Salvage Moderate Hypofractionated Versus Ultrahypofractionated Radiotherapy for Biochemical Recurrence After Radical Prostatectomy in Prostate Cancer
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: Moderate hypofractionated radiotherapy (Moderate-hypoRT), Ultra-hypofractionated radiotherapy (Ultra-hypoRT).
- Who it may be relevant to
- Registry conditions: Prostate Cancer. 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 →
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Official title
Salvage Moderate Hypofractionated Versus Ultrahypofractionated Radiotherapy for Biochemical Recurrence After Radical Prostatectomy in Prostate Cancer: A Prospective, Multi-Center, Randomized Phase III Non- Inferiority Trial (HUB Trial)
Overview
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.
Detailed description
Moderate hypofractionated radiotherapy (Moderate-hypoRT): 60 Gy in 24 fractions, delivered once daily, 5 days per week (on weekdays), over a total of 5-6 weeks.
Ultra-hypofractionated radiotherapy (Ultra-hypoRT): 31 Gy in 5 fractions, delivered every other day (2-3 fractions per week), over a total of 2 weeks.
Interventions
- Radiation Moderate hypofractionated radiotherapy (Moderate-hypoRT)
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). - Radiation Ultra-hypofractionated radiotherapy (Ultra-hypoRT)
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).
Primary outcome measures
- 5-year biochemical progression-free survival (bPFS) [Time frame: 5 years after treatment completion]
Secondary outcome measures (5)
- Analyze Distant Metastasis-Free Survival (DMFS) [Time frame: 5 years after treatment completion]
- Cancer-Specific Survival (CSS) [Time frame: 5 years after treatment completion]
- Overall Survival (OS) [Time frame: 5 years after treatment completion]
- Compare acute and late Genitourinary (GU) and Gastrointestinal (GI) toxicities. [Time frame: 5 years after treatment completion]
- Compare patient-reported Quality of Life (QoL) outcomes [Time frame: During treatment and follow-up]
Eligibility criteria
Inclusion criteria
- 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)
Exclusion criteria
- 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.)
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 · 1 center
- Samsung Medical Center — Seoul
Identifiers
NCT: NCT07500701 · SMC 2026-01-079