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Androgen Synthesis Inhibitor

olaparib for Prostate Cancer

Phase 3

Waitlist Available

Led By Johann de Bono, M.D., Ph.D.

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up tumor assessments every 8 weeks from randomisation until radiographic progression assessed by bicr (median duration of treatment of 7 and 4 months for olaparib and investigators choice of nha respectively).

Awards & highlights

Study Summary

This trial will compare the effectiveness of olaparib to enzalutamide or abiraterone acetate in treating men with prostate cancer that has spread and is resistant to hormone therapy, who have also previously failed treatment with a new hormonal agent.

Eligible Conditions

Prostate Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ tumor assessments every 8 weeks from randomisation until radiographic progression assessed by bicr (median duration of treatment of 7 and 4 months for olaparib and investigators choice of nha respectively).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~tumor assessments every 8 weeks from randomisation until radiographic progression assessed by bicr (median duration of treatment of 7 and 4 months for olaparib and investigators choice of nha respectively).

This trial's timeline: 3 weeks for screening, Varies for treatment, and tumor assessments every 8 weeks from randomisation until radiographic progression assessed by bicr (median duration of treatment of 7 and 4 months for olaparib and investigators choice of nha respectively). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Radiological Progression Free Survival (rPFS) by Blinded Independent Central Review (BICR) - Cohort A Only

Secondary outcome measures

Confirmed Objective Response Rate (ORR) by Blinded Independent Central Review (BICR) - Cohort A Only

Overall Survival (OS) - Cohort A Only

Radiological Progression Free Survival (rPFS) by Blinded Independent Central Review (BICR) - Cohort A+B

+1 more

Side effects data

From 2023 Phase 3 trial • 387 Patients • NCT02987543

43%

Anaemia

43%

Nausea

30%

Decreased appetite

27%

Fatigue

21%

Diarrhoea

19%

Constipation

19%

Vomiting

14%

Asthenia

14%

Back pain

13%

Oedema peripheral

11%

Cough

10%

Arthralgia

Dyspnoea

Dyspepsia

Weight decreased

Dysgeusia

Thrombocytopenia

Musculoskeletal pain

Dizziness

Urinary tract infection

Headache

Pyrexia

Neutropenia

Musculoskeletal chest pain

Lymphopenia

Insomnia

Stomatitis

Pain in extremity

Pneumonia

Haematuria

Pulmonary embolism

Sepsis

Femur fracture

Hyponatraemia

Muscular weakness

Pneumonia aspiration

Pneumothorax

Cardiopulmonary failure

Urinary retention

Bone pain

Cerebrovascular accident

100%

80%

60%

40%

20%

Study treatment Arm

Cohort A+B Olaparib 300mg bd

Cohort A+B Investigators Choice of NHA

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: OlaparibExperimental Treatment1 Intervention

Olaparib is available as a film-coated tablet containing 150 mg or 100 mg of olaparib. Subjects will be administered study treatment orally at a dose of 300 mg twice daily (bid). The planned dose of 300 mg bid will be made up of two x 150 mg tablets twice daily, with 100 mg tablets used to manage dose reductions

Group II: Enzalutamide OR abiraterone acetateActive Control2 Interventions

Enzalutamide: Enzalutamide is available as capsules or tablets containing 40 mg of enzalutamide. Subjects will be administered study treatment orally at a dose of 160 mg once daily. Abiraterone acetate with prednisone: Abiraterone acetate is available as tablets containing 250 mg or 500 mg of abiraterone acetate. Subjects will be administered study treatment orally at a dose of 1,000 mg once daily in combination with prednisone 5 mg administered twice daily orally. Prednisolone is permitted for use instead of prednisone if necessary.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

olaparib

2009

Completed Phase 3

~690

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Myriad Genetics, Inc.Industry Sponsor

16 Previous Clinical Trials

5,002 Total Patients Enrolled

1 Trials studying Prostate Cancer

595 Patients Enrolled for Prostate Cancer

Foundation Medicine, Inc.UNKNOWN

2 Previous Clinical Trials

833 Total Patients Enrolled

AstraZenecaLead Sponsor

4,257 Previous Clinical Trials

288,593,399 Total Patients Enrolled

60 Trials studying Prostate Cancer

27,522 Patients Enrolled for Prostate Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has olaparib received FDA clearance?

