A Phase 2 interventional study of Androgen Deprivation Therapy (ADT) and Androgen Receptor Pathway Inhibitors (ARPIs) in Metastatic Hormone-Sensitive Prostate Cancer (mHSPC), sponsored by University of Nebraska. Not yet recruiting at 1 site in United States. Open to male participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by University of Nebraska · Phase 2, Interventional, and Treatment
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:
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's planned enrollment of 56 is close to the median of 60 across 5,348 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →University of Nebraska is the lead sponsor of 496 studies on the registry; 67 are open to participants now.
Of its 83 completed or terminated interventional studies of FDA-regulated products, 53 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Continuous ARPI + intermittent ADT based on supra-castrate testosterone
Drug: Androgen Deprivation Therapy (ADT) · Drug: Androgen Receptor Pathway Inhibitors (ARPIs)
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.
Continued continuously.
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.
Time frame: Enrollment to the end of follow up at 18 months.
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.
Time frame: Enrollment to the end of follow up at 18 months.
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
Time frame: Enrollment to the end of follow up at 18 months.
Overall survival
Overall survival: time from treatment initiation to death
Time frame: Enrollment to the end of follow up at 18 months.
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.
Time frame: Day 1, Months 6, 12, and 18
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".
Time frame: Day 1, Months 6, 12, and 18
Number of GnRH agonist doses able to be skipped in the 18-month period
Doses of GnRH skipped
Time frame: Enrollment to the end of follow up at 18 months.
Number of participants able to skip >2 doses of GnRH agonist before testosterone becomes supra-castrate
Doses of GnRH skipped
Time frame: Enrollment to the end of follow up at 18 months.
Tumor growth via PSA kinetics
PSA level ng/mL
Time frame: Day 1, Months 3, 6, 9, 12, 15, and 18.
Time to non-castrate testosterone according to specific ADT and ARPI regimens
Testosterone level ng/dL
Time frame: Day 1, Months 3, 6, 9, 12, 15, and 18.
Correlation of duration of ADT plus ARPI therapy with time to non-castrate testosterone
Testosterone level ng/dL
Time frame: Day 1, Months 3, 6, 9, 12, 15, and 18.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for Jan 2030, 37 months later.
Of 610 non-industry phase 2 interventional studies under Prostatic Neoplasms, half reached primary completion within 57 months of starting (the median), counting those still running; a quarter within 39 and three quarters within 86. This study's planned 37 months is below that.
Counting every sponsor, half of 724 studies reached it within 53 months; a quarter within 34 and three quarters within 80.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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