NCT03920033

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
288

participants targeted

Target at P75+ for not_applicable prostate-cancer

Timeline
8mo left

Started May 2019

Longer than P75 for not_applicable prostate-cancer

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress91%
May 2019Jan 2027

First Submitted

Initial submission to the registry

March 25, 2019

Completed
24 days until next milestone

First Posted

Study publicly available on registry

April 18, 2019

Completed
13 days until next milestone

Study Start

First participant enrolled

May 1, 2019

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Expected
Last Updated

January 20, 2021

Status Verified

January 1, 2021

Enrollment Period

2.7 years

First QC Date

March 25, 2019

Last Update Submit

January 15, 2021

Conditions

Prostate CancerBiochemical RecurrenceRadiationHypofractionationDose EscalationSurvivalRadiation ToxicityQuality of Life

Outcome Measures

Primary Outcomes (1)

  • Biochemical recurrence-free survival

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

    5 years

Secondary Outcomes (4)

  • Acute toxicities

    Adverse effects occured during radiation therapy, and within 3 months after radiation therapy

  • Chronic toxicities

    Adverse effects occured after 3 months since end of radiation therapy

  • Quality of life 1

    the date of enrollment, up to 1 week after radiation therapy, 6 months, every year until 5 years

  • Quality of life 2

    the date of enrollment, up to 1 week after radiation therapy, 6 months, every year until 5 years

Study Arms (2)

Hypofractionated

EXPERIMENTAL

65 Gy/ 26 fractions (fraction size 2.5 Gy)

Radiation: Salvage radiation therapy

Standard

ACTIVE COMPARATOR

66 Gy/ 33 fractions (fraction size 2 Gy)

Radiation: Salvage radiation therapy

Interventions

Salvage radiation therapyRADIATION

Salvage radiation therapy for biochemical recurrence

HypofractionatedStandard

Eligibility Criteria

Age20 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Asan Medical Center

Seoul, South Korea

RECRUITING

Samsung Medical Center

Seoul, South Korea

RECRUITING

Related Publications (1)

  • 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: 34674739DERIVED

MeSH Terms

Conditions

Prostatic NeoplasmsRadiation Injuries

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesWounds and Injuries

Study Officials

  • Young Seok Kim, M.D., Ph.D.

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

82 2 3010 5614ysk@amc.seoul.kr

Yeon Joo Kim, M.D.

CONTACT

82 2 258 9243kamea1004@naver.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 25, 2019

First Posted

April 18, 2019

Study Start

May 1, 2019

Primary Completion

January 1, 2022

Study Completion (Estimated)

January 1, 2027

Last Updated

January 20, 2021

Record last verified: 2021-01

Locations

KR(2)