Hormone Therapy Duration for Prostate Cancer
(PCS-XII Trial)

Recruiting in Palo Alto (17 mi)

+4 other locations

Overseen byTamim Niazi, MDCM, FRCPC

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Charles LeMoyne Hospital

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Georges Wakil, MDCM, FRCPC, DABR

Principal Investigator

Hopital Charles Lemoyne

Tamim Niazi, MDCM, FRCPC

Principal Investigator

Jewish General Hospital

Eligibility Criteria

This trial is for men with a specific stage of prostate cancer called 'unfavorable intermediate-risk.' They should be fit for hormone therapy and radiation, which could include high-dose brachytherapy. Specific details on who can or cannot participate are not provided here.

Inclusion Criteria

Adequate birth control measures must be used by participants or their sexual partners

My recent scans show no cancer in my pelvic or para-aortic lymph nodes.

I started hormone therapy for cancer less than 28 days ago.

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Exclusion Criteria

Presence of bilateral hip replacement prostheses

I have a heart condition called long QT syndrome or take certain heart medications.

Known hypersensitivity to any protocol-indicated study medications

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Treatment Details

Interventions

Eligard (Hormone Therapy)
Prostate SBRT or Prostate Brachytherapy with Radiation Therapy (Radiation)

Trial OverviewThe study is testing the length of hormone therapy needed when combined with radiation treatment. Men will either receive 6 months or 12 months of Eligard, a hormonal drug, alongside their chosen form of radiation therapy.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: 12 months of hormone therapyExperimental Treatment2 Interventions

Patients will receive a total of four 3-month injections of a LHRH agonist

Group II: 6 months of hormone therapyActive Control1 Intervention

Patients will receive a total of two 3-month injections of a LHRH agonist