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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

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

Study Summary

This trial studies if giving higher-than-normal testosterone with chemotherapy may help treat advanced prostate cancer.

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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Greater than or equal to 50% decline in prostate-specific antigen from baseline (PSA50) response rate

Secondary outcome measures

Functional Assessment of Cancer Therapy - Prostate (FACT-P)

Incidence of adverse events

International Index of Erectile Function (IIEF)

+4 more

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 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.

Group IV: 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 V: 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 VI: 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 2

~1700

Biopsy

2014

Completed Phase 4

~1090

Computed Tomography

2017

Completed Phase 2

~2720

Testosterone Cypionate

2011

Completed Phase 1

~110

Carboplatin

2014

Completed Phase 3

~6670

Etoposide

2010

Completed Phase 3

~2440

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of WashingtonLead Sponsor

1,741 Previous Clinical Trials

1,847,714 Total Patients Enrolled

18 Trials studying Prostate Cancer

8,244 Patients Enrolled for Prostate Cancer

National Cancer Institute (NCI)NIH

13,672 Previous Clinical Trials

40,926,395 Total Patients Enrolled

561 Trials studying Prostate Cancer

507,095 Patients Enrolled for Prostate Cancer

Michael SchweizerPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium

10 Previous Clinical Trials

98 Total Patients Enrolled

1 Trials studying Prostate Cancer

20 Patients Enrolled for Prostate Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it still possible to enroll in this trial for participants?

"Unfortunately, according to data found on clinicaltrials.gov, this particular study is no longer actively recruiting patients. Originally posted in January 2024 and last amended September 2023, the trial has been discontinued; however there are 1275 other trials currently looking for participants."

Answered by AI

Has the combination of testosterone cypionate and carboplatin (Cohort Ic) been granted regulatory approval?

"There is preliminary evidence indicating the safety of Cohort Ic (testosterone cypionate, carboplatin), so it was assigned a score of 2. As this is Phase 2 research, there are no clinical trials demonstrating its efficacy as yet."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Supraphysiological Androgen to Enhance Chemotherapy Treatment Activity in Metastatic Castration-Resistant Prostate Cancer, SPECTRA Study

2024. "Supraphysiological Androgen to Enhance Chemotherapy Treatment Activity in Metastatic Castration-Resistant Prostate Cancer, SPECTRA Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06039371.

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