Advanced radiation therapy for localized prostate cancer
Fractionated Stereotactic Ablative Body Radiotherapy (SBRT) With FOcal Dose Escalation on Dominant Lesion in Localized Prostate Cancer
This study is testing a new type of radiation therapy for men with localized prostate cancer to see if giving higher doses to the main tumor area in fewer sessions can improve treatment results while causing fewer side effects.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 27 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Fundación de Investigación Biomédica - Hospital Universitario de La Princesa Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Madrid) |
| Trial ID | NCT05919524 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of stereotactic ablative body radiotherapy (SBRT) combined with focal dose escalation targeting the dominant intraprostatic lesion (DIL) in patients with localized prostate adenocarcinoma. The approach aims to deliver higher radiation doses in fewer sessions, potentially improving local control of the cancer while minimizing side effects. Patients will undergo imaging to identify the DIL, and the treatment will focus on intensifying the dose to this area while preserving surrounding healthy tissue. The study hypothesizes that this method will enhance treatment efficacy without significantly increasing toxicity compared to standard treatments.
Who should consider this trial
Good fit: Ideal candidates include men with histologically confirmed localized prostate adenocarcinoma, specifically those with intermediate or high-risk disease and a visible DIL on mpMRI.
Not a fit: Patients with advanced prostate cancer (T3b-4 or M1), previous prostate surgery within the last 6 months, or unresolved urinary issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved local control of prostate cancer with fewer side effects for patients.
How similar studies have performed: Previous studies have shown promising results with SBRT and dose escalation strategies in prostate cancer, indicating potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologically confirmed adenocarcinoma of the prostate * Primary localized PCa, cN0 and cM0, intermediate or high-risk disease according to NCCN 2023 * Signed written informed consent for this study * T2-T3a clinical stage with visible DIL on mpMRI * ECOG 0-1 * Desirable prostate volume (not mandatory) \< 80 cc or \> 80 cc if urinary function is preserved and dosimetrically feasible * IPSS ≤ 18 (International Prostate Symptom Score) Exclusion Criteria: * Unresolved previous prostatitis, symptomatic urethral stenosis * Bilateral hip prosthesis * T3b-4 clinical stage or N1 * M1 (presence of distant metastases) * Previous surgery at the prostate level (Transurethral Resection of the Prostate) within the last 6 months
Where this trial is running
Madrid
- La Princesa University Hospital, Health Research Institute, Madrid — Madrid, Spain (Recruiting)
Study contacts
- Study coordinator: Almudena Zapatero, PhD
- Email: almudena.zapatero@salud.madrid.org
- Phone: +34915202315
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.