Prostate Cancer Treatment Study: Preserving Nerves During Radiation Therapy
Sponsor: University of Texas Southwestern Medical Center
ClinicalTrials ID:NCT03525262
This study is exploring whether reducing radiation exposure to nerves during treatment can help maintain sexual function in men with localized prostate cancer, while still effectively treating the cancer.
Patient Parameters
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Program Overview
The study aims to find out if sparing the nerves around the prostate during a specific type of radiation therapy, called stereotactic ablative body radiotherapy (SAbR), can help men keep their sexual function. The study will also look at how well this approach controls the cancer and affects overall quality of life.
Description
This clinical trial is testing a new approach to treating localized prostate cancer by using a type of radiation therapy that aims to protect the nerves around the prostate. The goal is to see if this method can help men maintain their ability to have erections while still effectively treating the cancer. The study will compare the effects of this nerve-sparing technique to standard radiation therapy.
Participants will be randomly assigned to receive either the nerve-sparing radiation therapy or the standard treatment. Researchers will measure changes in sexual function and quality of life over two years. They will also monitor for any side effects related to the treatment and track the cancer's response.
The study will involve 120 men, with 60 in each treatment group. Participants will undergo various tests and evaluations to ensure they meet the study criteria and to monitor their progress throughout the trial.
Eligibility Criteria
Inclusion Criteria
- Men aged 18 years or older.
- Diagnosed with localized prostate cancer, specifically stages T1 or T2, without evidence of cancer spread.
- Good overall health with a performance status score of 0 to 2.
- A Gleason score of 7 or lower, indicating the cancer's aggressiveness.
- A baseline sexual function score between 60 and 100.
- A prostate-specific antigen (PSA) level of 20 ng/ml or lower.
- Prostate size of 80 grams or less, with possible medication to reduce size if over 60 grams.
- Willing and able to provide informed consent to participate in the study.
Exclusion Criteria
- Evidence of cancer spread beyond the prostate.
- Cancer too close to both nerve bundles around the prostate.
- High-risk prostate cancer with specific criteria.
- Inability to undergo necessary imaging tests.
- Previous treatment for prostate cancer, including surgery or radiation.
- Severe urinary symptoms or other significant health issues.
- Allergy to materials used in the study or uncontrolled bleeding disorders.
- Men who need medication or devices to achieve an erection.
- Men with significant penile abnormalities or implants.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| UCSF ( Department of Radiation Oncology University of California San Francisco) | 94143 | San Francisco | California |
| University of Colorado Hospital | 80045 | Aurora | Colorado |
| Penrose Hospital | 80907 | Colorado Springs | Colorado |
| University of Michigan- Michigan Medicine | 48109 | Ann Arbor | Michigan |
| Stony Brook University Cancer Center | 11794 | Stony Brook | New York |
| Cleveland Clinic | 44195 | Cleveland | Ohio |
| Penn Medicine Radiation Oncology | 19104 | Philadelphia | Pennsylvania |
| UT Southwestern Cancer Center | 75235 | Dallas | Texas |
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