Trial · NCT06397703
ADT and SBRT vs SBRT Alone for Unfavorable Intermediate Risk Prostate Cancer
NCT06397703, Phase 2, Recruiting, NYU Langone Health
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. ADT and SBRT vs SBRT Alone for Unfavorable Intermediate Risk Prostate Cancer. Trials, record NCT06397703. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06397703
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- ADT and SBRT vs SBRT Alone for Unfavorable Intermediate Risk Prostate Cancer
- NCT number
- NCT06397703
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 392 participants, estimated
- Lead sponsor
- NYU Langone Health
- Conditions
- Prostate Cancer
- Interventions
- Leuprolide, Degarelix or Relugolix, Stereotactic body radiation therapy/radiosurgery (SBRT)
- First posted
- 2024-05-03
- Last updated
- 2026-01-28
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Disease-Free Survival | Up to Year 5 | Defined as the percentage of participants who survive without any signs or symptoms of prostate cancer. |
| Secondary | Incidence of Biochemical Failure | Up to Year 5 | Biochemical failure recurrence will be determined according to the established Phoenix criteria of 2 ng/nl elevation of the prostate specific antigen (PSA) nadir level (nadir + 2 definition). |
| Secondary | Incidence of Distant Metastases | Up to Year 5 | Number of distant metastases observed over the course of the study. |
| Secondary | Overall Survival | Up to Year 5 | Defined as the length of time from the date of first treatment until death. |
| Secondary | Number of Positive Post-Treatment Biopsies | Year 2 Post-Treatment (Month 24-30) | |
| Secondary | Change in Expanded Prostate Cancer Index Composite (EPIC) Questionnaire Score (EPIC-26) | Baseline, Year 2 | 26-item assessment of prostate cancer symptoms. Late bowel function as reported by the patient using the standardized questionnaire Expanded Prostate Cancer Index Composite (EPIC) sub-domain approximately 1 year after the end of treatment. The EPIC questionnaire contains 26 questions measuring patient function. Each question has a response option ranging from 0 or 1 (best) to 3, 4, or 5 (worst). The responses then correlate to a scoring scale of 0 to 100, where 0 is the best and 100 is the worst. The values vary from 0 to 100 for each question. The scores are averaged to derive a quality of life score, ranging from 0-100. |
| Secondary | Change in International Prostatism Symptom Score (IPSS) | Baseline, Year 2 | 7-item questionnaire of benign prostatic hyperplasia (BPH) symptoms. Each item is rated on a scale from 0 (not at all) to 5 (almost always). The total score is the sum of responses and ranges from 0 to 35; higher scores indicate greater BPH symptomology. |
| Secondary | Change in 12-Item Short Form Health Survey (SF-12) Score | Baseline, Year 2 | The SF-12 is a 12-item assessment of the impact of health on an individual's everyday life. The total score is the sum of each item and is standardized; the total score ranges from 0 to 100, with higher scores indicated better physical and mental health functioning. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06397703
GET https://conductscience.org/api/trials/v1/NCT06397703/registered