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Impact of Hormonal Therapy on Prostate Cancer Recurrence After Radical Prostatectomy

Sponsor
Ottawa Hospital Research Institute (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05169112
Collaborator
(none)
40
Enrollment
2
Arms
72
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Lupron Depot
 Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Impact of Adjuvant Androgen Deprivation Following Radical Prostatectomy on Prostate Cancer Recurrence
Anticipated Study Start Date :
Mar 1, 2022
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Mar 1, 2028

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Standard of Care

Standard of Care
Experimental: Standard of Care plus Androgen Deprivation Therapy (Lupron Depot)

22.5 mg intra-muscular injection of Lupron Depot every 3 months for 12 months (4 injections total)

Drug: Lupron Depot
Patients randomized to receive androgen deprivation therapy (ADT) will receive 12 months of Lupron Depot (22.5 mg) administered every 3 months

Outcome Measures

Primary Outcome Measures

  1. Rate of enrolment [1 year]

    Rate (patients/month) of enrolment

Secondary Outcome Measures

  1. Rate of enrolment per site [1 year]

    Rate (patients/month) of enrolment per site

  2. Proportion of patients completing study intervention per-protocol [1 year]

    Proportion of patients completing study intervention per-protocol

  3. Time to study start-up [1 year]

    Time to study start-up at each site

  4. Completeness of study assessments [1 year]

    Proportion of study assessments completed per-protocol

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. undetectable PSA (<0.02 ng/ml) within 8 weeks post-operative;

  2. ≥25% predicted risk of PSA recurrence within 5 years of surgery (based on the Kattan nomogram)

Exclusion Criteria:

  1. Unwilling to receive ADT;

  2. previously received ADT;

  3. lymph node metastases

  4. allergy to any form of ADT

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Ottawa Hospital Research Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Rodney Breau, Dr., Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT05169112
Other Study ID Numbers:
  • Adjuvant ADT Pilot
First Posted:
Dec 23, 2021
Last Update Posted:
Dec 23, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Prostatic Neoplasms
Recurrence
Leuprolide

Study Results

No Results Posted as of Dec 23, 2021