Feasibility Trial of Single-Dose Radiotherapy for Localized Low and Intermediate Risk Prostate Cancer

Launched by BRANCH OFFICE OF "HADASSAH MEDICAL LTD" · Aug 2, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new way to treat certain types of prostate cancer using a single, high-dose session of radiation therapy. It focuses on men with localized prostate cancer that is considered low or intermediate risk, meaning the cancer hasn’t spread and has certain characteristics like a PSA level of 20 or less and a Gleason score of 7 or lower. The study aims to see if this treatment can be delivered precisely and safely by using special devices to keep the prostate still during radiation, helping protect nearby healthy tissues.

Men who join the study will receive this one-time radiation treatment, with some getting a slightly higher dose if their cancer shows a specific visible lesion. After treatment, participants will have regular check-ups for at least two years to monitor side effects and see how well the treatment works. To be eligible, patients must have confirmed prostate cancer within the specified risk groups, no signs of cancer spread, and a prostate size under 100 cc. This study offers a potential option for men looking for a shorter, targeted treatment with close follow-up to ensure safety and effectiveness.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Signed study specific informed consent form;
• • Histologic confirmation of adenocarcinoma of the prostate by biopsy;
• • Biopsy Gleason score ≤ 7;
• • Up to 6 months of previous hormonal therapy is allowed (but not required);
• • PSA ≤ 20 prior to hormone therapy (if given);
• • No direct evidence of regional or distant metastases after appropriate staging studies (CT, MRI, 68Ga-Prostate-Specific Membrane Antigen (PSMA) Positron emission tomography (PET) / CT)
• • Age ≥ 18;
• • Performance Status 0-2;
• • International Prostate Symptom Score (IPSS) must be ≤ 15 (alpha blockers allowed)
• • Computerized Tomography (CT) or Magnetic Resonance Imaging (MRI) or Ultrasound-based volume estimation of prostate gland ≤ 100 cc
• Exclusion Criteria:
• • Positive lymph nodes or metastatic disease from prostate cancer on imaging studies (CT, MRI, 68Ga-Prostate-Specific Membrane Antigen (PSMA) Positron emission tomography (PET) / CT);
• • Tumour Clinical stage T3 or T4 on MRI;
• • Gleason score \> 7;
• • PSA \> 20 ng/mL;
• • Previous pelvic radiotherapy;
• • Previous surgery for prostate cancer;
• • Recent transurethral resection of the prostate (TURP) (less than 3 months);
• • Previous hormonal therapy given for more than 6 months prior to therapy;
• • Prior invasive malignancy unless disease free for a minimum of 3 years;
• • Previous significant urinary obstructive symptoms;
• • Significant psychiatric illness;
• • Ultrasound or CT or MRI estimate of prostate volume \> 100 cc;
• • Severe, active co-morbidity.
• • Inability to fulfill all dosimetric criteria for target dose coverage and restrictions for the organs at risk according to study protocol;