Actively Recruiting
Pilot Study of 177Lu-PSMA-617 Combined With Sipuleucel-T in Patients With Metastatic Castration-Resistant Prostate Cancer
Led by City of Hope Medical Center · Updated on 2026-04-20
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
C
City of Hope Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a combination treatment for men with prostate cancer that has spread to other parts of the body and continued to grow despite treatments that lower male hormones. This phase I trial compares the effects of a radioactive drug called lutetium Lu 177 (177^Lu)-PSMA-617 alone and combined with a vaccine therapy called Sipuleucel-T. The goal is to see if the combination can better stimulate the immune system and control the cancer. Participants are randomly assigned to one of two groups. One group receives 177^Lu-PSMA-617 intravenously every 6 weeks for up to 6 cycles, while the other group receives the same radioactive drug plus Sipuleucel-T starting at week 8, given every 2 weeks for up to 3 doses. Both groups undergo various imaging scans such as PET/CT, bone scans, MRI, and blood tests to monitor response and safety throughout the study. During the trial, patients have blood samples taken and may undergo leukapheresis (removal of certain blood cells for vaccine preparation). They are followed closely with scans and clinical visits during treatment and after completion. Follow-up visits occur at 30 days, then every 3 months for up to a year, and every 6 months until disease progression. Researchers measure immune response, safety, tumor response, progression-free survival, and overall survival over up to 3 years of observation.
CONDITIONS
Brief Title
177^Lu-PSMA-617 in Combination With Sipuleucel-T for the Treatment of Metastatic Castration-Resistant Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided informed consent and, if appropriate, assent
- Agreed to allow use of archival tumor tissue or obtained PI approval if unavailable
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Male sex
- Diagnosed with progressive metastatic castration-resistant prostate adenocarcinoma without small cell features
- Have measurable or non-measurable disease as defined by imaging criteria
- On androgen deprivation therapy for at least 3 months and maintaining castrate serum testosterone levels
- Recovered to grade 1 or less toxicity from prior anticancer therapy (except alopecia)
- Meet specific blood count and liver/kidney function requirements within 10 days prior to treatment
- Seronegative or have undetectable viral loads for HIV, hepatitis B/C, and syphilis
- Meet institutional infectious disease testing requirements
- For men with partners of childbearing potential, agree to use effective contraception or abstain through 4 months after last treatment
You will not qualify if you...
- Received approved or investigational anticancer therapy, including chemotherapy or radiation, within 4 weeks prior to study treatment
- Prior treatment with 177Lu-PSMA-617 or sipuleucel-T
- Radiation therapy for bone metastasis within 2 weeks or other radiation within 4 weeks before first dose
- Known significant liver disease
- Received investigational vaccine within 2 years or other investigational product within 28 days of registration
- Diagnosed with certain blood cancers
- Known primary CNS malignancy or symptomatic CNS metastases
- Unable to comply with study and follow-up procedures
- Active malignancy requiring treatment within 3 years except some locally curable cancers
- Other conditions judged by investigator to contraindicate participation
- Anticipated non-compliance with study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 36 weeks for Lutetium Lu 177 Vipivotide Tetraxetan; sipuleucel-T given over approximately 4 weeks starting at week 8
Participants receive intravenous Lutetium Lu 177 Vipivotide Tetraxetan every 6 weeks for up to 6 cycles if there is no disease progression or unacceptable toxicity. Participants in one group also receive sipuleucel-T intravenously starting at week 8, repeated every 2 weeks for up to 3 doses. During treatment, participants undergo blood sample collection, PSMA PET/CT, bone scans, MRI, and possibly brain MRI or CT scans.
Visits every 6 weeks for Lutetium Lu 177 Vipivotide Tetraxetan cycles and visits every 2 weeks for up to 3 sipuleucel-T doses; additional imaging and blood sample collection visits throughout treatment
Duration - Up to 3 years after treatment completion
After completing treatment, participants are followed up at 30 days, every 3 months for up to 1 year, then every 6 months until disease progression. Survival follow-up continues until death or withdrawal of consent.
1 visit at 30 days post-treatment, then visits every 3 months for 1 year, followed by every 6 months thereafter
Trial Site Locations
Total: 1 location
1
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
Research Team
A
Alexander Chehrazi-Raffle, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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