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
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
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
Clareo Health | 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
