Salvage Moderate Hypofractionated Versus Ultrahypofractionated Radiotherapy for Biochemical Recurrence After Radical Prostatectomy in Prostate Cancer

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)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CRIS

Registry ID

KCT0011741

Enrollment

612

Registered

2026-03-18

Start date

2026-03-06

Completion date

Unknown

Last updated

2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

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). Ultra-hypofractionat

Eligibility

Sex/Gender

Male

Inclusion 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

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.)

Design outcomes

Primary

Measure	Time frame
5-year biochemical progression-free survival (bPFS)	—

Secondary

Measure	Time frame
Analyze Distant Metastasis-Free Survival (DMFS);Cancer-Specific Survival (CSS);Overall Survival (OS);Compare acute and late Genitourinary (GU) and Gastrointestinal (GI) toxicities.;Compare patient-reported Quality of Life (QoL) outcomes	—

Countries

Korea, Republic of

Contacts

Public ContactSeoha Choi

Samsung Medical Center

seoha1368@google.com+82-2-2148-7151

Outcome results