Impact of Hormonal Therapy on Prostate Cancer Recurrence After Radical Prostatectomy

Ottawa Hospital Research Institute

Status and phase: Enrolling; Phase 3

Conditions: Prostate Cancer

Treatments: Drug: Lupron Depot

Study type: Interventional

Funder types: Other

Identifiers

NCT05169112

Adjuvant ADT Pilot

Details and patient eligibility

About

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.

Enrollment: 72 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. undetectable PSA (<0.02 ng/ml) within 16 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 2 patient groups

Standard of Care

No Intervention group

Description:

Standard of Care

Standard of Care plus Androgen Deprivation Therapy (Lupron Depot)

Experimental group

Description:

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

Treatment:

Drug: Lupron Depot