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Radiation + Androgen Suppression for Prostate Cancer
Study Summary
This trial will compare the effectiveness of two treatments for prostate cancer.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I am 18 years old or older.I had a heart attack in the last 6 months.My prostate cancer has a Gleason score between 2 and 7, based on more than 6 biopsy samples.My PSA level is 20 ng/ml or lower, measured within the last 3 months.I can start treatment within 56 days of being chosen for the trial.My prostate symptoms are mild to moderate, with or without medication.My prostate cancer is at intermediate risk of coming back, confirmed by tests within the last year.I can start treatment within 56 days of being chosen for the trial.My pelvic lymph nodes are enlarged but have tested negative for cancer.I have had surgery for prostate cancer, including removal, heating, or freezing of the prostate.I have had radiation therapy for prostate cancer in the pelvic area.I have had hormone therapy for prostate cancer.I do not have active rectal issues like diverticulitis, Crohn's, or ulcerative colitis.I have had chemotherapy for prostate cancer before.I have had a blockage in my urethra that needed stretching.I am currently on blood thinners that cannot be stopped for tests or to manage side effects.My breast cancer is in an early stage and has not spread to lymph nodes or other parts of my body.My prostate is smaller than 55cc before starting active surveillance.I am fully active or restricted in physically strenuous activity but can do light work.I am 18 years old or older.You must complete all required pre-entry tests listed in section 4.0 within the specified time frames.My prostate symptoms are mild to moderate, scoring 21 or less on the IPSS.I haven't had any cancer besides skin cancer in the last 5 years.My prostate cancer is at intermediate risk of coming back, confirmed by tests within the last year.
- Group 1: Radiation Alone
- Group 2: Radiation + Androgen Suppression
- 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.
- 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.
Frequently Asked Questions
What is the maximum dosage of radiation that a patient can receive safely?
"Radiation has been studied relatively extensively, so it's been given a safety score of 3."
Are new participants being accepted into this clinical trial?
"Yes, that is accurate. The information hosted on clinicaltrials.gov supports that this trial is still recruiting patients. The original posting date was January 1st, 2012 and the data was last updated on October 24th, 2021. A total of 192 individuals are needed for the study across 6 sites."
What other similar medical trials have been conducted in the past?
"Radiation has been studied since the year 2000, when AstraZeneca first sponsored a trial of the medication. That initial study had 600 participants. After that Phase 3 drug approval was received in 2000, there are now 120 ongoing clinical trials for Radiation being conducted in 59 different nations and across 1596 cities."
What are the benefits of Radiation therapy?
"Radiation is an effective treatment for breast cancer, endometrial thinning, and other health concerns."
What is the body of research on Radiation like?
"The first scientific research on radiation was conducted in 2000 at Centre de Recherche Clinique du CHUS. In the two decades since, there have been a total of 331 completed trials. Right now, 120 live clinical trials are ongoing, with a notable concentration in Oklahoma City, Oklahoma."
At how many locations is this experiment being conducted?
"To make participation more convenient for patients, this clinical trial is being conducted at 6 different sites. These facilities are situated in Oklahoma City, Scottsdale, Warrenville and other locations."
What is the total number of people participating in this clinical trial?
"In order to run this clinical trial, we require 192 participants that fit the pre-specified inclusion criteria. Patients can travel to ProCure Proton Therapy Center in Oklahoma City, Oklahoma or Oklahoma Proton Center in Scottsdale, Arizona in order to take part."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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