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

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ClinicalTrials.gov Identifier: NCT03920033
Recruitment Status : Not yet recruiting
First Posted : April 18, 2019
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
Young Seok Kim, 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.


Condition or disease Intervention/treatment Phase
Prostate Cancer Biochemical Recurrence Radiation Hypofractionation Dose Escalation Survival Radiation Toxicity Quality of Life Radiation: Salvage radiation therapy Phase 3

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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
Estimated Study Start Date : May 1, 2019
Estimated Primary Completion Date : April 1, 2022
Estimated Study Completion Date : April 1, 2027

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




Primary Outcome Measures :
  1. Biochemical recurrence-free survival [ Time Frame: 5 years ]
    PSA >0.2 ng/mLfollowed by a repeat measurement >0.2 ng/mL


Secondary Outcome Measures :
  1. 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

  2. Chronic toxicities [ Time Frame: Adverse effects occured after 3 months since end of radiation therapy ]
    Evaulation using CTCAE 4.0

  3. 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.


  4. 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.




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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03920033


Contacts
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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

Sponsors and Collaborators
Asan Medical Center
Investigators
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Principal Investigator: Young Seok Kim, M.D., Ph.D. Asan Medical Center

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Responsible Party: Young Seok Kim, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT03920033     History of Changes
Other Study ID Numbers: S2019-0154-0001
First Posted: April 18, 2019    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Recurrence
Disease Attributes
Pathologic Processes