Actively Recruiting
Schedule De-Escalation of 177Lu-PSMA-617 for the Treatment of Metastatic Castrate Resistant Prostate Cancer
Led by Mayo Clinic · Updated on 2025-09-11
236
Participants Needed
1
Research Sites
295 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase II trial studies how to improve the usage of Lu 177 vipivotide tetraxetan (177Lu-prostate-specific membrane antigen \[PSMA\]-617) for treating patients with castration-resistant prostate cancer that has spread from where it first started (primary site), to other places in the body (metastatic) utilizing a treatment pause after 5 cycles of therapy versus standard continuous treatment for 6 cycles. Lutetium is a radioligand therapy (RLT). RLT uses a small molecule (in this case 177Lu-PSMA-617) that carries a radioactive component to destroy tumor cells. When lutetium is injected into the body, it attaches to the PSMA receptor found on tumor cells. After lutetium attaches to the PSMA receptor, its radiation component destroys the tumor cell. Giving 177Lu-PSMA-617 for 5 cycles versus 6 cycles may better treat patients with metastatic castrate resistant prostate cancer.
CONDITIONS
Official Title
Schedule De-Escalation of 177Lu-PSMA-617 for the Treatment of Metastatic Castrate Resistant Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Scheduled to receive 177Lu-PSMA-617 therapy at Mayo Clinic Rochester
- Have PSMA positive metastatic castration-resistant prostate cancer confirmed by PET scan
- Willing to provide mandatory blood draws for research
- Able to give written informed consent
- Able to complete questionnaires independently or with help
- Willing to return for follow-up visits during active monitoring
- Have lesions with uptake equal to or above liver on cycle 1 post-therapy SPECT
- Have near-complete response on post-therapy SPECT after 2 to 5 cycles of 177Lu-PSMA-617
- No toxicity requiring dose reduction or delay of next treatment cycle
- Hemoglobin of 8 g/dL or higher
- Platelets of 75,000/mm3 or higher
- Neutrophils of 100/mm3 or higher
- Kidney function with estimated glomerular filtration rate less than 50 mL/min times body surface area or creatinine less than or equal to 1.5 times upper limit of normal
- Liver enzymes (AST or ALT) less than or equal to 3 times upper limit of normal
- No other unacceptable toxicity as judged by investigators
- For re-registration: first progression after treatment pause and PSMA avid lesions on PSMA PET with score 2 or higher
You will not qualify if you...
- Have another active cancer requiring treatment such as radiation, chemotherapy, or immunotherapy
- Receiving any other investigational treatment for prostate cancer
- Not recovered from acute effects of prior therapy (except stable grade 1 peripheral neuropathy for at least 3 months)
- Have uncontrolled illness including active infection, psychiatric illness, or social situations that limit compliance
- Have dyspnea at rest needing continuous oxygen
- Unwilling to use adequate contraception if able to father a child
- Have severe systemic illness or other disease making participation unsafe or interfering with safety assessment
- History of heart attack within 6 months or severe heart failure requiring ongoing treatment
- For re-registration: serious adverse effects preventing re-entry
AI-Screening
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Trial Site Locations
Total: 1 location
1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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