Single-dose 24 Gy radiotherapy for localized low- and intermediate‑risk prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial delivers a single 24 Gy fraction of external‑beam radiotherapy using VMAT with image guidance and a dedicated internal (air‑filled endorectal balloon and Foley catheter) and external patient immobilization system to hold the prostate steady. Treatment planning uses volumetric intensity‑modulated arc therapy with state‑of‑the‑art dosimetry and quality assurance to minimize dose to normal tissues. Eligible patients are men with biopsy‑proven localized prostate adenocarcinoma classified as low or intermediate risk by NCCN criteria, with prostate volume ≤100 cc and limited urinary symptoms. The study will record technical delivery parameters, normal‑tissue dose metrics, acute and late adverse events, and biochemical control outcomes over follow‑up.

Why it matters

Who can join: the full rules

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;

Where it's running

• The Branch of Hadassah Medical LTD
  Moscow, Russia Recruiting

Study contacts

• Principal investigator: Sergey Usychkin, MD — Chief Radiation Oncologist
• Study coordinator: Sergey Usychkin, MD
• Email: s.usychkin@hadassah.moscow
• Phone: +79166840574

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Targeted alpha therapy for B7-H3 expressing solid tumors using AKY-2519

  This phase 1b trial tests a radiolabeled drug (AKY-2519) to see if it's safe and tolerable in adults with B7-H3 positive advanced solid tumors, including NSCLC and SCLC, with imaging to help guide use.

  Recruiting at 2 sites Phase 1 Aktis Oncology, Inc. · Miami, Florida and 1 other locations · NCT07887971

• PSMA-guided surgery and tissue-resident T cells in node-positive prostate cancer

  This study tests whether PSMA-guided surgery can help identify and study tissue-resident T cells in prostate cancer that has spread to lymph nodes.

  Recruiting Niguarda Hospital · Milan, Lombardy · NCT07879820

• Predictive factors for response to Lu-177 PSMA therapy in metastatic castration-resistant prostate cancer

  This study tests whether imaging, dose measurements, and blood tests can predict which men with metastatic castration-resistant prostate cancer will respond to Lu-177 PSMA therapy.

  Recruiting Lithuanian University of Health Sciences · Kaunas · NCT07863986

• Salvage high-dose-rate brachytherapy for locally recurrent prostate cancer

  This observational study tests whether salvage HDR brachytherapy can help men with locally recurrent prostate cancer after initial radiotherapy, using advanced imaging and biopsy to guide treatment.

  Recruiting at 8 sites Instituto de Investigación en Oncología Radioterápica - Fundación Española de Oncología Radioterápic · Benidorm, Alicante and 9 other locations · NCT07860528

• Multi-peptide Vaccination and PSMAxCD3 Antibody Therapy for Prostate Cancer with Biochemical Recurrence

  This phase 2 trial tests whether a PSMA-targeted bispecific antibody (CC-1), a prostate cancer peptide vaccine (VAC-XS15-PC01), or both can be given safely and help control biochemical recurrence after local therapy in men with prostate cancer.

  Recruiting Phase 2 University Hospital Tuebingen · Heidelberg, Baden-Wurttemberg and 3 other locations · NCT07860047

• Lutetium-177 Ludotadipep for advanced prostate cancer

  This study tests whether adding Lu-177 Ludotadipep to standard care helps men with metastatic castration-resistant prostate cancer live longer without their disease getting worse.

  Recruiting at 7 sites Phase 3 FutureChem · Gyeonggi-do and 7 other locations · NCT07853209

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.