Schedule De-Escalation of 177Lu-PSMA-617 for the Treatment of Metastatic Castrate Resistant Prostate Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorMayo Clinic
About this trial
This phase II trial studies how to improve the usage of Lu 177 vipivotide tetraxetan (177Lu-prostate-specific membrane antigen \[PSMA\]-617) for treating patients with castration-resistant prostate cancer that has spread from where it first started (primary site), to other places in the body (metastatic) utilizing a treatment pause after 5 cycles of therapy versus standard continuous treatment for 6 cycles. Lutetium is a radioligand therapy (RLT). RLT uses a small molecule (in this case 177Lu-PSMA-617) that carries a radioactive component to destroy tumor cells. When lutetium is injected into the body, it attaches to the PSMA receptor found on tumor cells. After lutetium attaches to the PSMA receptor, its radiation component destroys the tumor cell. Giving 177Lu-PSMA-617 for 5 cycles versus 6 cycles may better treat patients with metastatic castrate resistant prostate cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
REGISTRATION INCLUSION CRITERIA
Scheduled at Mayo Clinic Rochester for therapy with 177Lu PSMA-617
PSMA positive metastatic castration resistant prostate cancer (68Ga and 18F PSMA PET will be considered equivalent for eligibility) , defined by molecular imaging prostate specific membrane antigen (miPSMA) score >= 2 on Mayo PET report, including interpretation of outside PET or consensus review of PET by nuclear therapy tumor board note in the patient chart
Willingness to provide mandatory blood draws for correlative research. (This requirement is waived for patients enrolling after receiving cycle 1 of 177Lu PSMA-617,and achieving a near complete response on post therapy SPECT, as these patients will not be able to provide a pre-treatment baseline blood sample.)
Disqualifiers
REGISTRATION EXCLUSION CRITERIA
Another active malignancy requiring therapy such as radiation, chemotherapy, or immunotherapy
Receiving any other investigational agent which would be considered as a treatment for the prostate cancer
Failure to recover from acute, reversible effects of prior therapy regardless of interval since last treatment
Trial design
Design model
Parallel
Treatments tested in this trial
Biospecimen Collection
Procedure/SurgeryUndergo blood sample collection
Bone Scan
Procedure/SurgeryUndergo bone scan
Clinical Observation
Other interventionUndergo active monitoring
Computed Tomography
Procedure/SurgeryUndergo SPECT/CT or PET/CT
Gallium Ga 68 Gozetotide
Other interventionGiven IV
Lutetium Lu 177 Vipivotide Tetraxetan
DrugGiven IV
Positron Emission Tomography
Procedure/SurgeryUndergo PET/CT
Questionnaire Administration
Other interventionAncillary studies
Single Photon Emission Computed Tomography
Procedure/SurgeryUndergo SPECT/CT
Treatment groups
236 Participants
are divided into 3 treatment groupsGroup A: Arm I (177Lu-PSMA-617 standard)Active comparator 8 interventions
Group B: Arm II (177Lu-PSMA-617 treatment pause)Experimental treatment 9 interventions
Group C: Arm III (Treatment pause 177Lu-PSMA-617)Experimental treatment 9 interventions
Trial outcomes
Primary outcomes
1
Progression-free survival
Progression free survival is defined as the time interval between randomization date and the date of disease progression or death, whichever occurs first. Progression will be defined in keeping with Prostate Cancer Clinical Trials Working Group 3 (PCWG3) guidelines. The median progression free survival of each arm, corresponding 95% confidence intervals, and hazard ratio comparing the treatment arm to the control arm will be reported.
Time frame
Up to 5 yearsSecondary outcomes
1
Time to subsequent treatment (TTST)
TTST is defined as the time from randomization to subsequent treatment. Median TTST will be estimated using the Kaplan-Meier method. Patients who do not progress to a subsequent treatment while on study will be censored at the last known follow-up date. The median TTST and corresponding 95% confidence interval will be reported by randomized arm. The log-rank test will be used to compare the two arms on the distribution of TTST.
Time frame
Up to 5 years2
Time to progression (TTP)
TTP is defined as the time from randomization to disease progression. Median TTP will be estimated using the Kaplan-Meier method. Patients who do not experience disease progression while on study will be censored at the last disease assessment date. Deaths will be censored. The median TTP and corresponding 95% confidence interval will be reported by randomized arm. The log-rank test will be used to compare the two arms on the distribution of TTP.
Time frame
Up to 5 years3
Overall survival (OS)
Overall survival is defined as the time from study entry to death from any cause. Vital status and death dates will be obtained be electronic medical record review where possible, and by phone call where unavailable. Median OS will be estimated using the Kaplan-Meier method. Patients who do not experience death while on study will be censored at the last known date alive. The median OS and corresponding 95% confidence interval will be reported by randomized arm. The log-rank test will be used to compare the two arms on the distribution of OS.
Time frame
Up to 5 years4
Incidence of adverse events
Adverse events will be summarized by frequency and severity using Common Terminology Criteria for Adverse Events (CTCAE) v 5.0. The proportion of patients who experience a grade 3+ adverse event at least possibly related to treatment will be reported by arm.
Time frame
Up to 5 yearsSponsors and contacts
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Source ClinicalTrials.gov