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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)
Clinically negative (N0) stage, as defined by pelvic-CT or pelvic-MRI within 4 months prior to consent
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.
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My recent scans show no cancer spread to pelvic lymph nodes.
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I was diagnosed with prostate cancer in the last 6 months.
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My recent scans show no cancer spread to my bones.
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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.
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
1,468 Previous Clinical Trials
484,282 Total Patients Enrolled
63 Trials studying Prostate Cancer
15,192 Patients Enrolled for Prostate Cancer
BayerIndustry Sponsor
2,237 Previous Clinical Trials
25,326,770 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible to enroll in this venture at present?

"As indicated by the records on clinicaltrials.gov, enrollment for this trial has been paused at present; it was initially posted on November 1st 2022 and last updated April 13th of that year. Nonetheless, there are over a thousand other trials accepting participants currently."

Answered by AI

Is this experiment unique among similar protocols?

"The first study of Radiation Therapy was conducted in 2012 by Ferring Pharmaceuticals and involved 41 patients. Following the initial trial, it obtained N/A drug approval, allowing for 53 current studies to be held across 848 cities and 45 nations."

Answered by AI

Has the FDA sanctioned radiation therapy for medical use?

"Our team at Power rated Radiation Therapy's safety a 2, since this is a Phase 2 trial with evidence for its safety but not yet effectiveness."

Answered by AI

Could you please provide an overview of historical investigations related to Radiation Therapy?

"Presently, there are 53 ongoing investigations into Radiation Therapy of which 16 have reached Phase 3. Of those trials, the vast majority can be found in Los Angeles but the treatment is being trialled at a total of 2680 sites across America."

Answered by AI

What is the current participant headcount for this medical experiment?

"This medical trial is no longer accepting participants. It was initially listed on November 1st 2022 and the most recent edit occurred April 13th 2022. If you are looking for alternative research opportunities, there are currently 1315 trials recruiting patients diagnosed with prostate cancer and 53 Radiation Therapy studies actively enrolling individuals at this time."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of Radiation Therapy in Combination With Darolutamide + Degarelix in Intermediate Risk Prostate Cancer
2024. "Study of Radiation Therapy in Combination With Darolutamide + Degarelix in Intermediate Risk Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04176081.
~139 spots leftby Dec 2028
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