitors, others

Disqualifiers: HIV, Hepatitis B/C, MDS/AML, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Minimum 12 weeks

51 Participants Needed

Trial Summary

What is the purpose of this trial?

Olaparib has demonstrated preliminary efficacy in metastatic castration-resistant prostate cancer. In a trial of 49 evaluable patients treated with olaparib, 11 / 49 experienced a PSA response, and every patient with a radiographic response also had a PSA5 response. Ten of 11 responders had mutations in DNA repair genes. While PARP inhibition is showing promise in these initial studies, reserving its use for end-stage patients may not be the optimal timing for olaparib therapy in some patients. In addition, PARP enzymes function in roles beyond DNA repair, and specifically for prostate cancer are involved transcriptional regulation of the androgen receptor. PARP inhibition has not been tested in earlier disease states for prostate cancer.

Research Team

Catherine H Marshall, MD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

Men with high-risk, non-metastatic prostate cancer post-prostatectomy can join this trial. They should have a rapidly rising PSA level, good physical condition (ECOG 0-1), and no prior ADT or strong CYP3A inhibitors in the last 6 months. Participants need normal organ/bone marrow function and agree to use effective contraception.

Inclusion Criteria

My recent scans show no signs of cancer spread.

PSADT ≤6 months, based upon ≥3 consecutive measurements collected in the past 12 months, at least 4 weeks apart

My organ and bone marrow functions are normal as tested within the last 28 days.

Exclusion Criteria

I have been diagnosed with myelodysplastic syndrome or acute myeloid leukemia.

I had major surgery more than 2 weeks ago and have recovered from it.

I cannot swallow pills or have a stomach condition that affects medication absorption.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive olaparib at 300mg twice daily until PSA doubling, development of metastatic disease, or unacceptable toxicity

Minimum 12 weeks

Monthly clinic visits for safety labs, PSA, and toxicity assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Long-term follow-up

Participants are monitored for PSA progression-free survival and treatment-related adverse events

Up to 7 years

Treatment Details

Interventions

• Olaparib

Trial Overview The trial is testing Olaparib's effectiveness for prostate cancer at an earlier stage than previously studied. It involves men whose cancer has returned biochemically after surgery but hasn't spread elsewhere, focusing on those with specific genetic mutations linked to DNA repair.

Participant Groups

Group I: Olaparib 300 mg BID Experimental Treatment 1 Intervention

Patients will be administered olaparib orally twice daily at 300mg bid continually. Two 150mg of olaparib tablets should be taken twice daily, approximately 12 hours apart with one glass of water.

Olaparib is already approved in European Union, United States for the following indications:

Approved in European Union as Lynparza for:

• Breast cancer
• Ovarian cancer
• Fallopian tube cancer
• Peritoneal cancer
• Pancreatic cancer
• Prostate cancer
• Endometrial cancer

Approved in United States as Lynparza for:

• Ovarian, fallopian tube, and primary peritoneal cancer
• Breast cancer
• Prostate cancer
• Pancreatic cancer

Who Is Running the Clinical Trial?

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Lead Sponsor

Trials

578

Recruited

33,600+

AstraZeneca

Industry Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology