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Hypofractionated Radiation Therapy + Eligard for Prostate Cancer (PROMPT Trial)
PROMPT Trial Summary
This trial is testing whether a new, more precise form of radiotherapy called MR-guided focal laser ablation (FLA) is more effective than the current standard of care for treating high-risk prostate cancer.
PROMPT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowPROMPT Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2019 Phase 4 trial • 107 Patients • NCT03035032PROMPT Trial Design
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Who is running the clinical trial?
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- I have a severe health condition that makes study treatments unsafe for me.I have received chemotherapy before or after surgery to remove my prostate.I had prostate surgery, my cancer hasn't spread to lymph nodes, and my PSA is rising but below 2.0 ng/ml.My blood counts meet the required levels for treatment.I had prostate surgery for high-risk cancer and my PSA is below 0.4 ng/ml.I've had a full physical and rectal exam in the last 90 days.I am 18 years old or older.I have had radiation therapy to my pelvic area before.I have been cancer-free for over 5 years, except for non-melanoma skin cancer.I have been treated with hormone therapy for cancer.I can carry out all my normal activities without help.
- Group 1: Post-op IMRT & hormonal therapy
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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
Is there still availability for individuals to join this medical experiment?
"Affirmative. Clinicaltrials.gov reports this clinical trial is currently recruiting; it was initially listed on September 3rd 2019 and the details were most recently updated August 31st 2021. 77 participants are needed from two different sites for this experiment."
What maladies are usually addressed with this therapeutic approach?
"This medicine is mainly used to treat advanced prostate cancer, but can also be prescribed for anemia and CPP (Central Precocious Puberty) as indicated by medical assessment."
What are the potential risks associated with this therapeutic approach?
"This experimental treatment is estimated to have a safety rating of 2, as the trial is currently in Phase 2. This implies that there are data available from prior studies confirming its safety but no evidence pointing towards efficacy yet."
Could you provide me with an overview of the other trials conducted in relation to this treatment?
"Currently, there are 64 trials exploring this treatment modality; 24 of which are in their final stage. Most studies related to this intervention take place in Duarte, California however 5355 sites have started research programs."
How many participants are allowed to be involved in this experimental endeavor?
"Affirmative. Clinicaltrials.gov detail that this trial, initially posted on September 3rd 2019, is currently enrolling patients for participation. A total of 77 individuals must be administered the medication across 2 different clinical sites."
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