Salvage Hypofractionated Accelerated Versus Standard Radiotherapy for Biochemical Failure After Prostatectomy

Not Applicable

Recruiting

• Conditions: Radiation Toxicity; Prostate Cancer; Biochemical Recurrence; Dose Escalation; Survival; Quality of Life; Radiation; Hypofractionation
• Interventions: Radiation: Salvage radiation therapy

• Registration Number: NCT03920033
• Lead Sponsor: Asan Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-25
• Study First Submitted QC: 2019-04-17
• Study First Posted: 2019-04-18
• Study Start: 2019-05-01
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-15
• Last Update Posted: 2021-01-20
• Primary Completion: 2022-01-01
• Study Completion: 2027-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 288

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hypofractionated	Salvage radiation therapy	65 Gy/ 26 fractions (fraction size 2.5 Gy)
Standard	Salvage radiation therapy	66 Gy/ 33 fractions (fraction size 2 Gy)

Primary Outcome Measures

Name	Time	Method
Biochemical recurrence-free survival	5 years	PSA \>0.2 ng/mLfollowed by a repeat measurement \>0.2 ng/mL

Secondary Outcome Measures

Name	Time	Method
Quality of life 1	the date of enrollment, up to 1 week after radiation therapy, 6 months, every year until 5 years	Expanded prostate cancer index composite (EPIC) Questionnaire Korean version EPIC consists of 50 questions in total divided into four domains: bowel (14 questions), urinary (12 questions), sexual (13 questions), and hormonal aspects (13 questions).; Scores of each domain will be separately reported. Response options for each EPIC item form a Likert scale, and multi-item scale scores will be summed and transformed linearly to a 0-to-100 scale.; The higher the score, the higher the quality of life.
Chronic toxicities	Adverse effects occured after 3 months since end of radiation therapy	Evaulation using CTCAE 4.0
Quality of life 2	the date of enrollment, up to 1 week after radiation therapy, 6 months, every year until 5 years	European Organization for Research and Treatment Core Quality of Life Questionnaire (EORTC QLQ-C30) Korean version EORTC QLQ-C30 consists of 30 questions, and total score will be reported. Response options for each EPIC question form a Likert scale, and multi-item scale scores will be summed and transformed linearly to a 0-to-100 scale.; The higher the score, the higher the quality of life.
Acute toxicities	Adverse effects occured during radiation therapy, and within 3 months after radiation therapy	Evaulation using CTCAE 4.0 Evaluation using CTCAE 4.0 CTCAE 4.0

Trial Locations

Locations (2)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of