177Lu-PSMA-617 with Sipuleucel-T for Metastatic Castration-Resistant Prostate Cancer
This study is looking at men with prostate cancer that has spread (metastatic) and is still growing despite hormone treatment (castration-resistant). It compares two treatments: 177Lu-PSMA-617 alone versus 177Lu-PSMA-617 combined with Sipuleucel-T. 177Lu-PSMA-617 is a type of radiation treatment that targets prostate cancer cells. Sipuleucel-T is a type of immunotherapy, which uses your body's immune system to fight cancer. The study wants to see if combining these treatments creates a stronger immune response against the cancer. It also aims to check the safety and effectiveness of the combined treatment. About 30 men will participate.
- Study design
- This is an interventional study, meaning participants will receive specific treatments. It is a randomized study, comparing two different treatment approaches.
- What's involved
- You would undergo blood sample collections, bone scans, CT scans, and PSMA PET/CT scans. You would also have a procedure called leukapheresis and receive treatments intravenously (IV) every 6 weeks for up to 6 cycles.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary outcomes, such as antibody responses, will be measured between week 7 and week 19 after starting treatment.
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NCT07219147
177^Lu-PSMA-617 in Combination With Sipuleucel-T for the Treatment of Metastatic Castration-Resistant Prostate Cancer
Recruiting
PHASE1Ages 18+InterventionalTreatmentCity of Hope Medical CenterInvestigator-initiated
~30 participants
Updated 2026-04-20 on ClinicalTrials.gov
What's tested:Biospecimen CollectionBone ScanComputed TomographyLeukapheresisLutetium Lu 177 Vipivotide TetraxetanMagnetic Resonance Imaging
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Anti-prostatic acid phosphatase (PAP) immunoglobulin G (IgG) antibody response rate
Measured over Between week 7 and week 19
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesCalifornia1
Study leadership
- Alex Chehrazi-Raffle, MD · PRINCIPAL_INVESTIGATOR · City of Hope Medical Center
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
Age: ≥ 18 years
Eastern Cooperative Oncology Group (ECOG) ≤ 1
Male
Progressive castration-resistant metastatic prostate cancer with pathologically confirmed adenocarcinoma of the prostate without small cell features
Patients must have either:
Measurable disease
For extranodal (visceral) lesions (e.g. lung, liver, etc.) to be considered measurable, they must be ≥ 10 mm in one dimension, using spiral CT
For lymph nodes to be considered measurable (i.e., target or evaluable lesions), they must be ≥ 20 mm in at least one dimension, using spiral CT
OR non-measurable disease
All other lesions, including small lesions (longest diameter \< 20 mm with conventional techniques or \< 10 mm with spiral CT scan) and truly non-measurable lesions
Lesions that are considered non-measurable include bone lesions (only). Progression on first generation ADT
Patients must have been on androgen deprivation therapy with a gonadotrophin releasing hormone (GnRH) analogue, antagonist, or bilateral orchiectomy (i.e., surgical or medical castration) for at least 3 months prior to study entry and maintain castrate levels of serum testosterone \< 50 ng/dL throughout study participation unless intolerant
Fully recovered from the acute toxic effects (except alopecia) to ≤ grade 1 to prior anti-cancer therapy
Absolute neutrophil count (ANC) ≥ 1,500/mm\^3 (within 10 days prior to day 1 of protocol therapy)
White blood cell (WBC) counts \> 2500/uL (within 10 days prior to day 1 of protocol therapy)
Lymphocyte count ≥ 300/uL (within 10 days prior to day 1 of protocol therapy)
Platelets ≥ 100,000/mm\^3 (within 10 days prior to day 1 of protocol therapy)
Hemoglobin ≥ 9g/dL (within 10 days prior to day 1 of protocol therapy)
NOTE: Red blood cell transfusions are not permitted within 14 days of hemoglobin assessment unless cytopenia is secondary to disease involvement
Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (within 10 days prior to day 1 of protocol therapy) (unless has Gilbert's disease, serum bilirubin level ≤ 3 x ULN)
Aspartate aminotransferase (AST) ≤ 2.5 x ULN (within 10 days prior to day 1 of protocol therapy)
Alanine aminotransferase (ALT) ≤ 3.0 x ULN (within 10 days prior to day 1 of protocol therapy)
Alkaline phosphatase ≤ 3 x ULN (within 10 days prior to day 1 of protocol therapy) (Patients with documented bone metastases, alkaline phosphatase \[ALP\] ≤ 5 x ULN)
Serum creatinine ≤ 1.5 x ULN or creatinine clearance of ≥ 50 mL/min per Cockcroft-Gault formula (within 10 days prior to day 1 of protocol therapy)
If not receiving anticoagulants: International normalized ratio (INR) OR prothrombin (PT) ≤ 1.5 x ULN (within 10 days prior to day 1 of protocol therapy)
If on anticoagulant therapy: PT must be within therapeutic range of intended use of anticoagulants (within 10 days prior to day 1 of protocol therapy)
If not receiving anticoagulants: Activated partial thromboplastin time (aPTT) ≤ 1.3 x ULN (within 10 days prior to day 1 of protocol therapy)
If on anticoagulant therapy: aPTT must be within therapeutic range of intended use of anticoagulants (within 10 days prior to day 1 of protocol therapy)
Seronegative for HIV antigen (Ag)/antibody (Ab) combo, hepatitis C virus (HCV), active hepatitis B virus (HBV) (surface antigen negative), and syphilis (rapid plasma reagin \[RPR\]) (within 10 days prior to day 1 of protocol therapy)
If positive, hepatitis C ribonucleic acid (RNA) quantitation must be performed. OR
If seropositive for HIV, HCV or HBV, nucleic acid quantitation must be performed. Viral load must be undetectable
Meets other institutional and federal requirements for infectious disease titer requirements
Note Infectious disease testing to be performed within 28 days prior to day 1 of protocol therapy
For male patients with partners of childbearing potential, agreement (by patient and/or partner) to use highly effective form(s) of contraception or abstain from heterosexual activity for the course of the study through at least 4 months after the last dose of protocol therapy
Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only)
Exclusion
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
Treatment with any of the following medications or interventions within 28 days of registration:
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
Megestrol acetate (Megace®), diethyl stilbestrol (DES), or cyproterone acetate
Ketoconazole
5-alpha-reductase inhibitors (e.g., finasteride \[Proscar®\], dutasteride \[Avodart®\])
High dose calcitriol (1,25\[OH\]2 vitamin \[Vit\]D) (i.e., \> 7.0 ug/week)
Prior treatment with 177\^Lu-PSMA-617 and/or sipuleucel-T
Radiation therapy for bone metastasis within 2 weeks or any other radiation therapy within 4 weeks before first dose of study treatment
Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis; cirrhosis; fatty liver; and inherited liver disease
Treatment with any investigational vaccine within 2 years of registration or treatment with any other investigational product within 28 days of registration
Patients with acute leukemias, accelerated/blast-phase chronic myelogenous leukemia, chronic lymphocytic leukemia, Burkitt lymphoma, plasma cell leukemia, or non-secretory myeloma
Known primary central nervous system (CNS) malignancy or symptomatic CNS metastases
Inability to comply with study and follow-up procedures
Any other active malignancy at time of first dose of study treatment or diagnosis of another malignancy within 3 years prior to first dose of study treatment that requires active treatment, except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast
Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
What this trial measures
- Anti-prostatic acid phosphatase (PAP) immunoglobulin G (IgG) antibody response rateBetween week 7 and week 19
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.
- Change in anti-PAP IgG antibody titersBetween week 7 and week 19
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.