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Hormone Therapy

Hormone Therapy + Radiation for Prostate Cancer (PCS IV Trial)

Phase 3

Waitlist Available

Led By Abdenour Nabid, MD

Research Sponsored by Université de Sherbrooke

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

PCS IV Trial Summary

This trial is testing a shorter duration of hormone therapy for prostate cancer, to see if it is effective and has fewer side effects.

Who is the study for?

Men with high-risk prostate cancer who have a tumor classified as T3 or T4, Gleason score of 8-10, or PSA level >20. They must be in good physical condition (performance status 0-1), without distant metastasis or regional disease, and no progression of any previous cancers for over five years. Participants can have had up to two months of hormonal therapy before joining.Check my eligibility

What is being tested?

The trial is testing if an 18-month course of androgen blockade combined with pelvic irradiation is as effective as the standard three-year treatment for improving survival rates in high-risk prostate cancer patients. It will also assess quality of life and side effects related to the duration of hormone therapies.See study design

What are the potential side effects?

Potential side effects include those associated with long-term hormone therapy such as hot flashes, sexual dysfunction, bone thinning, mood changes, fatigue, and possibly increased risk for other health issues like heart disease.

PCS IV Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 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

Overall survival

Specific survival

Treatment morbidity induced versus quality of life based on duration of hormonal therapy

Secondary outcome measures

Disease-free survival

Interval until first biochemical failure

Interval until second biochemical failure during salvage androgen suppression (hormone-resistant tumour)

+1 more

PCS IV Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm 2 : 18 months AB + RTExperimental Treatment1 Intervention

Androgen blockade 18 months : bicalutamide 50 mg die for one month, goserelin 10.8 mg x 6 Q 3 months + radiation therapy ( pelvis 44 grays , prostate 70 grays ,2 grays/fraction)

Group II: Arm 1 : 36 months AB + RTActive Control1 Intervention

Androgen blockade : 36 months of androgen blockade : bicalutamide 50 mg die for one month, goserelin 10.8 mg x 12 Q 3 months + radiation therapy : pelvis 44 grays , prostate 70 grays (2 grays/fraction)

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Université de SherbrookeLead Sponsor

292 Previous Clinical Trials

68,811 Total Patients Enrolled

1 Trials studying Prostate Cancer

376 Patients Enrolled for Prostate Cancer

AstraZenecaIndustry Sponsor

4,265 Previous Clinical Trials

288,604,652 Total Patients Enrolled

59 Trials studying Prostate Cancer

26,892 Patients Enrolled for Prostate Cancer

Abdenour Nabid, MDPrincipal InvestigatorCentre de Recherche Clinique Étienne LeBel/CHUS Fleurimont

1 Previous Clinical Trials

600 Total Patients Enrolled

1 Trials studying Prostate Cancer

600 Patients Enrolled for Prostate Cancer

Media Library

Androgen Blockade (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT00223171 — Phase 3

Prostate Cancer Research Study Groups: Arm 1 : 36 months AB + RT, Arm 2 : 18 months AB + RT

Prostate Cancer Clinical Trial 2023: Androgen Blockade Highlights & Side Effects. Trial Name: NCT00223171 — Phase 3

Androgen Blockade (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00223171 — Phase 3

Frequently Asked Questions

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

Could you tell me if this clinical trial is open to patients who are not yet adults?

"To be included in this study, patients must 18 to 80 years old. There are currently 80 trials enrolling minors and 1358 clinical studies for adults aged 65 and older."

Answered by AI

Are patients currently being enrolled in this clinical trial?

"Indeed, this study is not currently looking for participants. However, it is worth mentioning that there are 1364 other trials with open recruitment at the present time. This particular trial was posted on October 1st 2000 and was last updated on May 20th 2022."

Answered by AI

What are the requirements to sign up for this experiment?

"Up to 630 people with prostate cancer between the ages of 18 and 80 can participate in this trial. Participants must have a Performance status score of 0-1, be free of distant metastasis, and have a negative bone scan 12 weeks prior to randomization. Additionally, hormonal therapy is allowed up to two months before signing the consent form as long as the initial work-up was done--including meeting all requested deadlines. Finally, patients must be available for treatments and follow-up visits, have a tumor classified T3 or T4, Gleason score 8-10, and sign a consent form before the start of the study. A"

Answered by AI

How does the addition of Androgen blockade to radiation therapy affect patient safety?

"Androgen blockade + radiation therapy is considered safe according to our team's 3-point scale. This is because it has reached Phase 3 clinical trials, so there is some data supporting both its efficacy and safety."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Duration of Androgen Blockade Combined With Pelvic Irradiation in Prostate Cancers

Abdenour Nabid 2000. "Duration of Androgen Blockade Combined With Pelvic Irradiation in Prostate Cancers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00223171.

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