Trial · NCT06499870
Relugolix and Enzalutamide in Combination With Radiation Therapy for the Treatment of Very High Risk Prostate Cancer, OPTIMAL Trial
NCT06499870, Phase 2, Recruiting, Sean Sachdev
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Relugolix and Enzalutamide in Combination With Radiation Therapy for the Treatment of Very High Risk Prostate Cancer, OPTIMAL Trial. Trials, record NCT06499870. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06499870
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Relugolix and Enzalutamide in Combination With Radiation Therapy for the Treatment of Very High Risk Prostate Cancer, OPTIMAL Trial
- NCT number
- NCT06499870
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 50 participants, estimated
- Lead sponsor
- Sean Sachdev
- Conditions
- Prostate Adenocarcinoma
- Interventions
Biopsy, Biospecimen Collection, Computed Tomography, Enzalutamide, Fluorine F 18 Piflufolastat, Image Guided Radiation Therapy, Magnetic Resonance Imaging, Positron Emission Tomography, Questionnaire Administration, Relugolix
- First posted
- 2024-07-15
- Last updated
- 2026-10-30
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pathologic response (biopsy positivity rate) | At 2 years | Will determine the efficacy of radiation therapy with relugolix and enzalutamide, for a total duration of 18 months, in patients with National Comprehensive Cancer Network very high-risk prostate cancer, by a 2-year biopsy positivity rate. |
| Secondary | Disease-free survival | Up to 4 years | Will be determined by biochemical failure of prostate specific antigen nadir + 2ng/mL, local or regional recurrence, distant metastasis, or death. Median survival time will be estimated with corresponding 95% confidence intervals. |
| Secondary | Testosterone recovery | Up to 4 years | Testosterone recovery will be defined as a total serum testosterone of ≥ 200 ng/dL. |
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.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA060553 | The Robert H. Lurie Comprehensive Cancer Center | PLATANIAS, LEONIDAS C. | NORTHWESTERN UNIVERSITY | NATIONAL CANCER INSTITUTE | 1993 to 2025 |
Source NIH RePORTER
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/NCT06499870
GET https://conductscience.org/api/trials/v1/NCT06499870/registered