Prostate AdenocarcinomaNCT07888283
SURPASS: Stereotactic Ultra-hypofractionated Radiotherapy for Post-prostatectomy Patients: Adaptive Salvage SBRT
A study testing Adaptive stereotactic body radiotherapy (SBRT) in people with Prostate Adenocarcinoma, run by NYU Langone Health at 1 site in United States.
Trial summary
The purpose of the study is to evaluate the safety and feasibility of daily-adaptive post-prostatectomy stereotactic body radiotherapy (SBRT) to the prostate fossa in men undergoing salvage radiotherapy after radical prostatectomy. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Adenocarcinoma
- What is being tested?
- Adaptive stereotactic body radiotherapy (SBRT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to Nov 2030
- Phase
- Interventional
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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients at or over 18 years old.
- Have a histologically confirmed diagnosis of prostate adenocarcinoma status post radical prostatectomy who are candidates for salvage postoperative radiotherapy. This includes patients whose Prostate-Specific Antigen (PSA) does not fall to undetectable levels after prostatectomy or that have undetectable PSA after prostatectomy with a subsequent detectable PSA that increases on > 2 determinations or increases to PSA > 0.1 ng/ml. It also includes patients with adverse pathologic features at the time of prostatectomy (e.g. positive surgical margin, pathologic T-stage 3-4 disease, pathologic Gleason score 8-10 disease, presence of tertiary Gleason grade 5 disease) or an intermediate- or high-risk Decipher genomic classifier score.
- No evidence of metastatic disease
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Can complete EPIC-26/IPSS assessments and provide informed consent
Who cannot join
- Distant metastatic disease
- Neuroendocrine or small cell histology
- Prior pelvic radiotherapy which in the opinion of the treating radiation oncologist precludes safe radiation therapy.
- Has a diagnosis of inflammatory bowel disease, active scleroderma, lupus, or other rheumatologic disease which in the opinion of the treating radiation oncologist precludes safe radiation therapy.
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase Ib Single-Arm Study Evaluating Toxicity, Outcomes, and Dosimetry Using Adaptive Stereotactic Body Radiotherapy for the Salvage Treatment of Post-prostatectomy Prostate Cancer
The purpose of the study is to evaluate the safety and feasibility of daily-adaptive post-prostatectomy stereotactic body radiotherapy (SBRT) to the prostate fossa in men undergoing salvage radiotherapy after radical prostatectomy.
Read the detailed description
Patients will have a computed tomography (CT) or Magnetic resonance imaging (MRI) simulation visit as part of the standard of care (SOC), which will be used for treatment planning. Approximately two weeks after the simulation visit, patients will receive adaptive stereotactic body radiation (SBRT) to the prostate fossa at 35 Gy in 5 fractions on the Unity (MR-linac) or Ethos (CT-linac) as SOC. The radiation treatment used in this study is SOC, however, the doses used are investigational and well supported with evidence from clinical trials.
- Conditions
- Prostate Adenocarcinoma
- Being tested
- Adaptive stereotactic body radiotherapy (SBRT)
- Keywords
- prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adaptive stereotactic body radiotherapy (SBRT)Radiation
35 Gy / 5 fx to prostate fossa every other day
- 25 Gy nodes ± 40 Gy boost
- short-course Androgen Deprivation therapy (ADT)
| Study group | Role | What they receive |
|---|---|---|
| Adaptive SBRT | Experimental | Patients will receive stereotactic postoperative radiotherapy to the prostate bed to 35 Gy in 5 fractions over approximately 2 weeks, with elective pelvic nodal irradiation to 25 Gy in 5 fractions for patients with higher-risk features as defined per protocol, and boosting of gross prostatic bed or nodal disease to 40 Gy in 5 fractions if possible. Receives: Radiation: Adaptive stereotactic body radiotherapy (SBRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment completion rate
Measured: Day 15
Incidence of grade ≥3 treatment-related GU/GI toxicity
As per Common Terminology Criteria for Adverse Events (CTCAE) version 6.0 respectively.
Measured: Month 1
Secondary outcomes (7)
Time till onset of physician reported acute and late grade ≥2 and grade ≥3 GU/GI toxicity rates (CTCAE)
Measured: From Day 0 (start of treatment) until Day 15 (end of treatment)
Change in Expanded Prostate Cancer Index Composite-26 (EPIC-26)
The EPIC-26 is a 26-item patient-reported outcome questionnaire developed to evaluate health-related quality of life and side-effect burden in men treated for localized prostate cancer. Scores range from 0-100. Higher scores indicate better functioning and lower symptom bother (fewer side effects), while lower scores reflect severe functional impairment or high symptom burden.
Measured: Baseline, Month 24
Change in International Prostate Symptom Score (IPSS)
The International Prostate Symptom Score (I-PSS) total score ranges from 0 to 35.0 to 7: Mild symptoms, 8 to 19: Moderate symptoms, 20 to 35: Severe symptoms
Measured: Baseline, Month 24
Biochemical recurrence free survival
Measured: Month 12
Biochemical recurrence free survival
Measured: Month 24
Distant metastasis free survival
Measured: Month 12
Distant metastasis free survival
Measured: Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionNov 2028 (estimated)
- Study completionNov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicholas Colangelo, MD, PhD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07888283
- Sponsor's protocol ID
- 26-01011
- Status last verified
- Oct 2026
- First submitted
- 15 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Nicholas.Colangelo@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.