Impact of Hormonal Therapy on Prostate Cancer Recurrence After Radical Prostatectomy

Prostate Cancer Clinical Trial

Official title:

The Impact of Adjuvant Androgen Deprivation Following Radical Prostatectomy on Prostate Cancer Recurrence

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05169112
• Other study ID #: Adjuvant ADT Pilot
• Status: Recruiting
• Phase: Phase 3
• Start date: March 6, 2023
• Est. completion date: November 2028

Study information

• Verified date: March 2023
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: November 2028
• Est. primary completion date: November 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms
• Recurrence

Intervention

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

Locations

Country	Name	City	State
Canada	The Ottawa Hospital	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of enrolment	Rate (patients/month) of enrolment	1 year
Secondary	Rate of enrolment per site	Rate (patients/month) of enrolment per site	1 year
Secondary	Proportion of patients completing study intervention per-protocol	Proportion of patients completing study intervention per-protocol	1 year
Secondary	Time to study start-up	Time to study start-up at each site	1 year
Secondary	Completeness of study assessments	Proportion of study assessments completed per-protocol	1 year