HRT-PC Trial: Hormone Recovery After Treatment for Prostate Cancer Trial. An Open-label Phase II Study of Clomiphene Citrate in Patients With Persistent Hypogonadism After ADT for Treatment of Localized Prostate Cancer
Run by University of Nebraska · NCT07882862 · Data updated 2026-11-12
Not yet open. This study is not taking new participants. Its registered completion date is 2029-06-30.
The purpose of this phase II trial is to assess the clinical utility of clomiphene citrate for the augmentation of testosterone in prostate cancer survivors who complete androgen deprivation therapy (ADT), including the efficacy and tolerability of clomiphene, patient-reported quality of life outcomes, metabolic effects, biomarkers of response, and the oncologic safety of increasing testosterone. Up to 83 eligible participants who have completed radiation and ADT for non-metastatic prostate cancer will participate in this study. Participants are assigned to one of two cohorts: Cohort A is com…
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 19 Years and up |
| Sex | Men only |
| Enrollment | 83 (estimated) |
| Sponsor | University of Nebraska Academic / other |
| Drugs / interventions | Clomiphene Citrate 25mg |
| Locations | 1 site (United States) |
| Trial ID | NCT07882862 on ClinicalTrials.gov |
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Histologic diagnosis of adenocarcinoma of the prostate 2. No evidence of metastatic disease 3. Prior definitive local therapy with radiation 4. Prior definitive continuous ADT 4-17 months in duration (treatment may include abiraterone). 5. Available serum testosterone measurement. Testosterone \< 300 ng/dL is required for inclusion in Cohort A; testosterone ≥300 ng/dL is required for inclusion in Cohort R. 6. PSA \<0.1 7. ECOG performance status \< 3 8. Prior pre-treatment staging (bone and soft tissue imaging) that ruled out metastatic disease Exclusion Criteria: 1. Known hypogonadism prior to initiation of ADT 2. Prior prostatectomy 3. Known endocrine or liver dysfunction 4. Polycythemia 5. Symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia 6. Known intracranial tumor 7. Psychiatric illness/social situations or geographical condition that would limit compliance with study requirements 8. Use of clomiphene citrate, testosterone, or other hormone replacement therapy 9. Recent (within the last 3 months) venous thromboembolism 10. Severe lower urinary tract symptoms 11. Use of inhibitors or inducers of CYP2D6 12. Symptoms suggestive of recurrent or metastatic disease
Where it's running
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University if Nebraska Medical Center
Omaha, Nebraska, United States
Study contacts
- Principal investigator: Benjamin Teply, MD — University of Nebraska
- Study coordinator: IIT Office
- Email: iitoffice@unmc.edu
- Phone: 402-559-4596
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.