Olaparib Before Surgery in Treating Participants With Localized Prostate Cancer
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ClinicalTrials.gov Identifier: NCT03570476 |
Recruitment Status :
Terminated
(Terminated due to slow accrual)
First Posted : June 27, 2018
Results First Posted : September 21, 2020
Last Update Posted : September 21, 2020
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Sponsor:
University of Washington
Collaborators:
National Cancer Institute (NCI)
AstraZeneca
Information provided by (Responsible Party):
University of Washington
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Study Type | Interventional |
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Study Design | Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Conditions |
Prostate Adenocarcinoma Without Neuroendocrine Differentiation Stage I Prostate Cancer AJCC v8 Stage II Prostate Cancer AJCC v8 Stage IIA Prostate Cancer AJCC v8 Stage IIB Prostate Cancer AJCC v8 Stage IIC Prostate Cancer AJCC v8 |
Interventions |
Drug: Olaparib Procedure: Radical Prostatectomy |
Enrollment | 2 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Treatment (Olaparib, Radical Prostatectomy) |
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Participants receive olaparib orally twice daily for 90 days in the absence of unacceptable toxicity. Beginning 1 day after last olaparib dose, participants undergo radical prostatectomy. Olaparib: Given PO Radical Prostatectomy: Undergo surgery |
Period Title: Overall Study | |
Started | 2 |
Completed | 2 |
Not Completed | 0 |
Baseline Characteristics
Arm/Group Title | Treatment (Olaparib, Radical Prostatectomy) | |
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Participants receive olaparib PO BID for 90 days in the absence of unacceptable toxicity. Beginning 1 day after last olaparib dose, participants undergo radical prostatectomy. Olaparib: Given PO Radical Prostatectomy: Undergo surgery |
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Overall Number of Baseline Participants | 2 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 2 participants | |
57 (11) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 2 participants | |
Female |
0 0.0%
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Male |
2 100.0%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 2 participants | |
American Indian or Alaska Native |
0 0.0%
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Asian |
0 0.0%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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Black or African American |
0 0.0%
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White |
2 100.0%
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More than one race |
0 0.0%
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Unknown or Not Reported |
0 0.0%
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Region of Enrollment
Measure Type: Count of Participants Unit of measure: Participants |
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United States | Number Analyzed | 2 participants |
2 100.0%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Dr. Bruce Montgomery, PI |
Organization: | University of Washington |
Phone: | 206-598-0860 |
EMail: | rbmontgo@uw.edu |
Responsible Party: | University of Washington |
ClinicalTrials.gov Identifier: | NCT03570476 |
Other Study ID Numbers: |
9985 NCI-2018-00977 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) 9985 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium ) P30CA015704 ( U.S. NIH Grant/Contract ) RG1718008 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium ) |
First Submitted: | June 5, 2018 |
First Posted: | June 27, 2018 |
Results First Submitted: | August 7, 2020 |
Results First Posted: | September 21, 2020 |
Last Update Posted: | September 21, 2020 |