What side effects are associated with this type of intervention?

Common treatments for prostate cancer, such as androgen deprivation therapy (ADT) and bipolar androgen therapy (BAT), can cause side effects including decreased libido, fatigue, emotional changes, and cardiovascular risks. Chemotherapy agents like carboplatin and etoposide, which are used in combination with supraphysiological testosterone to induce DNA damage in tumor cells, can lead to nausea, fatigue, and increased risk of infection due to bone marrow suppression.

What prior FDA approvals exist?

The FDA has approved several treatments for prostate cancer that involve androgen manipulation. These include androgen deprivation therapies (ADT) such as leuprolide and goserelin, which reduce testosterone production, and antiandrogens like enzalutamide and abiraterone, which block androgen receptors or inhibit androgen synthesis. These treatments aim to lower testosterone levels or block its effects, thereby slowing the growth of prostate cancer cells. The approach of using supraphysiological testosterone to induce DNA damage in tumor cells adapted to low testosterone conditions is a novel strategy that builds on the concept of manipulating androgen levels to treat prostate cancer.

What other types of research exist?

Promising novel alternatives to supraphysiological testosterone for prostate cancer patients include: 1) Lutetium-177-PSMA-617, a radioligand therapy targeting PSMA-positive metastatic castration-resistant prostate cancer, which has shown efficacy in clinical trials. 2) Enzalutamide combined with androgen deprivation therapy (ADT), which has demonstrated improved survival and quality of life in metastatic hormone-sensitive prostate cancer. 3) Abiraterone acetate plus prednisone, which has been effective in combination with ADT for advanced prostate cancer. 4) Genomic classifiers guiding treatment to dose-escalated image-guided radiation therapy without hormone therapy, which may offer personalized treatment options.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ time from the start of treatment until psa progression (as defined by pcwg3 criteria), assessed up to 3 years

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

Biospecimen Collection

2004

Completed Phase 3

~2030

Testosterone Cypionate

2011

Completed Phase 2

~150

Bone Scan

2015

Completed Phase 2

~50

Biopsy

2014

Completed Phase 4

~1150

Computed Tomography

2017

Completed Phase 2

~2790

Carboplatin

2014

Completed Phase 3

~6120

Etoposide

2010

Completed Phase 3

~2960

0 / 18Eligibility criteria met

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.

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