Escalating Cycle 1 Dose of Lu-177-PSMA-617 for the Treatment of Metastatic Castration Resistant Prostate Cancer

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan Rogel Cancer Center
Study ID
NCT07682649
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Metastatic Castration-Resistant Prostate Carcinoma
  • Stage IVB Prostate Cancer AJCC v8

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo collection of urine samples
  • Computed Tomography — PROCEDURE
    Undergo SPECT/CT
  • Gallium Ga 68 Gozetotide — OTHER
    Given Ga-68 PSMA-11
  • Lutetium Lu 177 Vipivotide Tetraxetan — DRUG
    Given IV
  • Positron Emission Tomography — DEVICE
    Undergo PET
  • Questionnaire Administration — OTHER
    Ancillary studies
  • Single Photon Emission Computed Tomography — DEVICE
    Undergo SPECT/CT
  • Technetium Tc-99m Sulfur Colloid — OTHER
    Given IV

Study Details

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.

Key Dates

Start date
Aug 1, 2026
Status verified
Jun 2026
Primary completion
Aug 31, 2027
Completion
Aug 31, 2031

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation (Lu-177-PSMA-617)
    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.

Primary Outcome Measure

Dose limiting toxicity (DLT) [ Time Frame: up to 6 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Michigan Rogel Cancer CenterAnn ArborMichigan48109
Cancer AnswerLine
[email protected]
800-865-1125
Kirk A. Frey, MD (PRINCIPAL_INVESTIGATOR)
Yuni Dewaraja, PhD (SUB_INVESTIGATOR)

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By research site
University of Michigan Rogel Cancer Center· Ann Arbor, MI

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