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Hormone Therapy
Hormone Therapy + Radiation for Prostate Cancer (PCS III Trial)
Phase 3
Waitlist Available
Led By Abdenour Nabid, MD
Research Sponsored by Abdenour Nabid
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 years
Awards & highlights
Summary
This trial would compare the results of two different doses of radiation therapy, given with or without hormone therapy, in order to determine which is more effective in reducing local failure rates.
Who is the study for?
Men with intermediate-risk prostate cancer, specifically untreated stage T1 or T2 adenocarcinoma of the prostate. Participants must have a Gleason score ≤7 and PSA levels within certain ranges. They should be disease-free from other cancers for over five years, able to attend treatments and follow-ups, and not have severe liver issues or medical/psychiatric conditions that could affect compliance.Check my eligibility
What is being tested?
The study is testing if six months of hormonal therapy (androgen blockade) can improve outcomes when combined with radiation therapy at two different doses (70 Gy and 76 Gy). It aims to see if hormonal treatment can reduce local failure rates like increasing radiation dose does, potentially offering more treatment options.See study design
What are the potential side effects?
Possible side effects include those related to hormone therapy such as fatigue, hot flashes, reduced sexual function, and potential bone thinning. Radiation may cause urinary symptoms like frequency or discomfort, bowel changes such as diarrhea, skin irritation in the treated area.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 10 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Interval before biochemical failure
Secondary outcome measures
Survival
Toxicity of irradiation
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Arm 2Experimental Treatment2 Interventions
Androgen blockade for 6 months + Radiotherapy 76 Gy
Group II: Arm 1Experimental Treatment2 Interventions
Androgen blockade for 6 months + Radiotherapy 70 Gy
Group III: Arm 3Active Control1 Intervention
Radiotherapy alone with 76 Gy
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Who is running the clinical trial?
Abdenour NabidLead Sponsor
AstraZenecaIndustry Sponsor
4,302 Previous Clinical Trials
288,623,999 Total Patients Enrolled
59 Trials studying Prostate Cancer
26,922 Patients Enrolled for Prostate Cancer
Abdenour Nabid, MDPrincipal InvestigatorCRC - CHUS
1 Previous Clinical Trials
630 Total Patients Enrolled
1 Trials studying Prostate Cancer
630 Patients Enrolled for Prostate Cancer
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Eligibility Criteria:
This trial includes the following eligibility criteria:- If you had cancer in the past, you can participate if you have been cancer-free for at least five years.You have severe medical or mental health issues that may make it difficult for you to follow the study requirements.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1
- Group 2: Arm 3
- Group 3: Arm 2
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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