Comparing two types of radiation therapy for prostate cancer recurrence after surgery
Comparison of Salvage Hypofractionated Accelerated Versus Standard Radiotherapy for Biochemical Recurrence After Radical Prostatectomy (SHARE Trial): a Prospective, Randomized Controlled, Open-label, Multi Center, Superiority Study
This study is testing whether a new type of radiation therapy works better than the standard treatment for men whose prostate cancer has come back after surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 288 (estimated) |
| Ages | 20 Years and up |
| Sex | Male |
| Sponsor | Asan Medical Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Seoul and 1 other locations) |
| Trial ID | NCT03920033 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of hypofractionated, accelerated high dose radiation therapy compared to standard radiation therapy in patients who have experienced biochemical recurrence of prostate cancer following radical prostatectomy. Participants will be randomly assigned to receive either 65 Gy in 26 fractions or 66 Gy in 33 fractions of radiation. The study aims to determine which treatment offers better biochemical control and to assess the associated toxicity and quality of life for patients. Stratification factors include risk groups, androgen deprivation therapy, and PSA levels prior to treatment.
Who should consider this trial
Good fit: Ideal candidates are men with intermediate- or high-risk prostate cancer who have experienced biochemical recurrence after radical prostatectomy.
Not a fit: Patients with clinically gross recurrent tumors, distant metastasis, or a history of pelvic irradiation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective radiation therapy option for patients with recurrent prostate cancer, potentially improving their long-term outcomes.
How similar studies have performed: Other studies have shown promising results with hypofractionated radiation therapy, suggesting potential benefits over standard approaches, but this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pathologically confirmed intermediate- or high-risk prostate cancer * Biochemical recurrence after radical prostatectomy (Definition: Serial elevation of PSA over 0.2 ng/mL and \<=1.0 ng/mL) * ECOG performance status 0-1 * Appropriate values of blood tests within 6 months after enrollment Absolute neutrophil count (ANC) ≥ 1500 cells/mm3 Platelets ≥ 50,000 cells/mm3 Hemoglobin ≥ 8.0 g/dl * Appropriate values of kidney function within 6 months after enrollment Creatinine \< 2.0 ng/dL * Appropriate values of liver function within 6 months after enrollment total bilirubin \< 1.5 X maximum normal value alanine aminotransferase or aspartate aminotransferase \< 2.5 X maximum normal value Exclusion Criteria: * Clinically gross recurrent tumor * Presence of distant metastasis * Presence of pelvic LN metastasis * History of pelvic irradiation * History of cryotherapy or brachytherapy for prostate cancer * Double primary cancer other than skin/thyroid cancer * Combined serious morbidity
Where this trial is running
Seoul and 1 other locations
- Asan Medical Center — Seoul, South Korea (Recruiting)
- Samsung Medical Center — Seoul, South Korea (Recruiting)
Study contacts
- Principal investigator: Young Seok Kim, M.D., Ph.D. — Asan Medical Center
- Study coordinator: Young Seok Kim, M.D., Ph.D.
- Email: ysk@amc.seoul.kr
- Phone: 82 2 3010 5614
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.