Actively Recruiting
Supraphysiological Androgen to Enhance Treatment Activity in Metastatic Castration-Resistant Prostate Cancer, SPECTRA Study
Led by University of Washington · Updated on 2026-01-14
69
Participants Needed
1
Research Sites
188 weeks
Total Duration
On this page
Sponsors
U
University of Washington
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Supraphysiological Androgen to Enhance Treatment Activity in Metastatic Castration-Resistant Prostate Cancer, SPECTRA Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must be willing to provide informed consent prior to any study specific procedures
- Age >= 18 years
- Documented histologically confirmed adenocarcinoma of the prostate
- Evidence of castration resistant prostate cancer with rising PSA and low testosterone levels
- PSA at least 2 ng/ml and rising on two successive measurements at least two weeks apart
- Progression after at least one next-generation androgen receptor-signalling inhibitor
- At least a 2-week washout period after stopping recent approved therapy for mCRPC
- Subjects in Cohort 3 must show PSMA expression on 68Ga-PSMA-11 PET
- No prior chemotherapy for mCRPC; prior docetaxel for hormone-sensitive prostate cancer allowed
- At least a 2-week washout after any investigational cancer agent
- Hemoglobin >= 9 g/dL with no transfusion in past 28 days
- Absolute neutrophil count >= 1.5 x 10^9/L
- Platelet count >= 100 x 10^9/L
- Total bilirubin <= 1.5 x institutional upper limit of normal
- AST/ALT <= 2.5 x institutional upper limit of normal (or <= 5x ULN if liver metastases present)
- Creatinine clearance >= 51 mL/min
- ECOG performance status <= 2
- Life expectancy >= 16 weeks
- Willing and able to comply with protocol including treatments and visits
- At least one lesion suitable for repeated assessment
- Willing to undergo metastatic biopsy
- Use of two highly effective forms of contraception for sexually active males with partners of childbearing potential during and 6 months after treatment
You will not qualify if you...
- Involvement in planning or conduct of the study
- Other malignancies unless cured with no disease for >= 2 years except some skin and bladder cancers
- Persistent toxicities greater than grade 2 from previous cancer therapy (excluding hair loss)
- Symptomatic uncontrolled brain metastases or untreated spinal cord compression
- Use of corticosteroids above prednisone 10 mg daily
- Concurrent systemic cancer therapy aside from LHRH analogues
- Use of warfarin; other anticoagulants allowed with discussion
- Major surgery within 2 weeks before starting treatment
- Poor medical risk due to serious uncontrolled medical or psychiatric conditions
- Known hypersensitivity to testosterone cypionate, etoposide, carboplatin, or excipients
- Active hepatitis B or C infection
- Serious or unstable medical, psychiatric, or laboratory conditions affecting safety or consent
- Conditions interfering with study compliance or follow-up
- Disease posing risk from testosterone therapy such as certain bone or lymph node metastases
- Prostate cancer-related pain
- Tumor causing urinary obstruction requiring catheterization due to cancer
- History of deep vein thrombosis or pulmonary embolism within 5 years without ongoing anticoagulation
- NYHA class III or IV heart failure or myocardial infarction within 5 years
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Actively Recruiting
Research Team
M
Michael Schweizer
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
9
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