Radiosurgery for treating non-metastatic prostate cancer
Technical Feasibility of a Randomized Pilot Study of Radiosurgery for the Treatment of Non-metastatic Prostate Cancer
This study is testing if a quicker type of radiation treatment for non-metastatic prostate cancer can be just as safe and effective as the standard treatment for patients based on their risk levels.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Pontificia Universidad Catolica de Chile Academic / other |
| Drugs / interventions | Radiation |
| Locations | 1 site (Santiago, Metropolitana) |
| Trial ID | NCT05123391 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to evaluate the feasibility of randomizing patients with non-metastatic prostate adenocarcinoma to different treatment schemes based on their risk levels. Patients will be categorized into risk groups as defined by the National Comprehensive Cancer Network and will receive stereotactic body radiotherapy (SBRT) or standard radiotherapy accordingly. The study will assess the effectiveness and safety of SBRT, which reduces treatment time compared to traditional methods. The goal is to provide a more convenient and effective treatment option for patients diagnosed with prostate cancer.
Who should consider this trial
Good fit: Ideal candidates include men diagnosed with prostate adenocarcinoma that is confined to the pelvis and who are eligible for curative radiotherapy.
Not a fit: Patients with metastatic prostate cancer or those with poor performance status (ECOG 2-4) may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a more efficient and less time-consuming treatment option for patients with non-metastatic prostate cancer.
How similar studies have performed: Previous studies have shown success with SBRT in treating low- and intermediate-risk prostate cancer, indicating that this approach is supported by existing evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histology confirmed prostate cancer * Disease confined to the pelvis by imaging CT (CT scan of chest, abdomen and pelvis and bone scan or prostate specific membrane antigen positron emission tomography (PET-PSMA) if required according to local guidelines) * Eastern Cooperative Oncology Group (ECOG) performance 0-1 * Eligible for curative radiotherapy Exclusion Criteria: * Metastasis beyond the pelvis * Poor performance ECOG 2-4 * Cannot follow directions to prepare for simulation (bladder filling and rectal emptying)
Where this trial is running
Santiago, Metropolitana
- Pontificia Universidad Catolica de Chile — Santiago, Metropolitana, Chile (Recruiting)
Study contacts
- Study coordinator: Tomas Merino, MD
- Email: tmerino@med.puc.cl
- Phone: 56-223543346
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.