Trial · NCT06631521
Neoadjuvant Darolutamide and Relugolix Combination Preceding Radical Prostatectomy for Prostate Cancer
NCT06631521, Phase 1, Active not recruiting, AdventHealth
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Neoadjuvant Darolutamide and Relugolix Combination Preceding Radical Prostatectomy for Prostate Cancer. Trials, record NCT06631521. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06631521
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Neoadjuvant Darolutamide and Relugolix Combination Preceding Radical Prostatectomy for Prostate Cancer
- NCT number
- NCT06631521
- Status
- Active not recruiting
- Phases
- Phase 1
- Enrollment
- 32 participants, actual
- Lead sponsor
- AdventHealth
- Conditions
- Prostate CA, Prostate Cancer (Adenocarcinoma), Prostate Cancer Surgery
- Interventions
- Darolutamide, Relugolix, Radical Prostatectomy
- First posted
- 2024-10-08
- Last updated
- 2026-11-10
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of patients completing therapy without severe adverse events. | From enrollment, up to 8 weeks after radical prostatectomy. | |
| Primary | Number of patients experiencing treatment-related adverse events using CTCAE version 5.0. | From enrollment, up to 8 weeks following radical prostatectomy (RP) | |
| Secondary | Objective Radiographic Response | From enrollment, up to 12 weeks (end of neoadjuvant therapy). | Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes in millimeters (mm). Response refers to the reduction in tumor size according to the Response Evaluation Criteria in Solid Tumors (RECIST version 1.1) criteria (Complete Response, Partial Response, Stable Disease, or Progressive Disease). |
| Secondary | Prostate-specific antigen (PSA) Response | From enrollment, up to 8 weeks after radical prostatectomy. | The unit of measure is nanograms per milliliter (ng/mL). A PSA response is defined as a decline of ≥50% from baseline levels. |
| Secondary | Plasma Concentration of Darolutamide and Relugolix | From enrollment, up to Day 1 of Cycle 3 (Each cycle is 28 days). | This measure involves assessing the plasma concentration of darolutamide and relugolix at specified time points to determine their pharmacokinetic profiles. Units of measure: Concentration in nanograms per milliliter (ng/mL). |
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/NCT06631521
GET https://conductscience.org/api/trials/v1/NCT06631521/registered