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

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.

Conditions

• Castration-Resistant Prostate Carcinoma
• Metastatic Prostate Adenocarcinoma
• Stage IVB Prostate Cancer AJCC v8

Interventions

PROCEDURE

Dual X-ray Absorptiometry

Undergo DEXA

OTHER

Gallium Ga 68-PSMA-617

Given gallium 68Ga-PSMA-617

PROCEDURE

Positron Emission Tomography

Undergo 68Ga-PSMA PET

PROCEDURE

Single Photon Emission Computed Tomography

Undergo SPECT/CT

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Bone Scan

Undergo bone scan

DRUG

Carboplatin

Given IV

PROCEDURE

Computed Tomography

Undergo CT

DRUG

Etoposide

Given PO

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Questionnaire Administration

Ancillary studies

DRUG

Testosterone Cypionate

Given IM

PROCEDURE

Biopsy Procedure

Undergo a biopsy

OTHER

Radioconjugate

Given LuPSMA IV

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• University of Washington

  lead OTHER

Principal Investigators

• Michael Schweizer · Fred Hutch/University of Washington Cancer Consortium

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-05-21

Primary Completion

2027-03-31

Completion

2027-12-31

FDA Drug

Yes

Countries

• United States

Study Locations