Salvage Hypofractionated Accelerated Versus Standard Radiotherapy for Biochemical Failure After Prostatectomy

ClinicalTrials.gov ID

NCT03920033

Lead Sponsor

Asan Medical CenterOTHER

Overall Status

Recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

288Estimated

Last Update Posted

Jan 20, 2021Actual

Start Date

May 1, 2019Actual

Primary Completion Date

Jan 1, 2022Estimated

Completion Date

Jan 1, 2027Estimated

Official Title

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

Brief Summary

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.

• Prostate Cancer
• Biochemical Recurrence
• Radiation
• Hypofractionation
• Dose Escalation
• Survival
• Radiation Toxicity
• Quality of Life

• Salvage radiation therapy

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

Male

Accepts Healthy Volunteers

No

Eligibility 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

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Asan Medical CenterOTHER

wonp68@skku.edu82-2-3410-2616

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