RecruitingPhase 2NCT06039371

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

SPECTRA: Supraphysiological Androgen to Enhance Treatment Activity


Sponsor

University of Washington

Enrollment

69 participants

Start Date

May 21, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether giving very high doses of testosterone (called bipolar androgen therapy) can help treat prostate cancer that has stopped responding to hormone-lowering treatments, which is known as castration-resistant prostate cancer. **You may be eligible if...** - You are 18 or older with confirmed prostate cancer - Your cancer has continued to grow despite hormone-lowering treatment (castration-resistant), and your testosterone remains very low - Your PSA (a prostate cancer marker in the blood) is at least 2 ng/mL and rising - You have already tried at least one newer hormone-blocking drug (such as abiraterone or enzalutamide) **You may NOT be eligible if...** - You have untreated or growing brain metastases - You have significant liver disease or other serious organ dysfunction - You are currently on certain medications that interact with testosterone treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiopsy Procedure

Undergo a biopsy

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREBone Scan

Undergo bone scan

DRUGCarboplatin

Given IV

PROCEDUREComputed Tomography

Undergo CT

DRUGEtoposide

Given PO

OTHERQuality-of-Life Assessment

Ancillary studies

OTHERQuestionnaire Administration

Ancillary studies

DRUGTestosterone Cypionate

Given IM

OTHERRadioconjugate

Given LuPSMA IV

PROCEDUREDual X-ray Absorptiometry

Undergo DEXA

OTHERGallium Ga 68-PSMA-617

Given gallium 68Ga-PSMA-617

PROCEDUREPositron Emission Tomography

Undergo 68Ga-PSMA PET

PROCEDURESingle Photon Emission Computed Tomography

Undergo SPECT/CT


Locations(1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

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NCT06039371


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