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出境医 / 临床实验 / Salvage Hypofractionated Accelerated Versus Standard Radiotherapy for Biochemical Failure After Prostatectomy (SHARE)
Salvage Hypofractionated Accelerated Versus Standard Radiotherapy for Biochemical Failure After Prostatectomy (SHARE)
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Prostate Cancer Biochemical Recurrence Radiation Hypofractionation Dose Escalation Survival Radiation Toxicity Quality of Life | Radiation: Salvage radiation therapy | Not Applicable |
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 288 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | May 1, 2019 |
| Estimated Primary Completion Date : | January 1, 2022 |
| Estimated Study Completion Date : | January 1, 2027 |
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures :
- Biochemical recurrence-free survival [ Time Frame: 5 years ]PSA >0.2 ng/mLfollowed by a repeat measurement >0.2 ng/mL
Secondary Outcome Measures :
- 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
- Chronic toxicities [ Time Frame: Adverse effects occured after 3 months since end of radiation therapy ]Evaulation using CTCAE 4.0
- 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.
- 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.
Eligibility Criteria
| Ages Eligible for Study: | 20 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Contacts
| Contact: Young Seok Kim, M.D., Ph.D. | 82 2 3010 5614 ext 5614 | ysk@amc.seoul.kr | |
| Contact: Yeon Joo Kim, M.D. | 82 2 258 9243 ext 9243 | kamea1004@naver.com |
Locations
| Korea, Republic of | |
| Asan Medical Center | Recruiting |
| Seoul, Korea, Republic of | |
| Contact: Young Seok Kim, M.D., Ph.D. 82 2 3010 5614 ext 5614 ysk@amc.seoul.kr | |
| Samsung Medical Center | Recruiting |
| Seoul, Korea, Republic of | |
| Contact: Won Park, M.D., Ph.D. 82-2-3410-2616 wonp68@skku.edu | |
Sponsors and Collaborators
Asan Medical Center
Investigators
| Principal Investigator: | Young Seok Kim, M.D., Ph.D. | Asan Medical Center |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | March 25, 2019 | ||||||||
| First Posted Date ICMJE | April 18, 2019 | ||||||||
| Last Update Posted Date | January 20, 2021 | ||||||||
| Actual Study Start Date ICMJE | May 1, 2019 | ||||||||
| Estimated Primary Completion Date | January 1, 2022 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Biochemical recurrence-free survival [ Time Frame: 5 years ] PSA >0.2 ng/mLfollowed by a repeat measurement >0.2 ng/mL
|
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
|
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| Original Secondary Outcome Measures ICMJE |
|
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Salvage Hypofractionated Accelerated Versus Standard Radiotherapy for Biochemical Failure After Prostatectomy | ||||||||
| Official Title ICMJE | 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 | ||||||||
| 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 Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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| Condition ICMJE |
|
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| Intervention ICMJE | Radiation: Salvage radiation therapy
Salvage radiation therapy for biochemical recurrence
|
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
288 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | January 1, 2027 | ||||||||
| Estimated Primary Completion Date | January 1, 2022 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender ICMJE |
|
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| Ages ICMJE | 20 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
|
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| Listed Location Countries ICMJE | Korea, Republic of | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03920033 | ||||||||
| Other Study ID Numbers ICMJE | S2019-0154-0001 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||||||
| Responsible Party | Young Seok Kim, Asan Medical Center | ||||||||
| Study Sponsor ICMJE | Asan Medical Center | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| PRS Account | Asan Medical Center | ||||||||
| Verification Date | January 2021 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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