NCT06855589

Optimal Duration of Hormonal Therapy for Unfavorable Intermediate-risk Prostate Cancer Patients: 6 Versus 12 Months.

Phase III Study of Hypofractionated, Dose Escalation Radiotherapy and Brachytherapy for Intermediate-risk Adenocarcinoma of the Prostate with 6 Versus 12 Months of Hormonal Manipulation

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Charles LeMoyne Hospital · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Patients with unfavorable intermediate-risk prostate cancer will be randomized between 6 versus 12 months of hormone therapy with radiation therapy. Patients may choose to receive hypofractionated radiation therapy or hypofractionated radiation therapy with high-dose rate brachytherapy. Hypofractionated radiation therapy refers to radiation therapy given fewer treatments, however higher doses per treatment.

Detailed description

A total of 400 patients with unfavorable intermediate-risk prostate cancer will be randomized into 2 arms: The first arm will receive the standard 6-month duration of hormone therapy with concomitant radiation therapy. The second arm will receive 12 months with concomitant radiation therapy. Radiation treatment will consist of either concomitant prostate SBRT to a dose of 40 Gy/5fractions over 2 weeks or a combination of external beam radiotherapy dose of 25 Gy in 5 fractions with a high-dose rate brachytherapy boost of 15 Gy. The choice of radiation treatment will be to the investigator's discretion..Patients will be stratified according to the number of intermediate-risk factors and according to the radiation therapy type.

Conditions

• Prostate Cancer (Adenocarcinoma)

Interventions

Type	Name	Description
DRUG	6 months of Eligard	Total of two 3-month injections of a LHRH agonist for total duration of 6 months
DRUG	12 months of Eligard	Total of four 3-month injections of a LHRH agonist for total duration of 12 months
RADIATION	prostate SBRT or prostate brachytherapy with radiation therapy	Patients may receive prostate stereotactic body radiation therapy or a combination of high-dose rate brachytherapy with radiation therapy; as per the treating physician's preference

Timeline

• Start date: 2025-03-01
• Primary completion: 2033-03-01
• Completion: 2034-03-01
• First posted: 2025-03-04
• Last updated: 2025-03-04

Locations

5 sites across 1 country: Canada