Impact of Hormonal Therapy on Prostate Cancer Recurrence After Radical Prostatectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lupron Depot.
- Who it may be relevant to
- Registry conditions: Prostate Cancer. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Impact of Adjuvant Androgen Deprivation Following Radical Prostatectomy on Prostate Cancer Recurrence
Overview
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.
Interventions
- 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
Primary outcome measures
- Rate of enrolment [Time frame: 1 year]
Secondary outcome measures (4)
- Rate of enrolment per site [Time frame: 1 year]
- Proportion of patients completing study intervention per-protocol [Time frame: 1 year]
- Time to study start-up [Time frame: 1 year]
- Completeness of study assessments [Time frame: 1 year]
Eligibility criteria
Inclusion criteria
- undetectable PSA (<0.02 ng/ml) within 16 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Canada · 3 centers
- Nova Scotia Health — Halifax
- The Ottawa Hospital — Ottawa
- Centre universitaire de santé McGill - McGill University Health Centre — Montreal
Identifiers
NCT: NCT05169112 · Adjuvant ADT Pilot