Observational study on radiation therapy and hormone treatment for high-risk prostate cancer
PRospective Observational Study of STereotactic Body rAdiation Therapy With Androgen Deprivation Therapy for Organ-confined High-risk Prostate Cancer: the PROSTAR Trial
This study is testing whether combining a special type of radiation therapy with hormone treatment can help men with high-risk prostate cancer do better and have fewer side effects compared to regular radiation.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 49 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Istituto Clinico Humanitas Academic / other |
| Drugs / interventions | radiation |
| Locations | 3 sites (Bergamo, Bergamo and 2 other locations) |
| Trial ID | NCT06949254 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the effectiveness of Stereotactic Body Radiation Therapy (SBRT) combined with Androgen Deprivation Therapy (ADT) in patients with organ-confined high-risk prostate cancer. It aims to evaluate the outcomes of this treatment approach, particularly focusing on disease control and toxicity levels compared to conventional radiation therapy. Eligible participants include men over 18 years with specific high-risk factors for prostate cancer, and the study will monitor their responses to the treatment over time.
Who should consider this trial
Good fit: Ideal candidates for this study are men over 18 years old with histologically confirmed high-risk prostate adenocarcinoma and no evidence of metastases.
Not a fit: Patients with previous local radiation treatment of the prostate or those with active inflammatory bowel diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients with high-risk prostate cancer, potentially improving survival rates and quality of life.
How similar studies have performed: Other studies have shown promising results with similar approaches using SBRT for localized prostate cancer, indicating potential for success in this study.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \> 18 years * ECOG performance status ≤ 2 * Histologically proven prostate adenocarcinoma * High-risk group classification according to National Comprehensive Cancer Network (NCCN), defined by the presence of any one of the following high-risk factors: cT3-cT4 OR Grade Group 4 or Grade Group 5 OR PSA \>20 ng/mL * No pelvic nodal and distant metastases at staging with PSMA-PET * IPSS ≤ 15 (alpha blockers allowed) * Life expectancy of \> 5 years * Prostate volume ≤ 100 cc Exclusion Criteria: * Previous local radiation treatment of the prostate * Previous radiotherapy to the pelvis * Active Ulcerative Colitis or Crohn's Disease * Previous tumors unless disease free for a minimum of 5 years
Where this trial is running
Bergamo, Bergamo and 2 other locations
- Humanitas Gavazzeni — Bergamo, Bergamo, Italy (Not_yet_recruiting)
- Humanitas PIO X — Milan, Milan, Italy (Not_yet_recruiting)
- IRCCS Humanitas Research Hospital — Rozzano, Milan, Italy (Recruiting)
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.