Salvage Hypofractionated Accelerated Versus Standard Radiotherapy for Biochemical Failure After Prostatectomy (SHARE)

Asan Medical Center

Status: Enrolling

Conditions: Dose Escalation; Survival; Radiation Toxicity; Quality of Life; Radiation; Biochemical Recurrence; Hypofractionation; Prostate Cancer

Treatments: Radiation: Salvage radiation therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03920033

S2019-0154-0001

Details and patient eligibility

About

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.

Enrollment: 288 estimated patients

Sex: Male

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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288 participants in 2 patient groups

Hypofractionated

Experimental group

Description:

65 Gy/ 26 fractions (fraction size 2.5 Gy)

Treatment:

Radiation: Salvage radiation therapy

Standard

Active Comparator group

Description:

66 Gy/ 33 fractions (fraction size 2 Gy)

Treatment:

Radiation: Salvage radiation therapy