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

Who can join: the full rules

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

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.