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HDR vs. LDR Brachytherapy for Prostate Cancer
Study Summary
This trial will offer men with intermediate risk prostate cancer the opportunity to be randomized between low dose rate brachytherapy and high dose rate brachytherapy. Men will also be offered the opportunity to test the aggressiveness of their cancer using Cell Cycle Progression Gene Profile.
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 fully active or can carry out light work.I have had radiation therapy to my pelvic area before.My prostate cancer is in an early stage, with low PSA and Gleason scores.I have a specific type of prostate cancer that is not considered low risk, and I haven't started any hormone therapy.I have had major surgery for prostate cancer.I have had surgery or cryotherapy for prostate issues.I have had chemotherapy for prostate cancer before.My prostate cancer is early stage, with specific PSA and Gleason scores.My prostate cancer is at an intermediate risk level, with specific PSA and Gleason scores.You feel uncomfortable in small spaces or cannot do an MRI.
- Group 1: Low dose rate brachytherapy
- Group 2: High dose rate brachytherapy
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
In order to participate in this trial, is it a requirement to be below a certain age limit?
"The age restrictions for this clinical trial are between 40 to 80 years old."
For which patients is this research project recruiting?
"This clinical trial is looking for 60 participants who have prostate cancer and are between the ages of 40 and 80. Participants must also meet the following criteria: Clinical stage T1c-T2b, PSA < 20, Gleason < 8, ECOG 0-1, Low tier intermediate-risk prostate cancer is defined by;, o a single NCCN intermediate risk factor (either Gleason 7(3+4) and PSA < 10 ng/ml OR Gleason 6 and PSA 10-20 ng/ml), clinical stage T1c-T2a, PSA < 10, Gleason"
Are new participants still being accepted into this trial program?
"That is correct, the information available on clinicaltrials.gov affirms that this clinical trial is recruiting patients. This specific trial was originally posted on 2016-05-01, and was updated on 2022-03-03. The trial is looking for 60 patients from 1 location."
How many test subjects are needed for this clinical trial?
"Yes, the information on clinicaltrials.gov says that this trial is actively looking for candidates. The trial was first posted on 2016-05-01 and was most recently updated on 2022-03-03. The clinical trial is searching for 60 participants between 1 sites."
What are some dangers associated with High Dose Rate prostate brachytherapy?
"Because this is a Phase 3 trial, there is some data supporting efficacy and multiple rounds of data supporting safety, so our team at Power estimates the safety of High Dose Rate prostate brachytherapy to be a 3."
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