Active — Not RecruitingPhase 1/2

Phase I Dose-escalation Study of Fractionated 177Lu-PSMA-617 for Progressive Metastatic CRPC

United States50 participantsStarted 2016-12

Plain-language summary

The purpose of this study is to find the highest dose level of the study drug, 177Lu-PSMA-617 that can be given without severe side effects for advanced prostate cancer.

Who can participate

Age range18 Years – 99 Years

SexMALE

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Inclusion criteria

✓. Histologically or cytologically confirmed adenocarcinoma of prostate
✓. Documented progressive metastatic CRPC based on Prostate Cancer Working Group 3 (PCWG3) criteria, which includes at least one of the following criteria:
✓. ECOG performance status of 0-2
✓. Have serum testosterone \< 50 ng/dL. Subjects must continue primary androgen deprivation with an LHRH/GnRH analogue (agonist/antagonist) if they have not undergone orchiectomy.
✓. Have previously been treated with at least one of the following:
✓. Have previously received taxane chemotherapy, been determined to be ineligible for taxane chemotherapy by their physician, or refused taxane chemotherapy.
✓. Age \> 18 years
✓. Patients must have normal organ and marrow function as defined below:

Exclusion criteria

✕. Use of investigational drugs or implantation of investigational medical device ≤4 weeks of Cycle 1, Day 1 or current enrollment in investigational drug or device study
✕. Prior systemic beta-emitting bone-seeking radioisotopes
✕. Brain metastases or leptomeningeal disease
✕. History of deep vein thrombosis and/or pulmonary embolus within 1 month of study entry
✕. Other serious illness(es) involving the cardiac, respiratory, CNS, renal, hepatic or hematological organ systems which might preclude completion of this study or interfere with determination of causality of any adverse effects experienced in this study
✕. Radiation therapy for treatment of PCa ≤4 weeks of Day 1 Cycle 1
✕. Patients on stable dose of bisphosphonates or denosumab, which have been started no less than 4 weeks prior to treatment start, may continue on this medication, however patients are not allowed to initiate bisphosphonate/Denosumab therapy during the DLT-assessment period of the study.
✕. Having partners of childbearing potential and not willing to use a method of birth control deemed acceptable by the principle investigator and chairperson during the study and for 1 month after last study drug administration

What they're measuring

Number of Subjects With Dose Limiting Toxicity (DLT) of Fractionated Dose of 177Lu-PSMA-617

Timeframe: Assessed throughout the DLT period, up to 92 days after starting study drug.

Number of Subjects That Achieved Cumulative Maximum Tolerated Dose (MTD) Phase II Dose of 177Lu-PSMA-617

Timeframe: from first dose of study drug to at least 12 weeks of subsequent follow-up evaluations, up to 92 days

Recommended Phase II Dose of 177Lu-PSMA-617 in a 2-week Dose-fractionation Regimen

Timeframe: Duration of Phase I, up to 47 months

Trial details

NCT IDNCT03042468

SponsorWeill Medical College of Cornell University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-09-30

Results submitted2022-09-30

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