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

NCT07112781 | Recruiting

• 1 other identifier: FAST-ONE
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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 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

Prostate Cancer

Keywords

Prostate Cancer; Radiotherapy

Outcome Measures

Primary Outcomes (3)

• Number of patients with treatment-related adverse events as assessed by Common Toxicity Criteria for Adverse Effects v4.0

  Assessment of treatment related adverse events as measured by Common Toxicity Criteria for Adverse Effects v4.0 over a 5 year time frame.

  2 years

• Concentration of serum PSA

  Changes of serum PSA after treatment

  2 years

• Biochemical relapse-free survival (bRFS)

  Biochemical relapse-free survival rate (Phoenix Definition)

  2 years

Secondary Outcomes (3)

• Expanded Prostate Cancer Index Composite (EPIC) Questionnaire to measure quality of life

  2 years

• International Index of Erectile Function (IIEF) Questionnaire to assess sexual function

  2 years

• Primary prostate tumor response based on multi-parametric MRI imaging

  2 years

Study Arms (1)

Single-Dose Radiotherapy (SDRT)

EXPERIMENTAL

Patients will be treated using image-guided, volumetric intensity-modulated arc radiotherapy (IGRT-VMAT) with emphasis on normal tissue sparing and delivery accuracy via the use of devices that ensure stability and beam location reproducibility. Patients will be treated with a single fraction at a prescription dose of 24 Gy. In patients in the unfavourable intermediate risk (NCCN) group with a visible dominant intraprostatic lesion (DIL), local dose escalation per DIL to 30 Gy will be performed.

Radiation: Single Dose Radiotherapy

Interventions

Single Dose Radiotherapy RADIATION

Procedure: external-beam radiotherapy (EBRT) on a linear accelerator with a dose 24 Gy in one session using technique of image-guided volumetric intensity modulation arc therapy (VMAT-IGRT) and a set of dedicated devices that ensure target immobilization and reproducibility of prostate anatomical localization during treatment. A special air-filled endorectal balloon will be used for immobilization of the prostate and anatomical reproducibility of organs at risk during treatment. A Foley catheter will be used to ensure reproducibility of the urethral position and online tracking of the prostate gland position during treatment. A special external immobilization system, including patient positioning on a patient transfer trolley, which allows for patient transfer without removing the endorectal balloon and urinary catheter from the table at all stages of pre-radiation preparation (MR, CT, Positron emission tomography (PET) / CT simulation) and during the treatment.

Single-Dose Radiotherapy (SDRT)

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Branch Office of "Hadassah Medical Ltd": lead

Study Sites (1)

The Branch of Hadassah Medical LTD

Moscow, 121205, Russia

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Sergey Usychkin, MD

  Chief Radiation Oncologist

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sergey Usychkin, MD

CONTACT

+79166840574; s.usychkin@hadassah.moscow

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2025
• First Posted: August 8, 2025
• Study Start: July 24, 2024
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)