RecruitingNot ApplicableNCT04004312

Single Fractions SBRT for Prostate Cancer

Single Fractions SBRT in the Treatment of Prostate Cancer: A Phase I Study

Sponsor

Fabio Cury

Enrollment

12 participants

Start Date

Nov 7, 2018

Study Type

INTERVENTIONAL

Conditions

Prostate Cancer

Summary

It is a phase I study of radical hypofractionation delivering one single fraction of SBRT in patients with low- and favorable intermediate-risk prostate cancer that will undergo placement of the SpaceOAR hydrogel prior to treatment. Our hypothesis is that treatments can be safely delivered in one single fraction using SBRT provided the separation between the prostate and rectum is increased using the hydrogel

Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a single high-dose session of stereotactic body radiation therapy (SBRT) — a very precise form of targeted radiation — can effectively treat low-to-intermediate risk prostate cancer, potentially replacing the usual multi-week radiation schedule. **You may be eligible if...** - You are 18 or older - You have biopsy-confirmed prostate cancer (adenocarcinoma) - Your cancer is early-stage (T1-T2b) and your Gleason score is 6, 7(3+4), or 7(4+3) - Your PSA level is under 15 ng/mL (or under 10 ng/mL if Gleason is 7(4+3)) - Your urinary symptom score is low (IPSS < 16) and your prostate is not too large (under 80cc) - You are in good overall health **You may NOT be eligible if...** - You have high-risk or advanced prostate cancer - Your PSA is too high for this protocol - You have severe urinary symptoms that would be worsened by radiation - You have already had prostate treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONStereotactic Body Radiation Therapy (SBRT)

Shorter radiation therapy means that a higher dose will be offered. To limit side effects of exposure to a high dose, a medical device protecting the rectum will be used. The medical device to be used is called SpaceOAR hydrogel (device). The SpaceOAR hydrogel creates space between the rectum and the prostate, making it much less likely that the rectum is exposed to radiation. It is injected into place prior to the start of radiation treatment using a needle. Patients may be awake or asleep under local anesthesia for the procedure. SpaceOAR hydrogel is not painful, it remains stable during radiation therapy and then is gradually absorbed by the body over the course of approximately six months, once radiation therapy has been completed.