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177^Lu-PSMA-617 in Combination With Sipuleucel-T for the Treatment of Metastatic Castration-Resistant Prostate Cancer

ConditionsMetastatic Castration-Resistant Prostate AdenocarcinomaStage IVB Prostate Cancer AJCC v8
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18+
SponsorCity of Hope Medical Center

About this trial

This phase I trial compares the effect of lutetium Lu 177 (177\^Lu)-prostate-specific membrane antigen (PSMA)-617 in combination with Sipuleucel-T to 177\^Lu-PSMA-617 alone in treating patients with prostate that has spread from where it first started (primary site) to other places in the body (metastatic) and has continued to grow and spread despite surgical or medical intervention to block androgen production (castration-resistant). 177\^Lu-PSMA-617, a type of radioconjugate, binds to a protein called PSMA, which is found on some prostate tumor cells. It gives off radiation that may kill the tumor cells. Sipuleucel-T, a type of vaccine and a type of cellular adoptive immunotherapy, is made from immune system cells. The cells are treated with a protein that is made by combining a protein found on prostate tumor cells with a growth factor. When the cells are injected back into the patient, they may stimulate T cells to kill prostate tumor cells. Giving 177\^Lu-PSMA-617 in combination with sipuleucel-T may be safe, tolerable, and/or effective compared to 177\^Lu-PSMA-617 alone in treating patients with metastatic castration-resistant prostate cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Documented informed consent of the participant and/or legally authorized representative

Assent, when appropriate, will be obtained per institutional guidelines

Agreement to allow the use of archival tissue from diagnostic tumor biopsies

If unavailable, exceptions may be granted with study principal investigator (PI) approval

Disqualifiers

Any approved or investigational anticancer therapy, including chemotherapy, hormonal therapy (e.g., androgen receptor [AR] antagonists, 5 alpha reductase inhibitor, estrogen), or radiotherapy, within 4 weeks prior to initiation of study treatment

External beam radiation therapy or surgery

Chrysanthemum morifolium/Ganoderma lucidum/Glycyrrhiza glabra/Isatis indigotica/Panax pseudoginseng/Rabdosia rubescens/Scutellaria baicalensis/Serona repens supplement (PC-SPES) (or PC-SPEC) or saw palmetto

Systemic corticosteroids. Use of inhaled, intranasal, and topical steroids is acceptable

Trial design

Design model

Parallel

Treatments tested in this trial

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

  • Bone Scan

    Procedure/Surgery

    Undergo bone scan

  • Computed Tomography

    Procedure/Surgery

    Undergo CT and PSMA PET/CT

  • Leukapheresis

    Procedure/Surgery

    Undergo leukapheresis

  • Lutetium Lu 177 Vipivotide Tetraxetan

    Drug

    Given IV

  • Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo MRI

  • PSMA PET Scan

    Procedure/Surgery

    Undergo PSMA PET/CT

  • Sipuleucel-T

    Biological/Vaccine

    Given IV

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Arm A (177^Lu-PSMA-617)Active comparator 7 interventions
Group B: Arm B (177^Lu-PSMA-617, sipuleucel-T)Experimental treatment 8 interventions

Trial outcomes

Primary outcomes

1

Anti-prostatic acid phosphatase (PAP) immunoglobulin G (IgG) antibody response rate

Will be defined as the proportion of patients with an IgG titer \> 400. Comparisons between study arms will be performed using the Fisher's exact test. Descriptive statistics will be used to summarize the antibody response rates, and Clopper-Pearson exact 95% confidence intervals will be calculated.

Time frame
Between week 7 and week 19
2

Change in anti-PAP IgG antibody titers

Descriptive statistics will be used to summarize antibody titer levels at each time point. Comparisons between study arms will be performed using the Wilcoxon signed-rank test or Student's t-test, as appropriate.

Time frame
Between week 7 and week 19

Secondary outcomes

1

Change in anti-PA2024 antibody titers

Descriptive statistics will be used to summarize antibody titer levels at each time point. Comparisons between study arms will be performed using the Wilcoxon signed-rank test or Student's t-test, as appropriate.

Time frame
Between week 7 and week 19
2

Incidence of adverse events

Comparison of toxicities will be assessed using Common Terminology Criteria for Adverse Events version (v) 5.0 criteria.

Time frame
Up to 30 days after last dose of study treatment
3

Proportion of patients achieving a ≥ 50% reduction in prostate specific antigen (PSA) levels (PSA50 response rate)

The PSA50 response rate will be calculated for each treatment arm as the proportion of patients achieving PSA50 response among all evaluable patients. A Fisher's exact test will be used to compare response rates between arms.

Time frame
At baseline up to 3 years
4

Objective response rate

The association between treatment arm and overall response as per RECIST v 1.1 criteria (response observed versus not observed) will be examined using Fisher's exact test.

Time frame
Up to 3 years

Other outcomes

Sponsors and contacts

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

City of Hope Medical Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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