SPECTRA: Supraphysiological Androgen to Enhance Treatment Activity
University of Washington
Summary
This phase II trial studies how well giving testosterone at levels higher than normally found in the body (supraphysiological) works to enhance chemotherapy treatment, and Lutetium 177Lu-prostate specific-membrane antigen (PSMA)-617 (LuPSMA) in patients with prostate cancer that has progressed despite being previously treated with androgen therapies and has spread from where it first started (prostate) to other places in the body (metastatic castration-resistant prostate cancer). In patients that have developed progressive cancer in spite of standard hormonal treatment, administering supraphysiological testosterone may result in regression of tumors by causing deoxyribonucleic acid (DNA) damage in tumor cells that have adapted to low testosterone conditions. Carboplatin is in a class of medications known as platinum-containing compounds. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair and may kill tumor cells. Radioactive drugs, such as LuPSMA, may carry radiation directly to tumor cells and not harm normal cells. Giving supraphysiological levels of testosterone and carboplatin or etoposide or LuPSMA together may be an effective treatment for metastatic castration-resistant prostate cancer.
Description
OUTLINE: Patients are assigned based on personal preference to 1 of 3 cohorts. COHORT I: Patients are then assigned to 1 of 3 sub-cohorts within cohort I. COHORT Ia: Patients continue to receive ADT and receive testosterone cypionate intramuscularly (IM) on day 1 of cycle 1. Patients then receive testosterone cypionate IM and carboplatin intravenously (IV) on day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. COHORT Ib: Patients continue to receive ADT and receive carboplatin IV on day 1 of cycle 1. Patients then receive…
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: * Must be willing to provide informed consent prior to any study specific procedures * Age \>= 18 years * Documented histologically confirmed adenocarcinoma of the prostate * Patient must have evidence of castration resistant prostate cancer as evidenced by PSA progression (per Prostate Cancer Working Group 3 \[PCWG3\] criteria) and a castrate serum testosterone level (i.e., =\< 50 mg/dL) * PSA must be at least 2 ng/ml and rising on two successive measurements at least two weeks apart * Patients must have progressed on at least one prior next-generation androgen receptor-s…
Interventions
- ProcedureBiopsy Procedure
Undergo a biopsy
- ProcedureBiospecimen Collection
Undergo blood sample collection
- ProcedureBone Scan
Undergo bone scan
- DrugCarboplatin
Given IV
- ProcedureComputed Tomography
Undergo CT
- DrugEtoposide
Given PO
- OtherQuality-of-Life Assessment
Ancillary studies
Location
- Fred Hutch/University of Washington Cancer ConsortiumSeattle, Washington