"There is some evidence of olaparib's efficacy and multiple rounds of data supporting safety, so it was given a score of 3."

Answered by AI

Are there unfilled positions in this trial for people who want to participate?

"According to the clinicaltrials.gov website, this study is no longer actively recruiting patients for participation. The trial was initially posted on February 6th, 2017 but was last updated on August 30th, 2022. There are currently 1661 other trials that are still open to enrolling participants."

Answered by AI

What is olaparib's primary indication?

"Olaparib is often used to treat patients with advance directives. It can also help those suffering from malignant neoplasm of ovary, primary peritoneal cancer, and hallucinations caused by somatic conditions."

Answered by AI

How many human subjects are included in this experiment?

"Unfortunately, this particular trial is no longer actively recruiting patients. The study was initially posted on February 6th 2017 and had its last update on August 30th 2022. For individuals who are still looking for other studies, there are 1295 active trials for prostate cancer and 366 for olaparib that need participants."

Answered by AI

What are the precedents for olaparib clinical trials?

"Olaparib was first studied in 2005. There have been 232 completed olaparib clinical trials and there are currently 366 live studies. Many of these active trials are being conducted out of Springfield, Oregon."

Answered by AI

How many different medical facilities are participating in this experiment?

"Right now, 44 different medical sites are looking for patients to enroll in this study. A few examples of these locations include Springfield, Tualatin and Bronx. If you're interested in participating, it would be best to choose a location near you to limit travel time and effort."

Answered by AI

Would this trial benefit from the inclusion of elderly patients?

"This study is taking patients that are over 18 and below 130."

Answered by AI

Could I be a candidate for this clinical research?

"This clinical trial is currently recruiting 387 people who have been diagnosed with prostate cancer. In order to be eligible, participants must be between the ages of 18 and 130 and meet the following criteria: a histologically confirmed diagnosis of prostate cancer, documented evidence of metastatic castration resistant prostate cancer (mCRPC), progression on prior new hormonal agent (e.g. abiraterone acetate and/or enzalutamide) for the treatment of metastatic prostate cancer and/or CRPC, ongoing therapy with LHRH analog or bilateral orchiectomy, radiographic progression at study entry while on androgen deprivation therapy"

Answered by AI

Recent research and studies

New England Journal of MedicineJournal

Olaparib for Metastatic Castration-resistant Prostate Cancer

de Bono, Johann, Joaquin Mateo, Karim Fizazi, Fred Saad, Neal Shore, Shahneen Sandhu, Kim N. Chi, et al.. 2020. “Olaparib for Metastatic Castration-resistant Prostate Cancer”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1911440.

New England Journal of MedicineJournal

Survival with Olaparib in Metastatic Castration-resistant Prostate Cancer

Hussain, Maha, Joaquin Mateo, Karim Fizazi, Fred Saad, Neal Shore, Shahneen Sandhu, Kim N. Chi, et al.. 2020. “Survival with Olaparib in Metastatic Castration-resistant Prostate Cancer”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa2022485.

The Lancet OncologyJournal

Pain and Health-related Quality of Life with Olaparib Versus Physician's Choice of Next-generation Hormonal Drug in Patients with Metastatic Castration-resistant Prostate Cancer with Homologous Recombination Repair Gene Alterations (profound): An Open-label, Randomised, Phase 3 Trial

Thiery-Vuillemin, Antoine, Johann de Bono, Maha Hussain, Guilhem Roubaud, Giuseppe Procopio, Neal Shore, Karim Fizazi, et al.. 2022. “Pain and Health-related Quality of Life with Olaparib Versus Physician's Choice of Next-generation Hormonal Drug in Patients with Metastatic Castration-resistant Prostate Cancer with Homologous Recombination Repair Gene Alterations (profound): An Open-label, Randomised, Phase 3 Trial”. The Lancet Oncology. Elsevier BV. doi:10.1016/s1470-2045(22)00017-1.

Japanese Journal of Clinical OncologyJournal