NCT07500701

Brief Summary

This study is the first prospective, randomized phase III clinical trial designed to evaluate whether ultrahypofractionated radiotherapy is non-inferior to conventionally moderately hypofractionated radiotherapy in terms of efficacy, with acceptable toxicity, in patients who develop biochemical recurrence following radical prostatectomy. Considering the potential clinical benefits of shorter treatment duration, cost reduction, and improved patient convenience, this study is expected to provide important evidence to optimize salvage radiotherapy strategies in routine clinical practice.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
270

participants targeted

Target at P25-P50 for phase_3 prostate-cancer

Timeline
104mo left

Started Mar 2026

Typical duration for phase_3 prostate-cancer

Geographic Reach
1 country

1 active site

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 Progress3%
Mar 2026Dec 2034

Study Start

First participant enrolled

March 6, 2026

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

March 23, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 30, 2026

Completed
8.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2034

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2034

Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

8.8 years

First QC Date

March 23, 2026

Last Update Submit

March 23, 2026

Conditions

Prostate Cancer

Keywords

Prostate CancerUltra-hypofractionated radiotherapy

Outcome Measures

Primary Outcomes (1)

  • 5-year biochemical progression-free survival (bPFS)

    5 years after treatment completion

Secondary Outcomes (5)

  • Analyze Distant Metastasis-Free Survival (DMFS)

    5 years after treatment completion

  • Cancer-Specific Survival (CSS)

    5 years after treatment completion

  • Overall Survival (OS)

    5 years after treatment completion

  • Compare acute and late Genitourinary (GU) and Gastrointestinal (GI) toxicities.

    5 years after treatment completion

  • Compare patient-reported Quality of Life (QoL) outcomes

    During treatment and follow-up

Study Arms (2)

Moderate hypofractionated radiotherapy (Moderate-hypoRT)

ACTIVE COMPARATOR
Radiation: Moderate hypofractionated radiotherapy (Moderate-hypoRT)

Ultra-hypofractionated radiotherapy (Ultra-hypoRT)

EXPERIMENTAL
Radiation: Ultra-hypofractionated radiotherapy (Ultra-hypoRT)

Interventions

Moderate hypofractionated radiotherapy (Moderate-hypoRT)RADIATION

Moderate hypofractionated radiotherapy (Moderate-hypoRT): 60 Gy in 24 fractions (administered once daily on weekdays, five times per week, over a total of 5-6 weeks).

Moderate hypofractionated radiotherapy (Moderate-hypoRT)
Ultra-hypofractionated radiotherapy (Ultra-hypoRT)RADIATION

Ultra-hypofractionated radiotherapy (Ultra-hypoRT): 31 Gy in 5 fractions (administered every other day, 2-3 times per week, over a total of 2 weeks).

Ultra-hypofractionated radiotherapy (Ultra-hypoRT)

Eligibility Criteria

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

You may qualify if:

  • Patients who have undergone radical prostatectomy for prostate cancer
  • Age ≥ 20 years
  • Persistent prostate-specific antigen (PSA) elevation after radical prostatectomy, defined as prostate-specific antigen (PSA) levels of 0.1-1.0 ng/mL with at least three consecutive increases
  • Patients who have undergone prostate-specific membrane antigen positron emission tomography/computed tomography (PSMA PET/CT) for evaluation of prostate-specific antigen (PSA) elevation
  • Good performance status (ECOG performance status 0-1)

You may not qualify if:

  • Radiologic or clinical evidence of gross local recurrence, lymph node metastasis, or distant metastasis, including findings on prostate-specific membrane antigen positron emission tomography/computed tomography (PSMA PET/CT), as determined by the treating physician
  • Presence of lymph node metastasis or distant metastasis at the time of radical prostatectomy
  • History of prior pelvic radiotherapy
  • Diseases associated with a high risk of radiation toxicity (e.g., inflammatory bowel disease, systemic lupus erythematosus, scleroderma, or other connective tissue diseases)
  • History of another malignancy diagnosed or recurrent within the past 3 years (except for skin cancer and thyroid cancer)
  • Uncontrolled acute or chronic conditions deemed inappropriate for study participation by the investigator (e.g., dementia, Alzheimer's disease, cerebral infarction, etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, Gangnam-gu, 06351, South Korea

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Won Park

CONTACT

+82-10-9933-2616wonro.park@samsung.com

Study Design

Study Type
interventional
Phase
phase 3
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 23, 2026

First Posted

March 30, 2026

Study Start

March 6, 2026

Primary Completion (Estimated)

December 31, 2034

Study Completion (Estimated)

December 31, 2034

Last Updated

March 30, 2026

Record last verified: 2026-03

Locations

KR(1)