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NCT Number: NCT05169112

Impact of Hormonal Therapy on Prostate Cancer Recurrence After Radical Prostatectomy

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.

Recruiting

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Nova Scotia Health, Halifax, Nova Scotia, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Rate of enrolment

    Time frame: 1 year

    Rate (patients/month) of enrolment

Secondary outcomes

  1. Rate of enrolment per site

    Time frame: 1 year

    Rate (patients/month) of enrolment per site

  2. Proportion of patients completing study intervention per-protocol

    Time frame: 1 year

    Proportion of patients completing study intervention per-protocol

  3. Time to study start-up

    Time frame: 1 year

    Time to study start-up at each site

  4. Completeness of study assessments

    Time frame: 1 year

    Proportion of study assessments completed per-protocol

Study contacts

Contact information is provided by the study sponsor or research team.

Rodney Breau, Dr.

CONTACT

[email protected]

613-737-8899 ext. 73019

Sponsors and collaborators

Lead sponsor

Ottawa Hospital Research Institute

Other

Collaborators

  • Tolmar Pharmaceuticals

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2028
First posted
Dec 23, 2021
Registry last updated
Mar 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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