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NOT YET RECRUITING
NCT06855589
PHASE3

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

Sponsor: Charles LeMoyne Hospital

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

400

Start Date

2025-03

Completion Date

2034-03

Last Updated

2025-03-04

Healthy Volunteers

No

Interventions

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

Locations (5)

Hôpital de Gatineau

Gatineau, Quebec, Canada

Hôpital Charles LeMoyne

Longueuil, Quebec, Canada

Hôpital Maisonneuve-Rosemont

Montreal, Quebec, Canada

Jewish General Hospital

Montreal, Quebec, Canada

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, Canada