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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

SChLAP/IDC Trial 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.Check my eligibility
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.See study design
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.

SChLAP/IDC Trial 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.
Select...
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.
Select...
My prostate cancer is considered to be at an intermediate risk level.

SChLAP/IDC Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Recurrence Free Survival
Secondary outcome measures
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 outcome measures
Incidence of treatment-emergent Adverse Events
Tolerability of Treatment

SChLAP/IDC Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Group 2: Radiation Therapy + darolutamide + degarelixExperimental Treatment3 Interventions
Participants randomized to Group 2 will receive radiation therapy only + darolutamide + degarelix.
Group II: Group 1: Radiation Therapy OnlyActive Control1 Intervention
Participants randomized to Group 1 will receive radiation therapy only.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiation Therapy
2017
Completed Phase 3
~7250
Darolutamide
2018
Completed Phase 2
~100
Degarelix
2002
Completed Phase 3
~3600

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,483 Previous Clinical Trials
486,314 Total Patients Enrolled
63 Trials studying Prostate Cancer
15,192 Patients Enrolled for Prostate Cancer
BayerIndustry Sponsor
2,247 Previous Clinical Trials
25,333,377 Total Patients Enrolled
38 Trials studying Prostate Cancer
25,711 Patients Enrolled for Prostate Cancer
Prostate Cancer CanadaOTHER
9 Previous Clinical Trials
7,318 Total Patients Enrolled
6 Trials studying Prostate Cancer
7,074 Patients Enrolled for Prostate Cancer

Media Library

Radiation Therapy Clinical Trial Eligibility Overview. Trial Name: NCT04176081 — Phase 2
Prostate Cancer Research Study Groups: Group 2: Radiation Therapy + darolutamide + degarelix, Group 1: Radiation Therapy Only
Prostate Cancer Clinical Trial 2023: Radiation Therapy Highlights & Side Effects. Trial Name: NCT04176081 — Phase 2
Radiation Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04176081 — Phase 2
~139 spots leftby Dec 2028
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