An interventional study of Adaptive stereotactic body radiotherapy (SBRT) in Prostate Adenocarcinoma, sponsored by NYU Langone Health. Not yet recruiting at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by NYU Langone Health · Not applicable, Interventional, and Treatment
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.
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.
6,484 studies on the registry are indexed under Prostatic Neoplasms; 1,415 are open to participants now.
This study's planned enrollment of 30 is below the median of 58 across 4,908 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →NYU Langone Health is the lead sponsor of 1,421 studies on the registry; 254 are open to participants now.
Of its 231 completed or terminated interventional studies of FDA-regulated products, 195 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
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.
Radiation: Adaptive stereotactic body radiotherapy (SBRT)
35 Gy / 5 fx to prostate fossa every other day * 25 Gy nodes ± 40 Gy boost * short-course Androgen Deprivation therapy (ADT)
Treatment completion rate
Time frame: Day 15
Incidence of grade ≥3 treatment-related GU/GI toxicity
As per Common Terminology Criteria for Adverse Events (CTCAE) version 6.0 respectively.
Time frame: Month 1
Time till onset of physician reported acute and late grade ≥2 and grade ≥3 GU/GI toxicity rates (CTCAE)
Time frame: 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.
Time frame: 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
Time frame: Baseline, Month 24
Biochemical recurrence free survival
Time frame: Month 12
Biochemical recurrence free survival
Time frame: Month 24
Distant metastasis free survival
Time frame: Month 12
Distant metastasis free survival
Time frame: Month 24
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
Access criteria: The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to Nicholas.Colangelo@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Nov 2028, 24 months later.
Of 1,018 non-industry interventional studies with no phase under Prostatic Neoplasms, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 87. This study's planned 24 months is below that.
Counting every sponsor, half of 1,063 studies reached it within 45 months; a quarter within 22 and three quarters within 87.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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