Back to resultsImpact of Hormonal Therapy on Prostate Cancer Recurrence After Radical Prostatectomy
Primary Purpose
Prostate Cancer
Status
Recruiting
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Lupron Depot
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer
Eligibility Criteria
Inclusion Criteria:
- undetectable PSA (<0.02 ng/ml) within 8 weeks post-operative;
- ≥25% predicted risk of PSA recurrence within 5 years of surgery (based on the Kattan nomogram)
Exclusion Criteria:
- Unwilling to receive ADT;
- previously received ADT;
- lymph node metastases
- allergy to any form of ADT
Sites / Locations
- The Ottawa HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Standard of Care
Standard of Care plus Androgen Deprivation Therapy (Lupron Depot)
Arm Description
Standard of Care
22.5 mg intra-muscular injection of Lupron Depot every 3 months for 12 months (4 injections total)
Outcomes
Primary Outcome Measures
Rate of enrolment
Rate (patients/month) of enrolment
Secondary Outcome Measures
Rate of enrolment per site
Rate (patients/month) of enrolment per site
Proportion of patients completing study intervention per-protocol
Proportion of patients completing study intervention per-protocol
Time to study start-up
Time to study start-up at each site
Completeness of study assessments
Proportion of study assessments completed per-protocol
Full Information
NCT ID
NCT05169112
First Posted
March 1, 2021
Last Updated
March 21, 2023
Sponsor
Ottawa Hospital Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT05169112
Brief Title
Impact of Hormonal Therapy on Prostate Cancer Recurrence After Radical Prostatectomy
Official Title
The Impact of Adjuvant Androgen Deprivation Following Radical Prostatectomy on Prostate Cancer Recurrence
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 6, 2023 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ottawa Hospital Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Prostate cancer is the most common cancer in men and radical prostatectomy is the most frequent treatment for this disease. Unfortunately, approximately 40% of patients will develop recurrence after surgery, requiring additional salvage radiation. Salvage radiation after recurrence is successful in less than half of these men and most of those die from their disease. Measures to prevent recurrence are an important research priority for prostate cancer patients and their families. Hormonal therapy (androgen deprivation therapy; ADT) is routinely used to treat patients with metastases, but few clinical trials have examined if adjuvant ADT after surgery will prevent cancer recurrence. We aim to address this research oversight and test the hypothesis that for men at high risk of cancer recurrence, 1 year of ADT immediately after surgery will be safe and will significantly improve cancer outcomes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Standard of Care
Arm Title
Standard of Care plus Androgen Deprivation Therapy (Lupron Depot)
Arm Type
Experimental
Arm Description
22.5 mg intra-muscular injection of Lupron Depot every 3 months for 12 months (4 injections total)
Intervention Type
Drug
Intervention Name(s)
Lupron Depot
Intervention Description
Patients randomized to receive androgen deprivation therapy (ADT) will receive 12 months of Lupron Depot (22.5 mg) administered every 3 months
Primary Outcome Measure Information:
Title
Rate of enrolment
Description
Rate (patients/month) of enrolment
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Rate of enrolment per site
Description
Rate (patients/month) of enrolment per site
Time Frame
1 year
Title
Proportion of patients completing study intervention per-protocol
Description
Proportion of patients completing study intervention per-protocol
Time Frame
1 year
Title
Time to study start-up
Description
Time to study start-up at each site
Time Frame
1 year
Title
Completeness of study assessments
Description
Proportion of study assessments completed per-protocol
Time Frame
1 year
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
undetectable PSA (<0.02 ng/ml) within 8 weeks post-operative;
≥25% predicted risk of PSA recurrence within 5 years of surgery (based on the Kattan nomogram)
Exclusion Criteria:
Unwilling to receive ADT;
previously received ADT;
lymph node metastases
allergy to any form of ADT
Facility Information:
Facility Name
The Ottawa Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rodney H Breau, MD, FRCSC
Phone
613-737-8899
Ext
73019
Email
rbreau@ottawahospital.on.ca
First Name & Middle Initial & Last Name & Degree
Pascale Juneau, MASc
Phone
613-737-8899
Ext
73852
Email
pjuneau@ohri.ca
First Name & Middle Initial & Last Name & Degree
Rodney H Breau, MD
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
N/A. IPD not planned to be shared
Learn more about this trial
Impact of Hormonal Therapy on Prostate Cancer Recurrence After Radical Prostatectomy
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