OncoMatch/Clinical Trials/NCT07219147
177^Lu-PSMA-617 in Combination With Sipuleucel-T for the Treatment of Metastatic Castration-Resistant Prostate Cancer
Is NCT07219147 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Sipuleucel-T and Lutetium Lu 177 Vipivotide Tetraxetan for metastatic castration-resistant prostate adenocarcinoma.
Treatment: Lutetium Lu 177 Vipivotide Tetraxetan · Sipuleucel-T — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Prostate Cancer
Disease stage
Required: Stage IVB
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: androgen deprivation therapy (GnRH analogue, GnRH antagonist, bilateral orchiectomy)
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
Cannot have received: 177Lu-PSMA-617 (177Lu-PSMA-617)
Prior treatment with 177^Lu-PSMA-617 and/or sipuleucel-T
Cannot have received: sipuleucel-T (sipuleucel-T)
Prior treatment with 177^Lu-PSMA-617 and/or sipuleucel-T
Cannot have received: chemotherapy
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
Cannot have received: hormonal therapy (androgen receptor antagonist, 5 alpha reductase inhibitor, estrogen)
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
Cannot have received: radiation therapy
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
Cannot have received: external beam radiation therapy
External beam radiation therapy or surgery within 28 days of registration
Cannot have received: systemic corticosteroid (systemic corticosteroids)
Exception: Use of inhaled, intranasal, and topical steroids is acceptable
Systemic corticosteroids. Use of inhaled, intranasal, and topical steroids is acceptable
Cannot have received: other (Chrysanthemum morifolium, Ganoderma lucidum, Glycyrrhiza glabra, Isatis indigotica, Panax pseudoginseng, Rabdosia rubescens, Scutellaria baicalensis, Serona repens supplement (PC-SPES or PC-SPEC), saw palmetto, Megestrol acetate (Megace®), diethyl stilbestrol (DES), cyproterone acetate, ketoconazole, finasteride (Proscar®), dutasteride (Avodart®), high dose calcitriol (> 7.0 ug/week))
Treatment with any of the following medications or interventions within 28 days of registration: 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; Megestrol acetate (Megace®), diethyl stilbestrol (DES), or cyproterone acetate; Ketoconazole; 5-alpha-reductase inhibitors (e.g., finasteride [Proscar®], dutasteride [Avodart®]); High dose calcitriol (> 7.0 ug/week)
Cannot have received: investigational vaccine
Treatment with any investigational vaccine within 2 years of registration
Cannot have received: investigational product
treatment with any other investigational product within 28 days of registration
Cannot have received: radiation therapy
Radiation therapy for bone metastasis within 2 weeks or any other radiation therapy within 4 weeks before first dose of study treatment
Lab requirements
Blood counts
ANC ≥ 1,500/mm^3; WBC > 2500/uL; lymphocyte count ≥ 300/uL; platelets ≥ 100,000/mm^3; hemoglobin ≥ 9g/dL (no RBC transfusions within 14 days unless cytopenia is secondary to disease involvement)
Kidney function
Serum creatinine ≤ 1.5 x ULN or creatinine clearance of ≥ 50 mL/min per Cockcroft-Gault formula
Liver function
Total bilirubin ≤ 1.5 x ULN (unless Gilbert's disease, ≤ 3 x ULN); AST ≤ 2.5 x ULN; ALT ≤ 3.0 x ULN; Alkaline phosphatase ≤ 3 x ULN (≤ 5 x ULN with bone metastases)
ANC ≥ 1,500/mm^3; WBC > 2500/uL; lymphocyte count ≥ 300/uL; platelets ≥ 100,000/mm^3; hemoglobin ≥ 9g/dL; Total bilirubin ≤ 1.5 x ULN (unless Gilbert's disease, ≤ 3 x ULN); AST ≤ 2.5 x ULN; ALT ≤ 3.0 x ULN; Alkaline phosphatase ≤ 3 x ULN (≤ 5 x ULN with bone metastases); Serum creatinine ≤ 1.5 x ULN or creatinine clearance of ≥ 50 mL/min per Cockcroft-Gault formula
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope Medical Center · Duarte, California
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