Actively Recruiting

Phase Not Applicable
Age: 18Years +
MALE
NCT07112781

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

Led by Branch Office of "Hadassah Medical Ltd" · Updated on 2025-08-13

30

Participants Needed

1

Research Sites

157 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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 catheter) that ensure target immobilization and reproducibility of prostate anatomical localization using a special external patient immobilization system, including patient placement on the patient transfer trolley, which allows patient transfer without removing the endorectal balloon and urinary catheter during all stages of simulation and treatment planning (MR, CT, Positron emission tomography (PET) / CT-simulation) and during the treatment session on the linear accelerator. Previously untreated patients with localized prostate cancer of the low risk and favorable intermediate risk (NCCN) groups will receive SDRT at a dose of 24 Gy. In patients from the unfavourable intermediate risk (NCCN) group with a visible dominant intraprostatic lesion (DIL), local escalation of the DIL dose to 30 Gy will be performed. Patients will be followed up at one week and one month after completion of treatment, then every 3 months for 24 months (+/- 4 weeks), and every 6 months thereafter. Evaluation of early and late adverse events will focus, although not exclusively, on the genitourinary and gastrointestinal toxicity, primarily the rectal toxicity. Serum prostate-specific antigen (PSA) levels will be determined according to the clinical follow-up schedule. Multiparametric magnetic resonance imaging (mpMRI) with intravenous contrast will be performed at baseline and at 6-, 12-, and 24-months post-intervention. Participants of the study will be followed up for at least 2 years after treatment.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed study-specific informed consent form
  • Histologic confirmation of prostate adenocarcinoma by biopsy
  • Gleason score 7 or less
  • Up to 6 months of prior hormonal therapy allowed
  • PSA level 20 ng/mL or less before hormonal therapy
  • No evidence of regional or distant metastases after imaging
  • Age 18 years or older
  • Performance status between 0 and 2
  • International Prostate Symptom Score 15 or less (alpha blockers allowed)
  • Prostate gland volume 100 cc or less measured by imaging
Not Eligible

You will not qualify if you...

  • Positive lymph nodes or metastatic prostate cancer on imaging
  • Tumor clinical stage T3 or T4 on MRI
  • Gleason score greater than 7
  • PSA level greater than 20 ng/mL
  • Previous pelvic radiotherapy
  • Previous prostate cancer surgery
  • Transurethral resection of the prostate within 3 months
  • Hormonal therapy longer than 6 months before treatment
  • Prior invasive malignancy unless disease-free for 3 years
  • Significant urinary obstructive symptoms
  • Severe psychiatric illness
  • Prostate volume greater than 100 cc
  • Severe active comorbidities
  • Unable to meet dosimetric criteria for target dose coverage and organ protection

AI-Screening

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Trial Site Locations

Total: 1 location

1

The Branch of Hadassah Medical LTD

Moscow, Russia, 121205

Actively Recruiting

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Research Team

S

Sergey Usychkin, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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