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

January 15, 2021 updated by: Young Seok Kim, Asan Medical Center

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

288

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Young Seok Kim, M.D., Ph.D.
  • Phone Number: 5614 82 2 3010 5614
  • Email: ysk@amc.seoul.kr

Study Contact Backup

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Asan Medical Center
        • Contact:
          • Young Seok Kim, M.D., Ph.D.
          • Phone Number: 5614 82 2 3010 5614
          • Email: ysk@amc.seoul.kr
      • Seoul, Korea, Republic of
        • Recruiting
        • Samsung Medical Center
        • Contact:
          • Won Park, M.D., Ph.D.
          • Phone Number: 82-2-3410-2616
          • Email: wonp68@skku.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hypofractionated
65 Gy/ 26 fractions (fraction size 2.5 Gy)
Radiation: Salvage radiation therapy
Salvage radiation therapy for biochemical recurrence
Active Comparator: Standard
66 Gy/ 33 fractions (fraction size 2 Gy)
Radiation: Salvage radiation therapy
Salvage radiation therapy for biochemical recurrence

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biochemical recurrence-free survival
Time Frame: 5 years
PSA >0.2 ng/mLfollowed by a repeat measurement >0.2 ng/mL
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute toxicities
Time Frame: 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
Adverse effects occured during radiation therapy, and within 3 months after radiation therapy
Chronic toxicities
Time Frame: Adverse effects occured after 3 months since end of radiation therapy
Evaulation using CTCAE 4.0
Adverse effects occured after 3 months since end of radiation therapy
Quality of life 1
Time Frame: 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.
the date of enrollment, up to 1 week after radiation therapy, 6 months, every year until 5 years
Quality of life 2
Time Frame: 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.
the date of enrollment, up to 1 week after radiation therapy, 6 months, every year until 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Investigators

  • Principal Investigator: Young Seok Kim, M.D., Ph.D., Asan Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2019

Primary Completion (Anticipated)

January 1, 2022

Study Completion (Anticipated)

January 1, 2027

Study Registration Dates

First Submitted

March 25, 2019

First Submitted That Met QC Criteria

April 17, 2019

First Posted (Actual)

April 18, 2019

Study Record Updates

Last Update Posted (Actual)

January 20, 2021

Last Update Submitted That Met QC Criteria

January 15, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S2019-0154-0001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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