Prostate CancerPhase 3NCT07500701
Salvage Moderate Hypofractionated Versus Ultrahypofractionated Radiotherapy for Biochemical Recurrence After Radical Prostatectomy in Prostate Cancer
A Phase 3 study testing Moderate hypofractionated radiotherapy (Moderate-hypoRT) and Ultra-hypofractionated radiotherapy (Ultra-hypoRT) in people with Prostate Cancer, run by Samsung Medical Center at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Moderate hypofractionated radiotherapy (Moderate-hypoRT) and Ultra-hypofractionated radiotherapy (Ultra-hypoRT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 Mar 2026to 31 Dec 2034
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, Gangnam-gu, 06351
Samsung Medical Center, +82-2-3410-2616, wonro.park@samsung.com
About this study
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)
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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- Moderate hypofractionated radiotherapy (Moderate-hypoRT), Ultra-hypofractionated radiotherapy (Ultra-hypoRT)
- Keywords
- Prostate Cancer, Ultra-hypofractionated radiotherapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| Moderate hypofractionated radiotherapy (Moderate-hypoRT) | Active comparator | Not described Receives: Radiation: Moderate hypofractionated radiotherapy (Moderate-hypoRT) |
| Ultra-hypofractionated radiotherapy (Ultra-hypoRT) | Experimental | Not described Receives: Radiation: Ultra-hypofractionated radiotherapy (Ultra-hypoRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
5-year biochemical progression-free survival (bPFS)
Measured: 5 years after treatment completion
Secondary outcomes (5)
Analyze Distant Metastasis-Free Survival (DMFS)
Measured: 5 years after treatment completion
Cancer-Specific Survival (CSS)
Measured: 5 years after treatment completion
Overall Survival (OS)
Measured: 5 years after treatment completion
Compare acute and late Genitourinary (GU) and Gastrointestinal (GI) toxicities.
Measured: 5 years after treatment completion
Compare patient-reported Quality of Life (QoL) outcomes
Measured: During treatment and follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start6 Mar 2026
- Primary completion31 Dec 2034 (estimated)
- Study completion31 Dec 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Won Park, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07500701
- Sponsor's protocol ID
- SMC 2026-01-079
- Status last verified
- Mar 2026
- First submitted
- 23 Mar 2026
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07500701
- Acronym / sponsor ID
- SMC 2026-01-079
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Ultra-hypofractionated radiotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 6 Mar 2026 (actual)
- Primary completion
- 31 Dec 2034 (estimated)
- Study completion
- 31 Dec 2034 (estimated)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 20 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Moderate hypofractionated radiotherapy (Moderate-hypoRT) |
| 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). | Radiation | Ultra-hypofractionated radiotherapy (Ultra-hypoRT) |
Primary outcome
5-year biochemical progression-free survival (bPFS)
Time frame: 5 years after treatment completion
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Moderate hypofractionated radiotherapy (Moderate-hypoRT) and Ultra-hypofractionated radiotherapy (Ultra-hypoRT) in people with Prostate Cancer, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Won Park (+82-10-9933-2616, wonro.park@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5-year biochemical progression-free survival (bPFS) (time frame: 5 years after treatment completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.