NCT07882862Not yet recruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 20 Oct 2026
Brief summary (registry, in English)
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 comprised intermediate-risk survivors who underwent short-course ADT (4-17 mo.) and are hypogonadal ≥6 months after ending ADT, and Cohort R is comprised of survivors who recovered to eugonadal levels of testosterone (≥ 300 ng/dL) within 6 months after ending ADT. Participants will be evaluated for clinical findings, toxicities, laboratory abnormalities (CBC, CMP, Lipid panel, Hgb A1C), changes to the hypothalamic-pituitary-gonadal axis (E2, LH, FSH, TT) \[dependent on Cohort\], biochemical recurrence (PSA), and quality of life (FACT-P, FACT-Fatigue, qADAM). Cohort R is an observational natural-recovery control group and will not be treated. Cohort A will be treated with oral clomiphene citrate, 25 mg, once daily for 6 months, then tested for persistence of response (eugonadal testosterone) after a 1-month washout period. After completing study assessments, participants will transition to standard survivorship follow-up. Thereafter, long-term health outcomes will be reviewed to determine the rates of biochemical recurrence and metastasis after 5 years.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 83 (estimated)
- First submitted
- 12 Oct 2026
- Start date
- 31 Jan 2027
- Primary completion date
- 30 Jun 2029
- Lead sponsor
- University of Nebraska
- Diseases
- Prostate cancer
- NCT number
- NCT07882862
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 83
- From 31 Jan 2027 to the primary completion date, 30 Jun 2029
- 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
- Known hypogonadism prior to initiation of ADT
- Prior prostatectomy
- Use of clomiphene citrate, testosterone, or other hormone replacement therapy
- Use of inhibitors or inducers of CYP2D6
Other illness
- Symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia
- Psychiatric illness/social situations or geographical condition that would limit compliance with study requirements
- Recent (within the last 3 months) venous thromboembolism
- Symptoms suggestive of recurrent or metastatic disease
Other
- Known endocrine or liver dysfunction
- Polycythemia
- Known intracranial tumor
- Severe lower urinary tract symptoms
Who the study is looking for
- Histologic diagnosis of adenocarcinoma of the prostate
- No evidence of metastatic disease
- Prior definitive local therapy with radiation
- Prior definitive continuous ADT 4-17 months in duration (treatment may include abiraterone).
- 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.
- PSA \<0.1
- ECOG performance status \< 3
- Prior pre-treatment staging (bone and soft tissue imaging) that ruled out metastatic disease
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 if 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.