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NCT Number: NCT03920033

Salvage Hypofractionated Accelerated Versus Standard Radiotherapy for Biochemical Failure After Prostatectomy

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.

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Key information

Conditions

Prostate Cancer Biochemical Recurrence Dose Escalation Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Hypofractionation Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Quality of Life Radiation Radiation Injuries Radiation Toxicity Survival Urogenital Diseases Urogenital Neoplasms Wounds and Injuries

Age range

20 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Asan Medical Center, Seoul, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Salvage radiation therapy

Radiation

Salvage radiation therapy for biochemical recurrence

Primary outcomes

  1. Biochemical recurrence-free survival

    Time frame: 5 years

    PSA >0.2 ng/mLfollowed by a repeat measurement >0.2 ng/mL

Secondary outcomes

  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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yeon Joo Kim, M.D.

CONTACT

[email protected]

82 2 258 9243 ext. 9243

Young Seok Kim, M.D., Ph.D.

CONTACT

[email protected]

82 2 3010 5614 ext. 5614

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Official study 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

Acronym: SHARE

Important dates

Study start
2019
Primary completion
2022
Study completion
2027
First posted
Apr 18, 2019
Registry last updated
Jan 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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