Trial · NCT06463457
Comeback From Long coursE Androgen Deprivation Therapy (ADT) With RElugolix and Darolutamide (CLEARED)
NCT06463457, Phase 2, Active not recruiting, Atish Choudhury, MD
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Comeback From Long coursE Androgen Deprivation Therapy (ADT) With RElugolix and Darolutamide (CLEARED). Trials, record NCT06463457. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06463457
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comeback From Long coursE Androgen Deprivation Therapy (ADT) With RElugolix and Darolutamide (CLEARED)
- NCT number
- NCT06463457
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 33 participants, estimated
- Lead sponsor
- Atish Choudhury, MD
- Conditions
- Prostate Cancer, Advanced Prostate Cancer, Hormone Sensitive Prostate Cancer
- Interventions
- Darolutamide, Relugolix
- First posted
- 2024-06-17
- Last updated
- 2026-03-09
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 18-month Rate of Testosterone Recovery | 42 months (18 months after completion of 2 years of treatment) | Rate of testosterone recovery (TR) defined as the proportion of participants achieving testosterone ≥ lower limit of normal by 18 months after completion of study treatment. Participants who withdrew from trial therapy (due to early progression, toxicity, patient/physician decision or death) before completing 2 years of treatment will be excluded from the analysis. Participants who require resumption of androgen deprivation, withdraw, are lost to follow-up, or die before 18 months of post-treatment follow up has been completed without having achieved testosterone recovery ≥ lower limit of normal beforehand will be included in the analysis and will be considered to be non-recovered. |
| Primary | Grade 3-5 Treatment-related Toxicity Rate | 24 months. AE collected on day 1 of each cycle (up to 26 cycles in total, each cycle is 28 days) | All grade 3-5 adverse events (AE) with treatment attribution of possibly, probably or definitely related to study treatment based on Common Terminology Criteria for Adverse Events (CTCAE) version 5 are counted. Rate is the proportion of treated participants experiencing at least one of these adverse events as defined during the time of observation. |
| Secondary | Geometric Mean Ratio of Single-dose Cmax (highest concentration of drug) and Steady-state Ctrough (the concentration of drug in the blood immediately before the next dose is administered) | 29 days. Pharmacokinetic (PK) collection prior to the first dose of both drugs and then after 2 hours, 4 hours and 8 hours (Cohort 1) or after 24 hours, 7 days, and 28 days (Cohort 2) of uninterrupted dosing during cycle 1 (each cycle is 28 days). | Geometric mean ratio (GMR) of single-dose Cmax (Cohort 1) and steady-state Ctrough (Cohort 2) of darolutamide and relugolix calculated as the geometric mean when administered in combination with the other agent divided by geometric mean when administered as monotherapy (historical control). |
| Secondary | Rate of Treatment Discontinuation | 24 months. Treatment planned on day 1 of each cycle (up to 26 cycles in total, each cycle is 28 days) | Rate of treatment discontinuation defined as the proportion of participants who discontinued treatment due to 1) adverse events, 2) disease progression, and 3) participant withdrawal. |
| Secondary | Mean Functional Assessment of Cancer Therapy - Prostate (FACT-P) Score | 42 months. Collected at Cycle 1 day 1 (each cycle is 28 days), end of treatment (24 months), and end of study at 18 months after completion of treatment (42 months) | The FACT-P is a well-established, 39-item questionnaire that was developed and validated specifically in participants with advanced prostate cancer. The FACT-P total score ranges from 0 to 156. Higher values of the FACT-P total and all subscales indicate a higher quality of life. |
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/NCT06463457
GET https://conductscience.org/api/trials/v1/NCT06463457/registered