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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

PCS III Trial 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.

PCS III 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

Interval before biochemical failure

Secondary outcome measures

Survival

Toxicity of irradiation

PCS III 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Abdenour NabidLead Sponsor

AstraZenecaIndustry Sponsor

4,262 Previous Clinical Trials

288,594,642 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

Media Library

Androgen Blockade (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT00223145 — Phase 3

Prostate Cancer Research Study Groups: Arm 1, Arm 3, Arm 2

Prostate Cancer Clinical Trial 2023: Androgen Blockade Highlights & Side Effects. Trial Name: NCT00223145 — Phase 3

Androgen Blockade (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00223145 — Phase 3

Frequently Asked Questions

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

Are the findings in this research unique?

"Androgen blockade has been an active area of research for over 20 years. The first study was completed in 2000 by AstraZeneca. After this initial Phase 3 600-person study, Androgen blockade received drug approval. As of today, there are 88 ongoing Androgen blockade trials being conducted in 1523 different cities across 60 countries."

Answered by AI

How is Androgen blockade commonly used in medical care?

"Androgen Blockade can be used to manage radiation therapy, palliative therapy, and endometrial thinning."

Answered by AI

Does this research include elderly people as participants?

"This clinical trial is available to patients that are between 18-80 years of age."

Answered by AI

Could I possibly qualify to help out with this research project?

"This clinical trial is looking for 600 people with prostate cancer aged 18-80 to participate. applicants must meet the following criteria: a) Patients with a previous history of cancer are eligible on the condition that they have been disease-free for more than five years, b) Patients with stage T1 or T2 untreated adenocarcinoma of the prostate, with a Gleason score that is less than or equal to 6, as well as a prostate-specific antigen (PSA) between 10-20 (intermediate risk) or patients with stage T1 or T2 untreated adenocarcinoma of the"

Answered by AI

Is there a high risk associated with Androgen blockade therapy?

"Androgen blockade is considered to be safe (scoring a 3 on our 1-3 scale) because it has reached Phase 3 in clinical trials. This means that there is some data supporting both its efficacy and safety."

Answered by AI

Androgen blockade has been a part of other clinical trials in the past, correct?

"As of now, there are 88 Androgen blockade clinical trials underway. Out of those, 35 are in Phase 3. Most of the Androgen blockade trials are taking place in Shijiazhuang, Hebei; however, there are 8838 locations running trials for this treatment globally."

Answered by AI

Recent research and studies

European Journal of CancerJournal

Androgen Deprivation Therapy and Radiotherapy in Intermediate-risk Prostate Cancer: A Randomised Phase III Trial

Nabid, Abdenour, Nathalie Carrier, Eric Vigneault, Thu Van Nguyen, Peter Vavassis, Marc-André Brassard, Boris Bahoric, et al.. 2021. “Androgen Deprivation Therapy and Radiotherapy in Intermediate-risk Prostate Cancer: A Randomised Phase III Trial”. European Journal of Cancer. Elsevier BV. doi:10.1016/j.ejca.2020.10.023.

clinicaltrials.govStudy

Study on the Role of Hormonal Treatment for Two Dosage Levels of Prostate Radiation Therapy Versus Prostate Radiation Therapy Alone

Abdenour Nabid 2000. "Study on the Role of Hormonal Treatment for Two Dosage Levels of Prostate Radiation Therapy Versus Prostate Radiation Therapy Alone". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00223145.

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