Single-dose image-guided radiotherapy for prostate cancer

Phase II Study of Single-Dose Image-Guided Radiotherapy (SDRT) With Urethral Sparing and Dose-Escalated Dominant Intraprostatic Lesion Simultaneous Integrated Boost for Intermediate-Risk Prostate Cancer (PROSINT II)

This study is testing a new type of one-time radiation treatment for men with low- or intermediate-risk prostate cancer to see if it works well and causes fewer side effects than standard treatments.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: Fundacao Champalimaud (other)
• Drugs / interventions: radiation
• Locations: 1 site (Lisbon)
• Trial ID: NCT04035642 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include men aged 18 and older with localized adenocarcinoma of the prostate classified as low or intermediate risk.

Not a fit: Patients with advanced prostate cancer, such as those with metastatic disease or high Gleason scores, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a more effective and less toxic option for patients with localized prostate cancer.

How similar studies have performed: Previous studies on extreme hypofractionation have shown promising results, indicating that this approach may be effective and safe.

Eligibility criteria

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 this trial is running

Lisbon

• Champalimaud Foundation — Lisbon, Portugal (RECRUITING)

Study contacts

• Principal investigator: Carlo Greco, MD — Fundacao Champalimaud
• Study coordinator: Carlo Greco, MD

Conditions: Prostate Cancer, prostate cancer, PSMA PET/scan, dose escalation, simultaneous integrated boost