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Cabazitaxel +/- Carboplatin vs 177Lu-PSMA-617 in Metastatic Castrate-resistant Prostate Cancer

ConditionsMetastatic Prostate CancerMetastatic Castration-resistant Prostate Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age19+
SponsorCase Comprehensive Cancer Center

About this trial

The purpose of this study is to find out what treatment works best for participants with metastatic prostate cancer that are not responding to hormone treatment and docetaxel and are also Prostate-specific membrane antigen(PSMA) positive.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants must have histologically or cytologically confirmed adenocarcinoma of prostate

Evidence of metastatic castrate-resistant prostate cancer that has previously been treated with an androgen receptor pathway inhibitor. Prior docetaxel exposure is recommended but not mandatory. Tissue is not mandatory, but a pathologic report is required at time of enrollment.

Patients must have a PSMA-positive 18F-rhPSMA-7.3 performed within 12 weeks from C1D1 with ≥1 site with SUVmax ≥10. An alternative PSMA PET tracer is permitted at baseline if performed within 8 weeks prior to randomization.

Baseline PSMA SUVmean <10 OR

Disqualifiers

Evidence of hormone-sensitive prostate cancer (HSPC)

Evidence of small cell prostate cancer

Participants receiving any other investigational agents.

Diagnosis of another clinically significant malignancy within the previous 2 years other than curatively treated non-melanomatous skin cancer or superficial urothelial carcinoma and other in situ or noninvasive malignancies, as determined by the PI or Co-PI.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cabazitaxel and carboplatin

    Drug

    Given IV

  • Lu-PSMA-617

    Drug

    Given IV

Treatment groups

44 Participants
are divided into 2 treatment groups
Group A: Arm 1: Cabazitaxel and carboplatinExperimental treatment 1 intervention
Group B: Arm 2: Lu-PSMA-617Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

PSA response rate as assessed by the change in PSA ratio

PSA decline of ≥50% (PSA50) at 12 weeks. PSA decline will be measured by obtaining the ratio of PSA obtained on cycle 5 day 1 to baseline PSA obtained cycle 1 day 1.

Time frame
Baseline, 12 weeks post intervention

Secondary outcomes

1

Progression Free Survival

Time frame
Upto 26 weeks
2

Time to next systemic therapy

Time frame
Cycle 1 day1(each cycle will be 6 weeks upto 10 cycles) to the first day of subsequent systemic cancer-directed therapy

Other outcomes

Sponsors and contacts

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

Case Comprehensive Cancer Center

Lead sponsor

Source ClinicalTrials.gov
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