Clinical trial NCT03920033: Salvage Hypofractionated Accelerated Versus Standard Radiotherapy for Biochemical Failure After Prostatectomy
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Biochemical Recurrence
Radiation
Hypofractionation
Dose Escalation
Survival
Radiation Toxicity
Quality of Life
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2019-04-18
Enrollment: 288
Sex: MALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Biochemical recurrence-free survival
timeFrame: 5 years
Secondary outcomes:
measure: Acute toxicities
timeFrame: Adverse effects occured during radiation therapy, and within 3 months after radiation therapy
measure: Chronic toxicities
timeFrame: Adverse effects occured after 3 months since end of radiation therapy
measure: Quality of life 1
timeFrame: the date of enrollment, up to 1 week after radiation therapy, 6 months, every year until 5 years
measure: Quality of life 2
timeFrame: the date of enrollment, up to 1 week after radiation therapy, 6 months, every year until 5 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Asan Medical Center
name: Young Seok Kim, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.