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Salvage Hypofractionated Accelerated Versus Standard Radiotherapy for Biochemical Failure After Prostatectomy

  • Clinicaltrials.gov identifier

    NCT03920033

  • Recruitment Status

    Recruiting

  • First Posted

    April 18, 2019

  • Last update posted

    January 20, 2021

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:Dose Escalation
    Prostate Cancer
    Survival
    Radiation Toxicity
    Quality of Life
    Radiation
    Biochemical Recurrence
    Hypofractionation
  • Intervention/Treatment: Radiation: Salvage radiation therapy
  • Phase: N/A

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • 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 2019
  • Estimated Primary Completion Date: January 2022
  • Estimated Study Completion Date: January 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: 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.

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
Seoul

Korea, Republic of
Samsung Medical Center
Seoul

Sponsors and Collaborators

Asan Medical Center

Investigators

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

More Information

  • Responsible Party: 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: January 20, 2021
  • Last Verified: January 2021
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Recurrence