Feasibility Trial of Single-Dose Radiotherapy for Localized Low and Intermediate Risk Pros
The goal of this study is to assess the feasibility of high-dose radiotherapy (Single-Dose Radiotherapy, SDRT) of 24 Gy in patients with localized low and intermediate risk prostate cancer using a special system of internal and external immobilization of the prostate gland. Patients eligible for this study are classifi
| Condition(s) | Prostate Cancer |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | The goal of this study is to assess the feasibility of high-dose radiotherapy (Single-Dose Radiotherapy, SDRT) of 24 Gy in patients with localized low and intermediate risk prostate cancer using a special system of internal and external immobilization of the prostate gland. Patients eligible for this study are classified according to the National Comprehensive Cancer Network (NCCN) guidelines as low or intermediate risk prostate cancer (Stage T1-T2c and/or Prostate Specific Antigen (PSA) level ≤20 ng/mL and/or Gleason score of ≤7). The study will examine the technical feasibility of image-guided volumetrically-modulated arc therapy (VMAT-IGRT) with an emphasis on normal tissue sparing and precision of radiation delivery using dedicated devices (an air-filled endorectal balloon and a Foley |
| Who can participate | 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 fro |
| Ages | 18 Years |
| Sex | Male |
| Lead sponsor | Branch Office of "Hadassah Medical Ltd" |
| Locations | Moscow, Russia |
| Start date | 2024-07-24 |
| NCT ID | NCT07112781 |
| Official listing | https://clinicaltrials.gov/study/NCT07112781 |