NCT06027892 Two-fraction Versus Five-fraction Stereotactic Radiotherapy for Localized Prostate Cancer
| NCT ID | NCT06027892 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Rabin Medical Center |
| Condition | PROSTATE CANCER |
| Study Type | INTERVENTIONAL |
| Enrollment | 562 participants |
| Start Date | 2022-12-29 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 562 participants in total. It began in 2022-12-29 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Elisha T Fredman, MD
PRINCIPAL INVESTIGATOR
Davidoff Cancer Center, Rabin Medical Center
Frequently Asked Questions
Who can join the NCT06027892 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying PROSTATE CANCER. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06027892 currently recruiting?
Yes, NCT06027892 is actively recruiting participants. Contact the research team at elishafre@clalit.org.il for enrollment information.
Where is the NCT06027892 trial being conducted?
This trial is being conducted at Petah Tikva, Israel.
Who is sponsoring the NCT06027892 clinical trial?
NCT06027892 is sponsored by Rabin Medical Center. The principal investigator is Elisha T Fredman, MD at Davidoff Cancer Center, Rabin Medical Center. The trial plans to enroll 562 participants.
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