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

Primary Purpose

Prostate Cancer, Biochemical Recurrence, Radiation

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Salvage radiation therapy
Sponsored by
Asan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

  • Asan Medical CenterRecruiting
  • Samsung Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Hypofractionated

Standard

Arm Description

65 Gy/ 26 fractions (fraction size 2.5 Gy)

66 Gy/ 33 fractions (fraction size 2 Gy)

Outcomes

Primary Outcome Measures

Biochemical recurrence-free survival
PSA >0.2 ng/mLfollowed by a repeat measurement >0.2 ng/mL

Secondary Outcome Measures

Acute toxicities
Evaulation using CTCAE 4.0 Evaluation using CTCAE 4.0 CTCAE 4.0
Chronic toxicities
Evaulation using CTCAE 4.0
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.
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.

Full Information

First Posted
March 25, 2019
Last Updated
January 15, 2021
Sponsor
Asan Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03920033
Brief Title
Salvage Hypofractionated Accelerated Versus Standard Radiotherapy for Biochemical Failure After Prostatectomy
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
January 1, 2022 (Anticipated)
Study Completion Date
January 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Biochemical Recurrence, Radiation, Hypofractionation, Dose Escalation, Survival, Radiation Toxicity, Quality of Life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
288 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hypofractionated
Arm Type
Experimental
Arm Description
65 Gy/ 26 fractions (fraction size 2.5 Gy)
Arm Title
Standard
Arm Type
Active Comparator
Arm Description
66 Gy/ 33 fractions (fraction size 2 Gy)
Intervention Type
Radiation
Intervention Name(s)
Salvage radiation therapy
Intervention Description
Salvage radiation therapy for biochemical recurrence
Primary Outcome Measure Information:
Title
Biochemical recurrence-free survival
Description
PSA >0.2 ng/mLfollowed by a repeat measurement >0.2 ng/mL
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Acute toxicities
Description
Evaulation using CTCAE 4.0 Evaluation using CTCAE 4.0 CTCAE 4.0
Time Frame
Adverse effects occured during radiation therapy, and within 3 months after radiation therapy
Title
Chronic toxicities
Description
Evaulation using CTCAE 4.0
Time Frame
Adverse effects occured after 3 months since end of radiation therapy
Title
Quality of life 1
Description
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.
Time Frame
the date of enrollment, up to 1 week after radiation therapy, 6 months, every year until 5 years
Title
Quality of life 2
Description
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.
Time Frame
the date of enrollment, up to 1 week after radiation therapy, 6 months, every year until 5 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Young Seok Kim, M.D., Ph.D.
Phone
82 2 3010 5614
Ext
5614
Email
ysk@amc.seoul.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Yeon Joo Kim, M.D.
Phone
82 2 258 9243
Ext
9243
Email
kamea1004@naver.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Young Seok Kim, M.D., Ph.D.
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Young Seok Kim, M.D., Ph.D.
Phone
82 2 3010 5614
Ext
5614
Email
ysk@amc.seoul.kr
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Won Park, M.D., Ph.D.
Phone
82-2-3410-2616
Email
wonp68@skku.edu

12. IPD Sharing Statement

Citations:
PubMed Identifier
34674739
Citation
Park G, Kim YJ, Ahn H, Park W, Lee JS, Kim YS. Salvage hypofractionated accelerated versus standard radiotherapy for the treatment of biochemical recurrence after radical prostatectomy (SHARE): the protocol of a prospective, randomized, open-label, superiority, multi-institutional trial. Trials. 2021 Oct 21;22(1):728. doi: 10.1186/s13063-021-05708-5.
Results Reference
derived

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Salvage Hypofractionated Accelerated Versus Standard Radiotherapy for Biochemical Failure After Prostatectomy

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