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PARP Inhibitor

Olaparib + Radium-223 for Prostate Cancer

Phase 1 & 2
Waitlist Available
Led By Rana R McKay
Research Sponsored by National Cancer Institute (NCI)
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 from randomization to psa progression by prostate cancer working group (pcwg) 3 criteria, assessed up to 2 years
Awards & highlights

Study Summary

This trial is testing olaparib, a PARP inhibitor, as a possible treatment for metastatic castration-resistant prostate cancer. The trial will also study the best dose of olaparib and the side effects of the combination treatment.

Who is the study for?
Men with advanced prostate cancer that has spread to the bones and is resistant to castration can join this trial. They must have low testosterone levels, progressive disease, at least two bone metastases not previously treated with radiation, and be able to take oral medications. Men must agree to use contraception and avoid sperm donation during the study. Those with HIV are eligible if well-controlled.Check my eligibility
What is being tested?
The trial is testing different doses of Olaparib combined with Radium-223 in men whose prostate cancer has spread to their bones. Olaparib blocks proteins that repair tumor DNA, potentially stopping cancer growth; Radium-223 delivers radiation directly to tumor cells.See study design
What are the potential side effects?
Olaparib may cause nausea, vomiting, fatigue, anemia (low red blood cell counts), or more serious side effects like lung inflammation or blood clots. Radium-223 can lead to similar issues plus bone marrow suppression which affects blood cell production.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization to psa progression by prostate cancer working group (pcwg) 3 criteria, assessed up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization to psa progression by prostate cancer working group (pcwg) 3 criteria, assessed up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum tolerated dose of olaparib and radium Ra 223 dichloride
Radiographic progression-free survival (rPFS)
Secondary outcome measures
ALP progression
Alkaline phosphatase (ALP) response
Incidence of adverse events
+6 more
Other outcome measures
Change in levels of serum lactate dehydrogenase (LDH)
Frequency of mutations in the deoxyribonucleic acid (DNA) repair pathway
Homologous recombination deficiency
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm II (radium Ra 223 dichloride)Experimental Treatment7 Interventions
Patients receive radium Ra 223 dichloride as in Arm I. Patients with radiographic progression may crossover to Arm I. If patients have already completed all 6 infusions of radium, they will receive monotherapy with olaparib. If they have not yet completed all 6 radium-223 infusion, they will continue radium-223 infusion until completion and receive concurrent treatment with olaparib. Patients also undergo CT or MRI as well as blood sample collection and a tissue biopsy during screening and on study.
Group II: Arm I (radium Ra 223 dichloride, olaparib)Experimental Treatment8 Interventions
Patients receive radium Ra 223 dichloride IV over 1 minute on day 1. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive olaparib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI as well as blood sample collection and a tissue biopsy during screening and on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biopsy
2014
Completed Phase 4
~850
Biospecimen Collection
2004
Completed Phase 2
~1730
Computed Tomography
2017
Completed Phase 2
~2720
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Olaparib
2007
Completed Phase 4
~2140
Radium Ra 223 Dichloride
2017
Completed Phase 2
~90

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,932,190 Total Patients Enrolled
561 Trials studying Prostate Cancer
507,173 Patients Enrolled for Prostate Cancer
Rana R McKayPrincipal InvestigatorYale University Cancer Center LAO
1 Previous Clinical Trials
210 Total Patients Enrolled

Media Library

Olaparib (PARP Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03317392 — Phase 1 & 2
Prostate Cancer Research Study Groups: Arm I (radium Ra 223 dichloride, olaparib), Arm II (radium Ra 223 dichloride)
Prostate Cancer Clinical Trial 2023: Olaparib Highlights & Side Effects. Trial Name: NCT03317392 — Phase 1 & 2
Olaparib (PARP Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03317392 — Phase 1 & 2

Frequently Asked Questions

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

What is the current enrollment size for this investigation?

"Affirmative. Clinicaltrials.gov indicates that this research endeavour, which was first made public on October 12th 2018, is actively seeking qualified candidates. The trial requires 133 participants to be sourced from 19 distinct sites."

Answered by AI

What primary objectives is the research endeavor striving to accomplish?

"This planned two-year trial seeks to establish the maximum tolerable dose of olaparib and radium Ra 223 dichloride. The primary endpoints are tumour response, which is evaluated under RECIST 1.1 criteria; prostate specific antigen (PSA) progression; and symptomatic skeletal event (SSE). These outcomes will be compared between treatment arms via Fisher's exact tests, Kaplan-Meier estimations, and stratified log-rank tests respectively."

Answered by AI

How many facilities are offering access to this clinical research?

"The investigation is presently being conducted across 19 distinct sites, including Westwood, Kansas City and Creve Coeur. To minimize the need for travel, it would be wise to choose a clinic located nearby."

Answered by AI

Is there any additional research related to Olaparib?

"In 2005, Research Site began exploring the medical applications of olaparib. Since then, 760 clinical trials have concluded and there are currently 197 open studies primarily located in Westwood, Kansas."

Answered by AI

What maladies is Olaparib commonly prescribed to alleviate?

"Olaparib is typically used to treat advance directives, yet it may also prove efficacious against malignant neoplasms of the ovary, primary peritoneal cancer, and somatic hallucinations."

Answered by AI

Is this experiment still taking in participants?

"According to clinicaltrials.gov, this research is still enrolling participants. Initially posted on October 12th 2018, the trial was last modified on December 2nd 2022."

Answered by AI

Has this type of study been conducted before?

"Olaparib has been subject to research since 2005, when AstraZeneca first sponsored a study of 98 participants. Since then the drug has achieved Phase 1 approval and is currently being trialled in 1519 cities across 60 different nations with 197 live trials occurring presently."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Testing the Safety of Different Doses of Olaparib Given Radium-223 for Men With Advanced Prostate Cancer With Bone Metastasis
2019. "Testing the Safety of Different Doses of Olaparib Given Radium-223 for Men With Advanced Prostate Cancer With Bone Metastasis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03317392.
~13 spots leftby Nov 2024
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