Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Olaparib Before Surgery in Treating Participants With Localized Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Collaborators:
National Cancer Institute (NCI)
AstraZeneca
Information provided by (Responsible Party):
University of Washington

Study Type Interventional
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
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment (Olaparib, Radical Prostatectomy)
Hide Arm/Group Description

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
Arm/Group Title Treatment (Olaparib, Radical Prostatectomy)
Hide Arm/Group Description

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

Overall Number of Baseline Participants 2
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2 participants
57  (11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
Female
0
   0.0%
Male
2
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
2
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 2 participants
2
 100.0%
1.Primary Outcome
Title Pathologic Complete Response (pCR) Rate
Hide Description Percent of patients who achieve a pCR at the time of prostatectomy, after 12 weeks of neoadjuvant therapy with olaparib. PCR is defined as the absence of morphologically identifiable carcinoma in the prostatectomy specimen. Assessment will be based on the recommendations of the International Society of Urological Pathology (ISUP).
Time Frame At time of prostatectomy (at 12 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Olaparib, Radical Prostatectomy)
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 2
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
2.Primary Outcome
Title Number of Participants With Adverse Events
Hide Description Will be evaluated according to Common Terminology Criteria for Adverse Events (CTCAE).
Time Frame Up to 30 days after the last dose of olaparib
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Olaparib, Radical Prostatectomy)
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 2
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
3.Secondary Outcome
Title Rate of Positive Surgical Margins
Hide Description The rate of detectable tumor in pathology specimens obtained at prostatectomy.
Time Frame At time of prostatectomy (at 12 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Olaparib, Radical Prostatectomy)
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 2
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
4.Secondary Outcome
Title Stage of Disease
Hide Description

Pathology specimens obtained at prostatectomy will be assessed using the tumor, lymph node, and metastasis (TNM) staging system for prostate cancer.

Stage Stage 2 represents patients with disease without evidence of extension outside of the prostate Stage 3 represents patients with disease which has penetrated the capsule of the prostate

Time Frame At time of prostatectomy (at 12 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Olaparib, Radical Prostatectomy)
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 2
Measure Type: Count of Participants
Unit of Measure: Participants
Stage 2
0
   0.0%
Stage 3
2
 100.0%
Time Frame 4 months
Adverse Event Reporting Description Adverse events were collected according to CTCAE version 5
 
Arm/Group Title Treatment (Olaparib, Radical Prostatectomy)
Hide Arm/Group Description

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

All-Cause Mortality
Treatment (Olaparib, Radical Prostatectomy)
Affected / at Risk (%)
Total   0/2 (0.00%) 
Hide Serious Adverse Events
Treatment (Olaparib, Radical Prostatectomy)
Affected / at Risk (%)
Total   0/2 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment (Olaparib, Radical Prostatectomy)
Affected / at Risk (%)
Total   0/2 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Bruce Montgomery, PI
Organization: University of Washington
Phone: 206-598-0860
EMail: rbmontgo@uw.edu
Layout table for additonal information
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