A Study of Olaparib and Durvalumab in Prostate Cancer (NCT03810105) | Clinical Trial Compass
TerminatedPhase 2
A Study of Olaparib and Durvalumab in Prostate Cancer
Stopped: Due to low accrual
United States5 participantsStarted 2019-03-07
Plain-language summary
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.
Who can participate
Age range18 Years
SexMALE
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Inclusion Criteria:
* Willing and able to provide written informed consent and HIPAA authorization for the release of personal health information. A signed informed consent must be obtained before screening procedures are performed.
NOTE: HIPAA authorization may be either included in the informed consent or obtained separately.
* Males 18 years of age and above
* Body weight \> 30kg
* History of radical prostatectomy
* Histologically confirmed prostate cancer with progressive disease defined as:
* Rising PSA (50% or more increase to a level of 0.50 ng/mL or more, based on at least 3 PSA determinations obtained at least 1 week apart). The 50% rise in PSA is across the 3 determinations, and these determinations do not need to be sequential.
* PSA doubling time of \</= 9 months as calculated according to the Memorial Sloan Kettering Cancer Center nomogram
* No evidence of metastatic disease on conventional imaging (CT/MRI and bone scan). However, subjects with pelvic and/or retroperitoneal nodes \< 2cm in the short axis will be permitted on study, as they are considered not to have definitive metastases. (Note: Metastatic disease on investigational imaging, Prostate Specific Membrane Antigen-targeted (PSMA) PET, PET-choline, or other novel PET tracers who do not have evidence of metastatic disease using conventional imaging (CT/MRI, bone scan) are allowed.)
* Molecular evidence of DDR deleterious mutations (somatic or germline), including BRCA1, BRCA2, ATM, CHEK2, FANCA, RAD5…
What they're measuring
1
Therapeutic Efficacy as Defined by Number of Participants With an Undetectable PSA