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
Qualifiers
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
Treatments tested in this trial
- Biospecimen Collection
- Bone Scan
- Clinical Observation
- Computed Tomography
- Gallium Ga 68 Gozetotide
- Lutetium Lu 177 Vipivotide Tetraxetan
- Positron Emission Tomography
- Questionnaire Administration
- Single Photon Emission Computed Tomography
Treatment groups
236 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov