Salvage Hypofractionated Accelerated Versus Standard Radiotherapy for Biochemical Failure After Prostatectomy

Prostate Cancer Clinical Trial

— SHARE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03920033
• Other study ID #: S2019-0154-0001
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: January 1, 2027

Study information

• Verified date: January 2021
• Source: Asan Medical Center
• Contact: Young Seok Kim, M.D., Ph.D.
• Phone: 82 2 3010 5614
• Email: ysk[@]amc.seoul.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 288
• Est. completion date: January 1, 2027
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Radiation:
• Salvage radiation therapy
Salvage radiation therapy for biochemical recurrence

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biochemical recurrence-free survival	PSA >0.2 ng/mLfollowed by a repeat measurement >0.2 ng/mL	5 years
Secondary	Acute toxicities	Evaulation using CTCAE 4.0 Evaluation using CTCAE 4.0 CTCAE 4.0	Adverse effects occured during radiation therapy, and within 3 months after radiation therapy
Secondary	Chronic toxicities	Evaulation using CTCAE 4.0	Adverse effects occured after 3 months since end of radiation therapy
Secondary	Quality of life 1	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.	the date of enrollment, up to 1 week after radiation therapy, 6 months, every year until 5 years
Secondary	Quality of life 2	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.	the date of enrollment, up to 1 week after radiation therapy, 6 months, every year until 5 years