Cabazitaxel +/- Carboplatin vs 177Lu-PSMA-617 in Metastatic Castrate-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
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
Treatments tested in this trial
- Cabazitaxel and carboplatin
- Lu-PSMA-617
Treatment groups
44 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov