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AzTrials

Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)Phase 2NCT07904026

Testosterone-Informed De-Escalation in Metastatic Prostate Cancer (TIDE PC)

A Phase 2 study testing Androgen Deprivation Therapy (ADT) and Androgen Receptor Pathway Inhibitors (ARPIs) in people with Metastatic Hormone-Sensitive Prostate Cancer (mHSPC), run by University of Nebraska at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 19 years and older, men only
What is being tested?
Androgen Deprivation Therapy (ADT) and Androgen Receptor Pathway Inhibitors (ARPIs)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
1 siteUnited States
Study dates
24 Dec 2026to Jan 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

IIT Office contact

402-559-4596

iitoffice@unmc.edu

United States1 site

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

    IIT Office, 402-559-4596, iitoffice@unmc.edu

    Benjamin Teply

Other trials in United States

About this study

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.

Read more

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
Being tested
Androgen Deprivation Therapy (ADT), Androgen Receptor Pathway Inhibitors (ARPIs)
Keywords
Metastatic Prostate Cancer, Testosterone, De-Escalation
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Androgen Deprivation Therapy (ADT)Drug

    At each three-month visit, when the participant's testosterone level is <50ng/dL, the participant's ADT in the form of a GnRH agonist will be held. When it is >50ng/dL, it will be given. Participants will continue to undergo routine follow-up with PSA and testosterone levels every 3 months for the duration of the trial, continuing to give GnRH agonist if testosterone >50ng/dL and holding it if testosterone is <50ng/dL.

  • Androgen Receptor Pathway Inhibitors (ARPIs)Drug

    Continued continuously.

Study groups in NCT07904026
Study groupRoleWhat they receive
Continuous ARPI + Intermittent ADT based on supra-castrate testosteroneExperimentalContinuous ARPI + intermittent ADT based on supra-castrate testosterone
Receives: Drug: Androgen Deprivation Therapy (ADT); Drug: Androgen Receptor Pathway Inhibitors (ARPIs)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cumulative incidence of participants who experience castration resistance, clinical relapse, or death in the 18-month trial period.

    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.

    Measured: Enrollment to the end of follow up at 18 months.

Secondary outcomes (10)

  1. Time to PSA PFS defined as castration resistance, death, or clinical/radiographic progression

    Time to PSA PFS defined as castration resistance, clinical progression, or death.

    Measured: Enrollment to the end of follow up at 18 months.

  2. Number of participants transitioned to continuous ADT based on 2 consecutive rises in PSA of combined >0.2 at least 3 weeks apart

    Number of participants transitioned to continuous ADT

    Measured: Enrollment to the end of follow up at 18 months.

  3. Overall survival

    Overall survival: time from treatment initiation to death

    Measured: Enrollment to the end of follow up at 18 months.

  4. Quality of life based on Hot Flash-Related Daily Interference Scale (HFRDIS)

    Scale from 0-10. Zero is equivalent to does not interfere and 10 is equivalent to completely interferes with specific aspects of life.

    Measured: Day 1, Months 6, 12, and 18

  5. Quality of life based on Functional Assessment of Cancer Therapy - Prostate (FACT-P)

    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".

    Measured: Day 1, Months 6, 12, and 18

  6. Number of GnRH agonist doses able to be skipped in the 18-month period

    Doses of GnRH skipped

    Measured: Enrollment to the end of follow up at 18 months.

  7. Number of participants able to skip >2 doses of GnRH agonist before testosterone becomes supra-castrate

    Doses of GnRH skipped

    Measured: Enrollment to the end of follow up at 18 months.

  8. Tumor growth via PSA kinetics

    PSA level ng/mL

    Measured: Day 1, Months 3, 6, 9, 12, 15, and 18.

  9. Time to non-castrate testosterone according to specific ADT and ARPI regimens

    Testosterone level ng/dL

    Measured: Day 1, Months 3, 6, 9, 12, 15, and 18.

  10. Correlation of duration of ADT plus ARPI therapy with time to non-castrate testosterone

    Testosterone level ng/dL

    Measured: Day 1, Months 3, 6, 9, 12, 15, and 18.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2026
  2. Study start24 Dec 2026 (estimated)
  3. Primary completionJan 2030 (estimated)
  4. Study completionJan 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
56 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07904026
Sponsor's protocol ID
TIDE PC
Status last verified
Oct 2026
First submitted
12 Oct 2026
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Androgen Deprivation Therapy (ADT) and Androgen Receptor Pathway Inhibitors (ARPIs) in people with Metastatic Hormone-Sensitive Prostate Cancer (mHSPC), run by University of Nebraska at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact IIT Office (402-559-4596, iitoffice@unmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cumulative incidence of participants who experience castration resistance, clinical relapse, or death in the 18-month trial period. (time frame: Enrollment to the end of follow up at 18 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07904026.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

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