Single-dose image-guided radiotherapy for 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

This study evaluates the clinical outcomes and treatment-related toxicity of ultra-high single-dose external beam radiotherapy in patients with low- or intermediate-risk prostate cancer. Utilizing advanced computer-driven technology, the study implements single-dose image-guided radiotherapy (SD-IGRT) with a focus on accuracy and normal tissue sparing. Eligible patients will receive a single dose of 24 Gy using volumetric intensity-modulated arc radiotherapy (VMAT), with careful monitoring of treatment effects and side effects. The study aims to determine the safety and efficacy of this innovative treatment approach compared to traditional methods.

Why it matters

Who can join: the full rules

Inclusion criteria

Participants must meet all of the following criteria:

Signed study-specific informed consent form Histologic confirmation of adenocarcinoma of the prostate by biopsy Biopsy ISUP grade 1-3 Biopsy-proven localized intermediate-risk prostate cancer according to NCCN criteria No previous hormonal therapy PSA ≤20 ng/mL Staging multiparametric MRI confirmation of AJCC cT1c-cT2c disease, with no radiographic evidence of cT3, cT4, or N1 disease No direct evidence of regional or distant metastases after appropriate staging studies Age ≥18 years Performance status 0-2 IPSS score ≤15; alpha-blockers allowed CT- or ultrasound-based prostate gland volume estimate ≤100 grams

Exclusion criteria

Participants with any of the following are ineligible:

Positive lymph nodes or metastatic disease from prostate cancer on imaging studies MRI evidence of radiographic T3, T4, or N1 disease Biopsy ISUP grade ≥4 Previous pelvic radiotherapy Previous surgery for prostate cancer Previous transurethral resection of the prostate within 3 months Contraindication to protocol-required Foley catheter placement, rectal-balloon placement, MRI, PSMA PET/CT where required, or treatment immobilization/tracking procedures Active urinary tract infection, unresolved acute prostatitis, or other acute condition judged by the investigator to make simulation or SDRT unsafe until resolved Previous hormonal therapy History of Crohn's disease or ulcerative colitis Previous significant obstructive symptoms Significant psychiatric illness CT- or ultrasound-estimated prostate volume \>100 grams Severe active comorbidity judged by the investigator to preclude protocol treatment

Where it's running

• Champalimaud Foundation
  Lisbon, Portugal Recruiting

Study contacts

• Principal investigator: Carlo Greco, MD — Fundacao Champalimaud
• Study coordinator: Carlo Greco, MD
• Email: carlo.greco@fundacaochampalimaud.pt
• Phone: +351210480048

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.