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

NCT06855589 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2025-03-04

No results posted yet for this study

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.

Conditions

  • Prostate Cancer (Adenocarcinoma)

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

Sponsors & Collaborators

  • Charles LeMoyne Hospital

    lead OTHER

Principal Investigators

  • Georges Wakil, MDCM, FRCPC, DABR · Hopital Charles Lemoyne

  • Tamim Niazi, MDCM, FRCPC · Jewish General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-31
Primary Completion
2033-03-31
Completion
2034-03-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06855589 on ClinicalTrials.gov