Supraphysiological Androgen to Enhance Treatment Activity in Metastatic Castration-Resistant Prostate Cancer, SPECTRA Study
Eligible age
18+ yrs
Accepts
Men
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: University of Washington
You may qualify if…
- ✓ 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-signalling inhibitor (e.g., abiraterone, enzalutamide, etc.). There must be at least a 2-week washout period after stopping the most recent approved therapy for metastatic castration-resistant prostate cancer (mCRPC) (e.g., abiraterone, enzalutamide, Ra-223, sipuleucel-t) prior to cycle 1, day 1. If applicable, patients should be weaned off steroids at least 1 week prior to starting treatment
- ✓ Subjects enrolling to Cohort 3 must demonstrate evidence of PSMA expression on 68Ga-PSMA-11 PET as defined in the VISION trial
- ✓ No prior chemotherapy for the treatment of mCRPC. Patients may have received docetaxel for the treatment of hormone-sensitive prostate cancer
You may not qualify if…
- ✕ Involvement in the planning and/or conduct of the study
- ✕ Other malignancy unless curatively treated with no evidence of disease for \>= 2 years except: adequately treated non-melanoma skin cancer, non-muscle invasive bladder cancer
- ✕ Persistent toxicities (Common Terminology Criteria for Adverse Event (CTCAE) grade \> 2) caused by previous cancer therapy, excluding alopecia
- ✕ Patients with symptomatic uncontrolled brain metastases. A scan to confirm the absence of brain metastases is not required. Patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days
- ✕ Use of corticosteroids at a dose equivalent to \> 10 mg of prednisone daily
- ✕ Planning to receive concurrent treatment with another systemic cancer therapy, aside from a luteinizing hormone releasing hormone (LHRH) analogue
- ✕ Use of warfarin is not permitted. Low-molecular weight heparin and direct oral anticoagulants are allowed, but their use should be discussed with the principal investigator (PI) first
- ✕ Major surgery within 2 weeks of starting study treatment and patients must have recovered from any effects of any major surgery
Where it's recruiting
Seattle
Source: ClinicalTrials.gov · NCT06039371 · last updated 2026-07-21