Stereotactic radiation therapy for high-risk prostate cancer
Prostate SABR With Intra-Prostatic SABR Boost: A Phase II Study
This study is testing a new type of radiation therapy for men with high-risk prostate cancer to see if it can effectively treat the cancer while keeping patients safe.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | Male |
| Sponsor | King Saud University Academic / other |
| Drugs / interventions | Radiation |
| Locations | 1 site (Riyadh) |
| Trial ID | NCT04212715 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of Stereotactic Ablative Radiation (SABR) for treating high-risk prostate cancer. Patients will receive a total dose of 35 Gy in 5 weekly fractions to the prostate, with an additional intra-prostatic boost of up to 50 Gy to targeted nodules detected by MRI. The pelvic lymph nodes and seminal vesicles will also be treated with 25 Gy in 5 fractions. The goal is to evaluate the effectiveness and safety of this combined radiation approach.
Who should consider this trial
Good fit: Ideal candidates are men with histologically confirmed high-risk prostate adenocarcinoma.
Not a fit: Patients with prior pelvic radiotherapy or those with definitive extrapelvic nodal or distant metastatic disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve outcomes for patients with high-risk prostate cancer by providing a more targeted and effective radiation therapy.
How similar studies have performed: Other studies have shown promising results with SABR approaches in prostate cancer, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologically confirmed prostate adenocarcinoma * High-risk prostate cancer, defined as at least one of: T3, Gleason 8-10, OR PSA \> 20 ng/mL * Willing to give informed consent to participate in this clinical trial Exclusion Criteria: * Prior pelvic radiotherapy * Contraindication to radical prostate radiotherapy e.g. connective tissue disease or inflammatory bowel disease * Contraindication to prostate MRI * No evidence of castrate resistance (defined as PSA \< 3 ng/ml while testosterone is \< 0.7nmol/l. Patients could have been on combined androgen blockade but are excluded if this was started due to PSA progression. * Definitive extrapelvic nodal or distant metastatic disease on staging investigations.
Where this trial is running
Riyadh
- King Saud University Medical City — Riyadh, Saudi Arabia (Recruiting)
Study contacts
- Principal investigator: Yasir Alayed, MD — King Saud Medical City
- Study coordinator: Yasir Alayed, MD
- Email: yalayed@ksu.edu.sa
- Phone: +966114671546
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.