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.
Eligible Conditions
- Prostate Cancer
- Stage IVB Prostate Cancer
- Castration-Resistant Prostate Cancer
- Stage IV Prostate Cancer
- Stage IVA Prostate Cancer
Treatment Effectiveness
Study Objectives
2 Primary · 11 Secondary · Reporting Duration: From randomization to PSA progression by Prostate Cancer Working Group (PCWG) 3 criteria, assessed up to 2 years
Year 2
Change in levels of serum lactate dehydrogenase (LDH)
Quality of life (QOL)
Year 2
Prostate specific antigen (PSA) progression
Year 2
Symptomatic skeletal event (SSE)
Year 2
Overall survival (OS)
Year 2
ALP progression
Up to 2 years
Alkaline phosphatase (ALP) response
Alkaline phosphatase (ALP) response defined as >= 30% reduction of the blood level, compared to the baseline value
Frequency of mutations in the deoxyribonucleic acid (DNA) repair pathway
Homologous recombination deficiency
Incidence of adverse events
Maximum tolerated dose of olaparib and radium Ra 223 dichloride
Prevalence of germline mutations in homologous recombination genes
Prostate specific antigen (PSA) response
Prostate-Specific Antigen
Radiographic progression free survival (rPFS)
Radiographic progression-free survival (rPFS)
Tumor response
Trial Safety
Trial Design
2 Treatment Groups
Arm II (radium Ra 223 dichloride)
1 of 2
Arm I (radium Ra 223 dichloride, olaparib)
1 of 2
Experimental Treatment
133 Total Participants · 2 Treatment Groups
Primary Treatment: Olaparib · No Placebo Group · Phase 1 & 2
Arm II (radium Ra 223 dichloride)Experimental Group · 3 Interventions: Radium Ra 223 Dichloride, Laboratory Biomarker Analysis, Quality-of-Life Assessment · Intervention Types: Radiation, Other, Other
Arm I (radium Ra 223 dichloride, olaparib)Experimental Group · 4 Interventions: Olaparib, Radium Ra 223 Dichloride, Laboratory Biomarker Analysis, Quality-of-Life Assessment · Intervention Types: Drug, Radiation, Other, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Olaparib
FDA approved
Radium Ra 223 Dichloride
2017
Completed Phase 2
~70
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from randomization to psa progression by prostate cancer working group (pcwg) 3 criteria, assessed up to 2 years
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,076 Previous Clinical Trials
41,139,415 Total Patients Enrolled
537 Trials studying Prostate Cancer
502,396 Patients Enrolled for Prostate Cancer
Rana R McKayPrincipal InvestigatorYale University Cancer Center LAO
1 Previous Clinical Trials
210 Total Patients Enrolled
Eligibility Criteria
Age 18+ · Male Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Participants must have tumor accessible for biopsy and be agreeable to baseline tumor biopsy; a metastatic focus is preferred but if not available and prostate is still intact prostate biopsy can be performed.
Availability of FFPE archival tumor specimens.
Participants must have histologically or cytologically confirmed adenocarcinoma of the prostate.
You have castrate levels of serum testosterone < 50 ng/dL.
You have two or more new lesions on bone scan.
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Conditions
Cancer Related
Treatments