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NCT Number: NCT07500701

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

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.

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Key information

Age range

20 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Samsung Medical Center

Seoul, Gangnam-gu, 06351, South Korea

Location status: Recruiting

Location contact

Samsung Medical Center

CONTACT

[email protected]

+82-2-3410-2616

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

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).

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).

Primary outcomes

  1. 5-year biochemical progression-free survival (bPFS)

    Time frame: 5 years after treatment completion

Secondary outcomes

  1. Analyze Distant Metastasis-Free Survival (DMFS)

    Time frame: 5 years after treatment completion

  2. Cancer-Specific Survival (CSS)

    Time frame: 5 years after treatment completion

  3. Overall Survival (OS)

    Time frame: 5 years after treatment completion

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

    Time frame: 5 years after treatment completion

  5. Compare patient-reported Quality of Life (QoL) outcomes

    Time frame: During treatment and follow-up

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study 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)

Important dates

Study start
2026
Primary completion
2034
Study completion
2034
First posted
Mar 30, 2026
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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