A Phase 1 interventional study of Biospecimen Collection and Computed Tomography in Metastatic Castration-Resistant Prostate Carcinoma and Stage IVB Prostate Cancer AJCC v8, sponsored by University of Michigan Rogel Cancer Center. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-06.
Sponsored by University of Michigan Rogel Cancer Center · Phase 1, Interventional, and Treatment
This phase I trial studies the safety, side effects, and treatment cycle 1 best dose of Lu-177-PSMA-617 in patients with prostate cancer that keeps growing even when the amount of testosterone in the body is reduced to very low levels (castration-resistant) and has spread from where it first started (primary site) to other places in the body (metastatic). Lu-177-PSMA-617 is a radioactive drug. It binds to a protein called prostate-specific membrane antigen (PSMA), which is found on prostate cancer tumor cells. Lu-177-PSMA-617 gives off radiation that may kill these tumor cells. It is a type of radioconjugate. Lu-177-PSMA-617 is currently used in a series of 6 intravenous infusions of the standard dosage, each separated by 6 weeks from the previous infusion. Investigators have observed that the first therapy administration (cycle 1) delivers better radiation treatment to the cancer than each of the following 5 infusions. Giving an increased dosage of Lu-177-PSMA-617 in treatment cycle 1 may have a better effect on metastatic castration-resistant prostate cancer than the standard dosage. The study does not change the total cumulative activity from what is used in the standard dosage treatment but gives an increased dosage in cycle 1 and reduces the total number of cycles.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,399 are open to participants now.
This study's planned enrollment of 20 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →University of Michigan Rogel Cancer Center is the lead sponsor of 317 studies on the registry; 47 are open to participants now.
Of its 46 completed or terminated interventional studies of FDA-regulated products, 30 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients receive Lu-177-PSMA-617 IV on day 1 of each cycle. Dose escalation will occur in cycle 1 only: Level 1: 14.8 GBq (7.4 GBq administered 2 times, 2 days apart) Level 2: 22.2 GBq (7.4 GBq administered 3 times, each 2 days apart) Cycles repeat every 6 weeks for up to 5 cycles for dose level 1 and up to 4 cycles for dose level 2, with the Lu-177-PSMA-617 dose of 7.4 GBq, in the absence of disease progression or unacceptable toxicity. Patients also undergo SPECT/CT scans and receive Ga-68 PSMA-11 and undergo PET/CT after cycle 1.
Procedure: Biospecimen Collection · Procedure: Computed Tomography · Other: Gallium Ga 68 Gozetotide · Drug: Lutetium Lu 177 Vipivotide Tetraxetan · Device: Positron Emission Tomography · Other: Questionnaire Administration · Device: Single Photon Emission Computed Tomography · Other: Technetium Tc-99m Sulfur Colloid
Undergo collection of urine samples
Also known as: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection
Undergo SPECT/CT
Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, Diagnostic CAT Scan, Diagnostic CAT Scan Service Type, tomography
Given Ga-68 PSMA-11
Also known as: (68)Ga labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC, (68)Ga-labeled Glu-urea-Lys(Ahx)-HBED-CC, (68)Ga-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC, (68)Gallium-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC, (68Ga)Glu-urea-Lys(Ahx)-HBED-CC, 68Ga-DKFZ-PSMA-11, 68Ga-HBED-CC-PSMA, 68Ga-labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC, 68Ga-PSMA, 68Ga-PSMA-11, 68Ga-PSMA-HBED-CC, [68Ga] Prostate-specific Membrane Antigen 11, [68Ga]GaPSMA-11, AAA 517, AAA-517, AAA517, Ga PSMA, Ga-68 labeled DKFZ-PSMA-11, Ga-68 labeled PSMA-11, GA-68 PSMA-11, Gallium Ga 68 PSMA-11, Gallium Ga 68-labeled PSMA-11, GALLIUM GA-68 GOZETOTIDE, Gallium-68 PSMA, Gallium-68 PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC, GaPSMA, PSMA-HBED-CC GA-68
Given IV
Also known as: 177Lu-labeled PSMA-617, 177Lu-PSMA-617, AAA 617, AAA-617, AAA617, Lu177-PSMA-617, Lutetium Lu 177-PSMA-617, LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN, Lutetium-177-PSMA-617, Pluvicto
Undergo PET
Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, PT
Ancillary studies
Undergo SPECT/CT
Also known as: Medical Imaging, Single Photon Emission Computed Tomography, Single Photon Emission Tomography, Single-Photon Emission Computed, single-photon emission computed tomography, SPECT, SPECT imaging, SPECT SCAN, SPET, ST, tomography, emission computed, single photon, Tomography, Emission-Computed, Single-Photon
Given IV
Also known as: Tc 99m Sulfur Colloid, Tc-99m SC, Technetium Tc 99m Sulfur Colloid
Dose limiting toxicity (DLT)
The rate of drug-related adverse events that meet protocol-specified dose-limiting criteria and occur during the time period from administration of cycle 1 dosage up to administration of cycle 2 dosage.
Time frame: up to 6 weeks
Incidence of treatment related adverse events
Any treatment related adverse events of Grade 3 or higher (according to CTCAE v5.0) from time of cycle 1 administration until time of cycle 2 administration and from time of cycle 1 administration until 12 weeks after the last cycle administration
Time frame: at 6 weeks after first dose and 12 weeks after last dose
Completion of overall multi-cycle (4-5 cycles) planned treatment course
To determine the rate of successful completion of the complete planned treatment course (total of 4 or 5 cycles)
Time frame: Up to 30 weeks
Biochemical (prostate-specific antigen [PSA]) response
Will be estimated as the proportion of patients with ≥ 50% drop in serum PSA levels from baseline to 6 weeks after first cycle and from baseline to 12 weeks after last cycle
Time frame: at 6 weeks after first dose and 12 weeks after last dose
PSMA PET/CT response
Will be estimated as the proportion of patients with ≥ 30% drop in PSMA positive tumor volume on PET/CT from baseline to 6 weeks after first cycle and from baseline to 12 weeks after last cycle
Time frame: at 6 weeks after first dose and 12 weeks after last dose
Plan to share: No
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University of Michigan Rogel Cancer Center