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

ConditionsCastration-Resistant Prostate CarcinomaMetastatic Prostate AdenocarcinomaStage IVB Prostate Cancer AJCC v8
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorUniversity of Washington

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Must be willing to provide informed consent prior to any study specific procedures

Age >= 18 years

Documented histologically confirmed adenocarcinoma of the prostate

Patient must have evidence of castration resistant prostate cancer as evidenced by PSA progression (per Prostate Cancer Working Group 3 [PCWG3] criteria) and a castrate serum testosterone level (i.e., =< 50 mg/dL)

Disqualifiers

Involvement in the planning and/or conduct of the study

Other malignancy unless curatively treated with no evidence of disease for >= 2 years except: adequately treated non-melanoma skin cancer, non-muscle invasive bladder cancer

Persistent toxicities (Common Terminology Criteria for Adverse Event (CTCAE) grade > 2) caused by previous cancer therapy, excluding alopecia

Patients with symptomatic uncontrolled brain metastases. A scan to confirm the absence of brain metastases is not required. Patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days

Trial design

Design model

Parallel

Treatments tested in this trial

  • Biopsy Procedure

    Procedure/Surgery

    Undergo a biopsy

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

  • Bone Scan

    Procedure/Surgery

    Undergo bone scan

  • Carboplatin

    Drug

    Given IV

  • Computed Tomography

    Procedure/Surgery

    Undergo CT

  • Etoposide

    Drug

    Given PO

  • Quality-of-Life Assessment

    Other intervention

    Ancillary studies

  • Questionnaire Administration

    Other intervention

    Ancillary studies

  • Testosterone Cypionate

    Drug

    Given IM

  • Radioconjugate

    Other intervention

    Given LuPSMA IV

  • Dual X-ray Absorptiometry

    Procedure/Surgery

    Undergo DEXA

  • Gallium Ga 68-PSMA-617

    Other intervention

    Given gallium 68Ga-PSMA-617

  • Positron Emission Tomography

    Procedure/Surgery

    Undergo 68Ga-PSMA PET

  • Single Photon Emission Computed Tomography

    Procedure/Surgery

    Undergo SPECT/CT

Treatment groups

69 Participants
are divided into 9 treatment groups

9

Treatment groups

See each treatment group below.

Group A: Cohort Ia (testosterone cypionate, carboplatin)Active comparator 9 interventions
Group B: Cohort Ib (testosterone cypionate, carboplatin)Active comparator 9 interventions
Group C: Cohort Ic (testosterone cypionate, carboplatin)Experimental treatment 9 interventions
Group D: Cohort IIa (testosterone cypionate, etoposide)Active comparator 9 interventions
Group E: Cohort IIb (testosterone cypionate, etoposide)Active comparator 9 interventions
Group F: Cohort IIc (testosterone cypionate, etoposide)Experimental treatment 9 interventions
Group G: Cohort IIIa (ADT, testosterone cypionate, LuPSMA)Experimental treatment 12 interventions
Group H: Cohort IIIb (ADT, testosterone cypionate, LuPSMA)Experimental treatment 12 interventions
Group I: Cohort IIIc (ADT, testosterone cypionate, LuPSMA)Experimental treatment 12 interventions

Trial outcomes

Primary outcomes

1

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

Will assess \>= 50% decline in PSA following treatment with combination bipolar androgen therapy (BAT) and genotoxic chemotherapy (at least 12 weeks of total therapy). Will be calculated as the percentage with 95% confidence interval (CI) of the total number of subjects that achieved a PSA50 response.

Time frame
From baseline up to 3 years

Secondary outcomes

1

Radiographic response

Will be assessed using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Best radiographic response for each patient will be presented in a waterfall plot.

Time frame
Up to 3 years
2

Radiographic progression-free survival (PFS)

Will be assessed using RECIST 1.1 and Prostate Cancer Working Group 3 (PCWG3) criteria. Will be presented with Kaplan-Meier curves, and the median survival with 95% CI will be calculated. Rates will be reported as percentages with 95% CI.

Time frame
The start of treatment until disease progression (per modified RECIST criteria or PCWG3 criteria for bone lesions), clinical progression (as determined by the treating physician), or death, whichever occurs first, assessed up to 3 years
3

PSA PFS

Will be assessed using PCWG3 criteria. Will be presented with Kaplan-Meier curves, and the median survival with 95% CI will be calculated. Rates will be reported as percentages with 95% CI. Best on study PSA for each patient will be presented in a waterfall plot.

Time frame
Time from the start of treatment until PSA progression (as defined by PCWG3 criteria), assessed up to 3 years
4

Overall survival

Will be presented with Kaplan-Meier curves, and the median survival with 95% CI will be calculated. Rates will be reported as percentages with 95% CI.

Time frame
The start of treatment until death from any cause, assessed up to 3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Washington

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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