RightFit
Not 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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
19 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 6 months

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether clomiphene citrate safely raises testosterone, a hormone, after radiation and hormone-lowering therapy (ADT) for prostate cancer that has not spread. People whose testosterone stays low at least 6 months after ADT take a daily pill for 6 months; those whose levels return to normal within 6 months are watched without treatment. The study also checks side effects, quality of life, and whether the cancer returns.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have prostate adenocarcinoma, a type of prostate cancer, confirmed by a tissue test.
  • Have no signs that cancer has spread to other parts of the body.
  • Had radiation to treat the prostate cancer.
  • Had ADT without breaks for 4–17 months; treatment may have included abiraterone.
  • Have a testosterone blood test: below 300 ng/dL for the treatment group, or 300 ng/dL or higher for the group watched without treatment.
  • Have a PSA blood test result below 0.1. PSA is a protein used to track prostate cancer.
  • Have an ECOG activity score below 3: able to care for yourself and be up for more than half the day.
  • Had bone and other body scans before treatment showing the cancer had not spread.

Who can't join

  • Had low testosterone before ADT, or had surgery to remove the prostate.
  • Have a known hormone-system or liver problem, or too many red blood cells.
  • Have heart failure with symptoms, unstable chest pain, or an abnormal heart rhythm.
  • Have a known tumor inside the skull.
  • Have a mental health condition, social situation, or location that would make study requirements hard to follow.
  • Use clomiphene, testosterone, other hormone replacement, or medicines that block or speed up CYP2D6, which helps the body process medicines.
  • Had a blood clot in a vein within the past 3 months.
  • Have severe problems passing urine, or symptoms suggesting the cancer has returned or spread.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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

Study sites (1)

NE