Impact of Hormonal Therapy on Prostate Cancer Recurrence After Radical Prostatectomy

NCT05169112 | Recruiting Phase 3 DMC

• 1 other identifier: Adjuvant ADT Pilot
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 3

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Rate of enrolment

  Rate (patients/month) of enrolment

  1 year

Secondary Outcomes (4)

• Rate of enrolment per site

  1 year

• Proportion of patients completing study intervention per-protocol

  1 year

• Time to study start-up

  1 year

• Completeness of study assessments

  1 year

Study Arms (2)

Standard of Care

NO INTERVENTION

Standard of Care

Standard of Care plus Androgen Deprivation Therapy (Lupron Depot)

EXPERIMENTAL

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

Drug: Lupron Depot

Interventions

Lupron Depot DRUG

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

Standard of Care plus Androgen Deprivation Therapy (Lupron Depot)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Unwilling to receive ADT;
• previously received ADT;
• lymph node metastases
• allergy to any form of ADT

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• Tolmar Pharmaceuticals: collaborator

Study Sites (3)

Nova Scotia Health

Halifax, Nova Scotia, B3H 2Y9, Canada

RECRUITING

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

RECRUITING

Centre universitaire de santé McGill - McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

NOT YET RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Leuprolide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Central Study Contacts

Rodney Breau, Dr.

CONTACT

613-737-8899; rbreau@toh.on.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: March 1, 2021
• First Posted: December 23, 2021
• Study Start: March 6, 2023
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2028
• Last Updated: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)