Trial · NCT07904026
Testosterone-Informed De-Escalation in Metastatic Prostate Cancer (TIDE PC)
NCT07904026, Phase 2, Not yet recruiting, University of Nebraska
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Testosterone-Informed De-Escalation in Metastatic Prostate Cancer (TIDE PC). Trials, record NCT07904026. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07904026
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Testosterone-Informed De-Escalation in Metastatic Prostate Cancer (TIDE PC)
- NCT number
- NCT07904026
- Status
- Not yet recruiting
- Phases
- Phase 2
- Enrollment
- 56 participants, estimated
- Lead sponsor
- University of Nebraska
- Conditions
- Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
- Interventions
- Androgen Deprivation Therapy (ADT), Androgen Receptor Pathway Inhibitors (ARPIs)
- First posted
- 2026-10-29
- Last updated
- 2026-11-03
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cumulative incidence of participants who experience castration resistance, clinical relapse, or death in the 18-month trial period. | Enrollment to the end of follow up at 18 months. | Castration resistance will be defined as the time interval from treatment initiation to the first documented evidence of castration-resistant prostate cancer according to the Prostate Cancer Clinical Trials Working Group (PCWG2) criteria defined as three consecutive rises in PSA at least 1 week apart, resulting in two 50% increases over the nadir, with a PSA \>2 ng/mL. Clinical relapse will be defined by soft tissue progression according to RECIST criteria, two or more new bone lesions on bone scan, or worsening symptoms attributable to prostate cancer. |
| Secondary | Time to PSA PFS defined as castration resistance, death, or clinical/radiographic progression | Enrollment to the end of follow up at 18 months. | Time to PSA PFS defined as castration resistance, clinical progression, or death. |
| Secondary | Number of participants transitioned to continuous ADT based on 2 consecutive rises in PSA of combined >0.2 at least 3 weeks apart | Enrollment to the end of follow up at 18 months. | Number of participants transitioned to continuous ADT |
| Secondary | Overall survival | Enrollment to the end of follow up at 18 months. | Overall survival: time from treatment initiation to death |
| Secondary | Quality of life based on Hot Flash-Related Daily Interference Scale (HFRDIS) | Day 1, Months 6, 12, and 18 | Scale from 0-10. Zero is equivalent to does not interfere and 10 is equivalent to completely interferes with specific aspects of life. |
| Secondary | Quality of life based on Functional Assessment of Cancer Therapy - Prostate (FACT-P) | Day 1, Months 6, 12, and 18 | The scoring system uses a 5-point Likert scale (from 0 to 4). The total score is calculated by summing the scores across all domains, providing a range of 0 to 156. Zero is equal to "Not at all", 1 is equal to "A little bit", 2 is equal to "Somewhat", 3 is equal to "Quite a bit", and 4 is equal to 'Very much". |
| Secondary | Number of GnRH agonist doses able to be skipped in the 18-month period | Enrollment to the end of follow up at 18 months. | Doses of GnRH skipped |
| Secondary | Number of participants able to skip >2 doses of GnRH agonist before testosterone becomes supra-castrate | Enrollment to the end of follow up at 18 months. | Doses of GnRH skipped |
| Secondary | Tumor growth via PSA kinetics | Day 1, Months 3, 6, 9, 12, 15, and 18. | PSA level ng/mL |
| Secondary | Time to non-castrate testosterone according to specific ADT and ARPI regimens | Day 1, Months 3, 6, 9, 12, 15, and 18. | Testosterone level ng/dL |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
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/NCT07904026
GET https://conductscience.org/api/trials/v1/NCT07904026/registered