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NCT06039371 · ClinicalTrials.gov registry record · Phase 2
Supraphysiological Androgen to Enhance Treatment Activity in Metastatic Castration-Resistant Prostate Cancer, SPECTRA Study
A Phase 2 study of Stage IVB Prostate Cancer AJCC v8 and Castration-Resistant Prostate Carcinoma, sponsored by University of Washington.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 69
- Enrollment target
- 1
- Study location
NCT06039371 is a Phase 2 study of Stage IVB Prostate Cancer AJCC v8 and Castration-Resistant Prostate Carcinoma that is actively recruiting participants, run by University of Washington. The registered enrollment target is 69 participants, below the 176-participant average among 45 other Stage IVB Prostate Cancer AJCC v8 trials with a reported enrollment target (61% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06039371, a Phase 2 study of Stage IVB Prostate Cancer AJCC v8 and Castration-Resistant Prostate Carcinoma, is actively recruiting participants, sponsored by University of Washington.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 69 participants
- Enrollment target
- 1
- Study location
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 Studied
Interventions
- DRUG Carboplatin
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Biopsy Procedure
- PROCEDURE Bone Scan
Study Locations (1)
Washington
- Fred Hutch/University of Washington Cancer Consortium - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 69 participants |
| Start Date | 2024-05-21 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06039371
The ClinicalTrials.gov registry entry for NCT06039371 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 69 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 176-participant average among 45 other Stage IVB Prostate Cancer AJCC v8 trials with a reported enrollment target (61% lower). The listed sponsor is University of Washington, which has 1,048 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Stage IVB Prostate Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Carboplatin is the first listed.
NCT06039371 reports 1 study location spanning 1 distinct geographic area - top geographies include Washington.
Frequently Asked Questions
What is clinical trial NCT06039371 about?
NCT06039371 is a clinical study titled "Supraphysiological Androgen to Enhance Treatment Activity in Metastatic Castration-Resistant Prostate Cancer, SPECTRA Study". 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 despi...
What is the current status of trial NCT06039371?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 69 participants. The study started on 2024-05-21. Estimated completion is 2027-12-31.
What conditions does trial NCT06039371 study?
This clinical trial studies the following conditions: Stage IVB Prostate Cancer AJCC v8, Castration-Resistant Prostate Carcinoma, Metastatic Prostate Adenocarcinoma.
What interventions are being tested in trial NCT06039371?
The interventions under investigation include: Carboplatin (DRUG), Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Biopsy Procedure (PROCEDURE), Bone Scan (PROCEDURE).
Who is sponsoring clinical trial NCT06039371?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06039371 being conducted?
This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Castration-Resistant Prostate Carcinoma
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Washington
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