Trials / Recruiting
RecruitingNCT06039371
Supraphysiological Androgen to Enhance Treatment Activity in Metastatic Castration-Resistant Prostate Cancer, SPECTRA Study
SPECTRA: Supraphysiological Androgen to Enhance Treatment Activity
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 69 (estimated)
- Sponsor
- University of Washington · Academic / Other
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
OUTLINE: Patients are assigned based on personal preference to 1 of 3 cohorts. COHORT I: Patients are then assigned to 1 of 3 sub-cohorts within cohort I. COHORT Ia: Patients continue to receive ADT and receive testosterone cypionate intramuscularly (IM) on day 1 of cycle 1. Patients then receive testosterone cypionate IM and carboplatin intravenously (IV) on day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. COHORT Ib: Patients continue to receive ADT 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. COHORT Ic: Patients continue to receive ADT 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. COHORT II: Patients are then assigned to 1 of 3 sub-cohorts within cohort II. COHORT IIa: Patients continue to receive ADT and receive testosterone cypionate IM on day 1 of cycle 1. Patients then receive testosterone cypionate IM on day 1 and etoposide orally (PO) once daily (QD) on days 1-14 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. COHORT IIb: Patients continue to receive ADT 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. COHORT IIc: Patients continue to receive ADT 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. COHORT III: Patients are assigned to 1 of 3 sub-cohorts within cohort III. COHORT IIIa: Patients continue to receive ADT and receive testosterone cypionate intramuscularly (IM) on day 1 of cycles 1-6. Patients receive LuPSMA IV on day 1 of cycles 2-6. Cycles repeat every 6 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive testosterone cypionate intramuscularly (IM) on day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo 68Ga-PSMA positron emission tomography (PET) at screening and single photon emission computed tomography (SPECT)/CT throughout the study. COHORT IIIb: Patients continue to receive ADT and LuPSMA IV on day 1 of cycles 1-6. Patients also receive receive testosterone cypionate IM on day 1 of cycles 2-6 . Cycles repeat every 6 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients receive testosterone cypionate IM on day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo 68Ga-PSMA PET at screening and single SPECT/CT throughout the study. COHORT IIIc: Patients continue to receive ADT and receive testosterone cypionate IM on day 1 and LuPSMA IV on day 1 of cycles 1-6. Cycles repeat every 6 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive testosterone cypionate IM on day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo 68Ga-PSMA PET at screening and single SPECT/CT throughout the study. All patients undergo a biopsy on study and blood sample collection on study, and bone scans, dual x-ray absorptiometry (DEXA) and computed tomography (CT) scans throughout the trial. Patients may also undergo an optional second biopsy at the end of study treatment. After completion of study treatment, patients are followed up at 30 days, and then every 6 months for 2 years.
Conditions
- Castration-Resistant Prostate Carcinoma
- Metastatic Prostate Adenocarcinoma
- Stage IVB Prostate Cancer AJCC v8
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Biopsy Procedure | Undergo a biopsy |
| 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 |
| OTHER | Radioconjugate | Given LuPSMA IV |
| 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 |
Timeline
- Start date
- 2024-05-21
- Primary completion
- 2027-03-31
- Completion
- 2027-12-31
- First posted
- 2023-09-15
- Last updated
- 2026-01-14
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06039371. Inclusion in this directory is not an endorsement.