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177Lu-PSMA-617 With Liver Directed Therapy in Metastatic Castration Resistant Prostate Cancer

ConditionsMetastatic Prostate CancerProstate Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18+
SponsorUniversity of California, San Francisco

About this trial

This is an open label, single arm, phase 1b study to determine the safety of combining sequential Prostate-Specific Membrane Antigen (PSMA)-targeted 177Lu-PSMA-617 radionuclide therapy with liver-directed therapy in metastatic castrate-resistant prostate cancer (mCRPC) patients with liver metastases amenable to liver-directed therapy who have progressed on at least one prior androgen pathway inhibitor.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically confirmed prostate cancer.

Progressive disease by PCWG3 criteria at study entry.

Male participants who are at least 18 years of age on the day of signing informed consent.

Castrate level of serum testosterone at study entry (< 50 ng/dL). Note: Participants without prior bilateral orchiectomy are required to remain on Luteinizing hormone-releasing hormone (LHRH) analogue treatment for duration of study treatment.

Disqualifiers

De novo small cell neuroendocrine prostate cancer.

One or more extrahepatic soft tissue lesions (lymph nodes > 1.5 cm in short axis, visceral/soft tissue lesions > 1 cm) on screening CT that is negative on PSMA PET. Non- PSMA avid liver lesions are allowed.

Recipient of other systemic anti-cancer therapies administered within 14 days, or 5 half lives, whichever is shorter, prior to initiation of study treatment. Note: LHRH analogues are the exception and are permitted

Recipient of prior PSMA-directed radioligand treatment.

Trial design

Design model

Single group

Treatments tested in this trial

  • 177Lu-PSMA-617

    Drug

    Given intravenously (IV)

  • Ablation

    Procedure/Surgery

    Undergo ablation

  • Trans-arterial chemoembolization (TACE)

    Procedure/Surgery

    Undergo TACE

  • Positron Emission Tomography (PET)/Computerized tomography (CT)

    Procedure/Surgery

    Undergo imaging

  • Tumor Biopsy

    Procedure/Surgery

    Undergo biopsy

  • Questionnaire

    Other intervention

    Participant will complete questionnaire

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Treatment (177Lu-PSMA-617)Experimental treatment 6 interventions

Trial outcomes

Primary outcomes

1

Percentage of participants with treatment emergent adverse events.

Treatment emergent adverse events will be classified according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Adverse events and clinically significant laboratory abnormalities (meeting Grade 3, 4, or 5 criteria according to CTCAE) will be summarized by maximum intensity and relationship to Lu-PSMA-617 and liver-directed therapy (if applicable). Descriptive statistics will be utilized to display the data on toxicity seen. Descriptive summaries of discrete data will present the number of study participants and the incidence as a frequency and a percentage.

Time frame
up to 12 months
2

Objective response Rate (ORR)

ORR is defined as the proportion of treated participants who obtained an radiographic objective response \[confirmed complete response (CR) or confirmed partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. Proportion and 95% confidence interval will be reported.

Time frame
up to 12 months

Secondary outcomes

1

Median radiographic Progression-free survival (rPFS)

rPFS is defined as the time that elapses between the initiation of trial therapy Cycle 1 Day 1(C1D1) and the date of radiographic disease progression per Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria for all evaluable patients. If disease progression or death from any cause is not observed prior to initiating subsequent anti-cancer therapy or completing study participation, the rPFS will be censored as the last available disease assessment. Patients who discontinue treatment for clinical progression or deterioration will be included in the analysis. Calculated based on Kaplan-Meier estimates of rPFS.

Time frame
up to 12 months
2

Median Overall Survival (OS)

OS is defined as the overall survival time as the time that elapses between the initiation of trial therapy C1D1 and the date of death from any cause for all evaluable patients. Calculated based on Kaplan-Meier estimates of OS.

Time frame
up to 5 years
3

Median duration of objective response (mDOR)

mDOR is defined as the time that elapses between the day of first documented response to trial therapy (confirmed CR or confirmed PR, whichever is first recorded) and subsequent disease progression (per RECIST v1.1 criteria). Results will be calculated based on Kaplan-Meier product limit method.

Time frame
up to 12 months
4

Hepatic disease response rate (HDRR)

HDRR is defined as the proportion of treated patients who experience an objective hepatic response \[confirmed complete response (CR) or confirmed partial response (PR) per RECIST v1.1criteria.

Time frame
up to 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, San Francisco

Lead sponsor

Novartis

Collaborator

Source ClinicalTrials.gov
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