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Recruiting NCT03920033

Salvage Hypofractionated Accelerated Versus Standard Radiotherapy for Biochemical Failure After Prostatectomy

No phase Interventional Prostate Cancer Biochemical Recurrence Radiation Hypofractionation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Salvage radiation therapy.
Who it may be relevant to
Registry conditions: Prostate Cancer, Biochemical Recurrence, Radiation, Hypofractionation. Basic parameters: from 20 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Radiation Salvage radiation therapy
    Salvage radiation therapy for biochemical recurrence

Primary outcome measures

  • Biochemical recurrence-free survival [Time frame: 5 years]
Secondary outcome measures (4)
  • Acute toxicities [Time frame: Adverse effects occured during radiation therapy, and within 3 months after radiation therapy]
  • Chronic toxicities [Time frame: Adverse effects occured after 3 months since end of radiation therapy]
  • Quality of life 1 [Time frame: the date of enrollment, up to 1 week after radiation therapy, 6 months, every year until 5 years]
  • Quality of life 2 [Time frame: the date of enrollment, up to 1 week after radiation therapy, 6 months, every year until 5 years]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

South Korea · 2 centers
  • Asan Medical Center — Seoul
  • Samsung Medical Center — Seoul

Publications

  • 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. PMID 34674739

Identifiers

NCT: NCT03920033 · S2019-0154-0001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