Early access
Sign in
Not yet taking people in United StatesPhase 2

Pausing Hormone Therapy in Metastatic Hormone-Sensitive Prostate Cancer Based on Testosterone Levels

Tests pausing androgen deprivation therapy in men with metastatic hormone-sensitive prostate cancer.

Key facts

Who runs it
University of Nebraska
Where
Omaha, United StatesSee the site
Trial code
Registry title
Testosterone-Informed De-Escalation in Metastatic Prostate Cancer (TIDE PC)
Status
Not yet recruiting
Phase
Phase 2
People taking part
56 people, planned
Starts
24 Dec 2026
Expected to end
Jan 2030
Type of study
Interventional
Treatments tested
  • Androgen Deprivation Therapy (ADT)
  • Androgen Receptor Pathway Inhibitors (ARPIs)
Record updated
3 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for men with metastatic hormone-sensitive prostate cancer whose PSA has stayed low on long-term hormone therapy plus an ARPI drug. It tests pausing the hormone therapy (ADT) when testosterone is low.

Age
19 years or older
Sex
Men only
Disease stage
Metastatic hormone-sensitive prostate cancer, with a stable PSA below 4.0 ng/mL at enrollment
Earlier treatment
Must have had continuous ADT with a GnRH agonist (Leuprolide, Goserelin, or Triptorelin) plus an ARPI (Abiraterone acetate with prednisone, Enzalutamide, Apalutamide, or Darolutamide) for 18 months or more
Biomarker or test result
Testosterone below 50 ng/dL

Main reasons for not taking part

  • ECOG score above 2
  • Surgical castration
  • A second cancer likely to affect life expectancy
  • More than 1 missed appointment (no show) in the last year

The registry criteria, word for word

Show all 10 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Surgical castration
  • Second malignancy likely to affect life expectancy
  • ECOG>2
  • Greater than 1 appointment no show in the last year

Where in United States

  • University of Nebraska Medical CenterOmaha, United StatesContact: IIT OfficeNot yet recruiting

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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

The group in the trial

  • Continuous ARPI + Intermittent ADT based on supra-castrate testosteroneTreatment being tested

    Treatment: Androgen Deprivation Therapy (ADT) and Androgen Receptor Pathway Inhibitors (ARPIs)

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Testosterone-Informed De-Escalation in Metastatic Prostate Cancer (TIDE PC)
Plain-language title
Pausing Hormone Therapy in Metastatic Hormone-Sensitive Prostate Cancer Based on Testosterone LevelsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 13 November 2026.
Record updated
3 November 2026