RecruitingNot ApplicableNCT06027892

Two-fraction Versus Five-fraction Stereotactic Radiotherapy for Localized Prostate Cancer

Two-fraction Versus Five-fraction Stereotactic Radiotherapy for Localized Low- and Favorable Intermediate-risk Prostate Cancer: SABR-Dual


Sponsor

Rabin Medical Center

Enrollment

562 participants

Start Date

Dec 29, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to compare two dose schedules of stereotactic radiation therapy in patients with localized prostate cancer. Historically, external beam radiation to treat localized prostate cancer was given in small treatments over a period of multiple weeks. Recent studies have shown that with newer technologies and better understanding of how prostate cancer responds to radiation, the same effective dose can be given in as few as 5 treatments. This study is comparing this newer standard course of 5 treatments with an even shorter course of just 2 treatments. The dose for the 2 treatments is based on a form of internal radiation called brachytherapy, but in this study, that dose will be given using external radiation, without the need for invasive procedures. In order to make sure that the radiation therapy is given in a way that minimizes the risk of side effects to the surrounding organs, including the rectum and bladder, prior to radiation a hydrogel material will be inserted behind the prostate in order to distance the rectum further from the prostate gland, and small gold markers will be inserted into the prostate to decrease any possible movement during treatment. The main questions are whether 2-treatment radiation is tolerated as well and is as effective at treating prostate cancer, compared to the standard 5-treatment course of radiation.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two radiation therapy schedules for men with early-stage, low- or favorable intermediate-risk prostate cancer: receiving treatment in 2 sessions (fractions) versus 5 sessions using stereotactic body radiotherapy (SBRT) — a highly precise form of radiation. Fewer treatment sessions would be more convenient for patients if equally effective. **You may be eligible if...** - You are a man aged 18 or older - You have low-risk or favorable intermediate-risk prostate cancer (PSA below 20, Gleason score 6 or 7 with 3+4) - Your prostate gland is smaller than 60 cc - You have a urinary symptom score below 15 **You may NOT be eligible if...** - You have more advanced (unfavorable intermediate or higher) prostate cancer - You have had prior prostate cancer treatment or pelvic radiation - You have chronic inflammatory bowel disease, Crohn's disease, or a condition requiring ongoing immune suppression - You have a hip replacement or other contraindications to MRI - You had a TURP (prostate-clearing procedure) within the last 12 months 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

RADIATIONTwo-fraction stereotactic radiotherapy

Definitive prostate radiotherapy will be delivered to a dose biologically comparable to 40 Gy in 5 treatments, but in only 2 treatments

RADIATIONFive-fraction stereotactic radiotherapy

Definitive prostate radiotherapy will be delivered to a standard stereotactic dose of 40 Gy in 5 treatments


Locations(1)

Davidoff Cancer Center, Rabin Medical Center

Petah Tikva, Israel, Israel

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NCT06027892


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