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Radiation + Hormone Therapy for Prostate Cancer (SChLAP/IDC Trial)

Phase 2

Waitlist Available

Led By Neil Fleshner, MD

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

IR-PCa as per National Comprehensive Cancer Network (NCCN) criteria (PSA >10 and < 20 ng/mL and/or Gleason score 7 and/or T-category T2b-T2c clinical or ultrasound)

Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Must not have

Any cardiac events (e.g. unstable angina, myocardial infarction and/or congestive heart failure

Hemoglobin < 9.0 g/dL, independent of transfusion and/or growth factors, measured within 90 days prior to consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if adding a new hormone therapy to standard radiation therapy for prostate cancer will work better than standard therapy alone in men with a certain genetic marker and cancer cell arrangement.

Who is the study for?

Men over 18 with Intermediate-Risk Prostate Cancer (IR-PCa) who have not spread to bones, are in good enough health to perform daily activities, and have specific cancer cell arrangements or genetic markers. They must not have had prior prostate cancer treatments that affect the whole body, severe anemia, low platelets, poor kidney or liver function, be on blood thinners, or used hormonal therapies within a year.

What is being tested?

The study is testing if adding hormone therapy (Darolutamide and Degarelix) to standard radiation treatment improves outcomes for men with IR-PCa. Participants will either receive both treatments or just radiation in this phase 2 trial conducted across Canada. The treatment period lasts six months followed by five years of monitoring.

What are the potential side effects?

Possible side effects include hot flashes, fatigue, sexual dysfunction due to lower testosterone levels from hormone therapy; skin irritation from radiation; and potential allergic reactions to Darolutamide which is still experimental.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My prostate cancer is intermediate-risk with specific PSA levels, Gleason score, or tumor size.

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I am able to get out of my bed or chair and move around.

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I am a man aged 18 or older.

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My prostate cancer is considered to be at an intermediate risk level.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had recent heart problems like unstable angina, heart attacks, or heart failure.

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My hemoglobin level is below 9.0 g/dL without transfusions.

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I have not taken any hormone therapy for my condition in the last year.

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I am currently taking blood thinners for a health condition.

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I have received chemotherapy for prostate cancer.

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My kidney function is not normal, with high creatinine or low GFR.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Recurrence Free Survival

Secondary study objectives

Changes in prostate cancer-specific HRQoL as measured by SF-12 questionnaire, as a function of treatment assignment

Changes in prostate cancer-specific HRQoL as measured by abbreviated EPIC (urinary, bowel, sexual, and hormonal domains) questionnaire, as a function of treatment assignment

Difference in RFS rates (as defined in measure) between IDC/SChLAP1 and treatment groups.

+5 more

Other study objectives

Incidence of treatment-emergent Adverse Events

Tolerability of Treatment