Clinical trial · Interventional
Salvage Hypofractionated Accelerated Versus Standard Radiotherapy for Biochemical Failure After Prostatectomy
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Patients with a biochemical recurrence after radical prostatectomy for moderate- or high- risk prostate cancer are randomly assigned to hypofractionated, accelerated high dose radiation therapy group (65 Gy, 26 fractions) and a control group of standard treatment group (66 Gy, 33 fractions). The criteria for stratification at randomization include 1) risk groups, 2) androgen deprivation therapy, and 3) PSA before salvage radiation therapy, which affect biochemical recurrence. It is expected that hypofractionated, accelerated high dose radiation therapy will have a superiority in terms of biochemical control to conventional radiation therapy, and the present study would like to confirm this. In addition, we aimed to evaluate and compare the toxicity and quality of life index of two radiation therapy regimens.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biochemical Recurrence | — | UNRESOLVED | — |
| Dose Escalation | — | UNRESOLVED | — |
| Hypofractionation | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Quality of Life | — | UNRESOLVED | — |
| Radiation | — | UNRESOLVED | — |
| Radiation Toxicity | — | UNRESOLVED | — |
| Survival | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Salvage radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Hypofractionated
- description
- 65 Gy/ 26 fractions (fraction size 2.5 Gy)
- interventionNames
- Radiation: Salvage radiation therapy
- type
- ACTIVE_COMPARATOR
- label
- Standard
- description
- 66 Gy/ 33 fractions (fraction size 2 Gy)
- interventionNames
- Radiation: Salvage radiation therapy
Primary outcomes (1)
- measure
- Biochemical recurrence-free survival
- timeFrame
- 5 years
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 20 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDPark G, Kim YJ, Ahn H, Park W, Lee JS, Kim YS. Salvage hypofractionated accelerated versus standard radiotherapy for the treatment of biochemical recurrence after radical prostatectomy (SHARE): the protocol of a prospective, randomized, open-label, superiority, multi-institutional trial. Trials. 2021 Oct 21;22(1):728. doi: 10.1186/s13063-021-05708-5. PMID 34674739