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Chemotherapy

High-Dose Testosterone + Chemotherapy for Prostate Cancer

Phase 2
Recruiting
Led By Michael Schweizer
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must be willing to undergo metastatic biopsy
Age >= 18 years
Must not have
Use of corticosteroids at a dose equivalent to > 10 mg of prednisone daily
Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, history of prior myocardial infarction, uncontrolled major seizure disorder, uncontrolled hypertension (blood pressure [BP] >= 165/100), history of prior stroke, unstable spinal cord compression, superior vena cava syndrome, extensive interstitial bilateral lung disease or any psychiatric disorder that prohibits obtaining informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time from the start of treatment until psa progression (as defined by pcwg3 criteria), assessed up to 3 years
Awards & highlights
No Placebo-Only Group

Summary

This trial tests if high levels of a hormone combined with cancer treatment can help treat prostate cancer that has spread and is not responding to usual treatments. The hormone may damage cancer cell DNA, and the treatment helps kill or slow the cancer cells.

Who is the study for?
Men over 18 with advanced prostate cancer resistant to hormone therapy and no prior chemo for this condition. They must have rising PSA levels, adequate organ function, ECOG status of 2 or less, life expectancy of at least 16 weeks, and agree to use two forms of contraception. Cannot join if they've had major surgery recently, uncontrolled medical issues, other cancers (with exceptions), known allergies to trial drugs or certain infections.
What is being tested?
The SPECTRA study is testing whether high doses of testosterone combined with chemotherapy drugs Carboplatin or Etoposide can help treat metastatic castration-resistant prostate cancer by damaging the DNA in tumor cells that thrive in low testosterone environments.
What are the potential side effects?
Potential side effects include reactions related to high testosterone levels such as mood swings and increased risk of cardiovascular events. Chemotherapy may cause nausea, fatigue, hair loss, blood disorders like anemia or clotting problems and increase infection risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am willing to have a biopsy of my metastatic cancer.
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I am 18 years old or older.
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My prostate cancer is growing despite low testosterone levels.
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My prostate cancer has worsened after treatment with abiraterone or enzalutamide.
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My kidney function, measured by creatinine clearance, is adequate.
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I have at least one cancer lesion that can be monitored with scans.
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My prostate cancer has been confirmed through a biopsy.
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I can take care of myself but might not be able to do heavy physical work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am taking more than 10 mg of prednisone or its equivalent daily.
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I do not have any serious uncontrolled health conditions.
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I do not have severe heart failure or a heart attack in the last 5 years.
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I have lasting side effects from cancer treatment, but not hair loss.
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My prostate cancer causes me pain.
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I had major surgery more than 2 weeks ago and have recovered.
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I plan to undergo another cancer treatment besides LHRH analogues.
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I am allergic to testosterone cypionate, etoposide, carboplatin, or their ingredients.
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I do not have active hepatitis B or C.
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I had a blood clot or lung clot in the last 5 years and am not on blood thinners.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time from the start of treatment until psa progression (as defined by pcwg3 criteria), assessed up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and time from the start of treatment until psa progression (as defined by pcwg3 criteria), assessed up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Greater than or equal to 50% decline in prostate-specific antigen from baseline (PSA50) response rate
Secondary study objectives
Functional Assessment of Cancer Therapy - Prostate (FACT-P)
Incidence of adverse events
International Index of Erectile Function (IIEF)
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

6Treatment groups
Experimental Treatment
Active Control
Group I: Cohort Ic (testosterone cypionate, carboplatin)Experimental Treatment8 Interventions
Patients continue to receive ADT per standard of care and receive testosterone cypionate IM and carboplatin IV on day 1 of cycle 1. Patients then receive testosterone cypionate IM and carboplatin IV on day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. All patients undergo a biopsy, blood sample collection, bone scan and CT scan throughout the study.
Group II: Cohort IIc (testosterone cypionate, etoposide)Experimental Treatment8 Interventions
Patients continue to receive ADT per standard of care and receive testosterone cypionate IM on day 1 and etoposide PO QD on days 1-14 of cycle 1. Patients then receive testosterone cypionate IM on day 1 and etoposide PO QD on days 1-14 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. All patients undergo a biopsy, blood sample collection, bone scan and CT scan throughout the study.
Group III: Cohort IIa (testosterone cypionate, etoposide)Active Control8 Interventions
Patients continue to receive ADT per standard of care and receive testosterone cypionate IM on day 1 of cycle 1. Patients then receive testosterone cypionate IM on day 1 and etoposide PO QD on days 1-14 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. All patients undergo a biopsy, blood sample collection, bone scan and CT scan throughout the study.
Group IV: Cohort IIb (testosterone cypionate, etoposide)Active Control8 Interventions
Patients continue to receive ADT per standard of care and receive etoposide PO QD on days 1-14 of cycle 1. Patients then receive testosterone cypionate IM on day 1 and etoposide PO QD on days 1-14 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. All patients undergo a biopsy, blood sample collection, bone scan and CT scan throughout the study.
Group V: Cohort Ia (testosterone cypionate, carboplatin)Active Control8 Interventions
Patients continue to receive ADT per standard of care and receive testosterone cypionate IM on day 1 of cycle 1. Patients then receive testosterone cypionate IM and carboplatin IV on day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. All patients undergo a biopsy, blood sample collection, bone scan and CT scan throughout the study.
Group VI: Cohort Ib (testosterone cypionate, carboplatin)Active Control8 Interventions
Patients continue to receive ADT per standard of care and receive carboplatin IV on day 1 of cycle 1. Patients then receive testosterone cypionate IM and carboplatin IV on day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. All patients undergo a biopsy, blood sample collection, bone scan and CT scan throughout the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Testosterone Cypionate
2011
Completed Phase 2
~150
Biospecimen Collection
2004
Completed Phase 3
~2020
Bone Scan
2015
Completed Phase 2
~50
Biopsy
2014
Completed Phase 4
~1090
Computed Tomography
2017
Completed Phase 2
~2740
Carboplatin
2014
Completed Phase 3
~6120
Etoposide
2010
Completed Phase 3
~2960

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for prostate cancer include androgen deprivation therapy (ADT), which lowers androgen levels to inhibit cancer cell growth, and chemotherapy, which damages the DNA of rapidly dividing cells to induce cell death. An investigational approach, supraphysiological testosterone therapy, involves administering high levels of testosterone to cause DNA damage in tumor cells adapted to low testosterone conditions, potentially resensitizing them to further androgen-directed therapies. Understanding these mechanisms is crucial for personalizing treatment plans and improving patient outcomes, especially in cases where resistance to standard therapies develops.
Does testosterone mediate the relationship between vitamin D and prostate cancer? A systematic review and meta-analysis protocol.Male breast cancer is not congruent with the female disease.

Find a Location

Who is running the clinical trial?

University of WashingtonLead Sponsor
1,812 Previous Clinical Trials
1,913,755 Total Patients Enrolled
18 Trials studying Prostate Cancer
8,094 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,906 Previous Clinical Trials
41,016,753 Total Patients Enrolled
516 Trials studying Prostate Cancer
337,414 Patients Enrolled for Prostate Cancer
Michael SchweizerPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium
10 Previous Clinical Trials
98 Total Patients Enrolled
~31 spots leftby Mar 2027
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