NCT07904026Not yet recruitingPhase 2
Testosterone-Informed De-Escalation in Metastatic Prostate Cancer (TIDE PC)
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
The purpose of this study is to use androgen deprivation therapy (ADT) intermittently in hopes of reducing side effects from ADT and reducing unnecessary dosing of ADT in adult men with a prolonged response to frontline therapy for metastatic hormone-sensitive prostate cancer (mHSPC). The primary aim is to determine the cumulative incidence of participants who experience prostate-specific antigen (PSA) relapse, clinical relapse, or death in the 18-month trial period. The study will investigate the effects of holding (stopping and restarting as needed) ADT in the participants to monitor time to non-castrate testosterone, quality of life, and outcomes when ADT is only restarted when testosterone is above the castration-level threshold. Androgen receptor pathway inhibitor (ARPI) will be continued for additional safety. PSA will be monitored throughout to ensure there is no rise. Additionally, quality of life will be monitored throughout to determine whether greater time between ADT doses leads to improvement in side effects. Participants will: * See their provider every 3 months * Check Testosterone and PSA levels every 3 months * Hold androgen deprivation therapy (ADT) when testosterone remains \<50 ng/dL and resume ADT when testosterone is ≥50 ng/dL * Continue to take androgen receptor pathway inhibitor (ARPI) throughout the trial * Complete Functional Assessment of Cancer Therapy-Prostate (FACT-P) and Hot Flash Related Daily Interference Scale (HFRDIS) surveys * Undergo imaging throughout the study as clinically indicated, which is consistent with the standard of care
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 56 (estimated)
- First submitted
- 12 Oct 2026
- Start date
- 24 Dec 2026
- Primary completion date
- Jan 2030
- Lead sponsor
- University of Nebraska
- Diseases
- Prostate cancer
- NCT number
- NCT07904026
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 56
- From 24 Dec 2026 to the primary completion date, Jan 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Surgical castration
Other illness
- Second malignancy likely to affect life expectancy
Other
- ECOG\>2
- Greater than 1 appointment no show in the last year
Who the study is looking for
- Patients must have a diagnosis of metastatic hormone-sensitive prostate cancer
- Patients must be ≥19 years of age
- Patients must have stable PSA \<4.0 ng/mL at the time of enrollment (PSA stability includes decreasing PSA, non-increasing PSA, or PSA not increasing by an absolute level of ≥0.2ng/mL on 2 consecutive checks)
- Patients must be receiving therapy with continuous ADT with GnRH agonist (Leuprolide, Goserelin, or Triptorelin) plus ARPI (Abiraterone acetate with prednisone, Enzalutamide, Apalutamide, or Darolutamide) for ≥18 months
- ECOG ≤2
- Testosterone \<50ng/dL
Age in the registry: 19 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Nebraska Medical Center Coordinator of this site? Confirm its status | Omaha | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.