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

Recruiting · NCT06027892 · Interventional (participants receive a specific treatment) · Lead sponsor: Rabin Medical Center

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PROSTATE CANCER

Interventions studied

Five-fraction stereotactic radiotherapyTwo-fraction stereotactic radiotherapy

What this trial is about

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.

Who can take part

Age range

18 Years and older

Sex

Male

Healthy volunteers

No - a diagnosis or condition is required

Phase

Not applicable (e.g. observational or device study)

Study type

Interventional (participants receive a specific treatment)

Eligibility criteria (as published)

Inclusion: * Male patients ≥18 years * Diagnosis of low- or favorable intermediate-risk prostate adenocarcinoma * T1-T2c * Prostate specific antigen \< 20 * Gleason 6 or 7 (3+4) * Cannot had multiple intermediate-risk factors consistent with unfavorable intermediate risk disease * Prostate gland \< 60 cc (can include following cytoreductive androgen deprivation) * International Prostate Symptom Score \< 15 (unaided by a-adrenergic inhibitor or anticholinergic drugs) Exclusion: * Unfavorable intermediate-risk disease and above * Chronic inflammatory bowel condition (IBD, Crohn's disease, Sarcoidosis, Rheumatic disease) * Chronic immunosuppression * Contraindications to hydrogel spacer placement * Contraindications to a prostate MRI * Any prior prostate cancer treatment * Prior pelvic radiotherapy * Previous transurethral resection of the prostate (TURP) within 12 months * Hip prosthesis * Prior use of therapeutic androgen deprivation therapy

Where it is running

1 location listed.

Davidoff Cancer Center, Rabin Medical Center - Petah Tikva, Israel, Israel

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →