Actively Recruiting
STereotActic Body Radiotherapy and 177Lutetium PSMA in Locally Advanced Prostate Cancer
Led by Angela Y. Jia, MD PhD · Updated on 2025-11-24
45
Participants Needed
1
Research Sites
93 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to is to investigate if it is possible to lower the chance of cancer reoccurrence and also preserve quality of life by using the drug Pluvicto instead of androgen-deprivation therapy to the usual radiation therapy for advanced local prostate cancer. Participants will receive one dose of Pluvicto, followed by radiation about 6 weeks later. Radiation therapy will be completed in 5 treatments over the period of 2 weeks. A second dose of Pluvicto will be given 6 weeks after radiation is complete. Some participants may also receive a third dose of Pluvicto, and this would be given 6 weeks after the second dose of Pluvicto.
CONDITIONS
Official Title
STereotActic Body Radiotherapy and 177Lutetium PSMA in Locally Advanced Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant must be 18 years of age or older.
- ECOG performance status of 0 or 1.
- Histologic confirmation of prostate adenocarcinoma.
- PSMA avid disease on PSMA PET/CT with tumor SUVmax of 10 or higher, obtained within 4 months.
- Must have either node positive disease on imaging or at least two of the following: stage cT3a or cT3b, grade group 4 or higher, or PSA of 40 ng/mL or greater.
- Adequate organ and marrow function including hemoglobin above 10 g/dL, white blood cells above 3000/mL, neutrophils 1500/mcL or more, platelets 100,000/mcL or more, creatinine less than 1.5 times upper limit of normal, estimated glomerular filtration rate above 50 mL/min, total bilirubin less than 2 times upper limit of normal (up to 3 times if Gilbert's Syndrome), albumin above 3 g/dL, and AST less than 3 times upper limit of normal.
- International Prostate Symptoms Score (IPSS) of 15 or less.
- Medically fit for treatment and willing to follow up.
- Able to understand and willing to sign informed consent.
- If having a partner of childbearing potential, agrees to use barrier contraception and not donate sperm for 14 weeks after last Lu-PSMA-617 dose.
You will not qualify if you...
- Evidence of distant metastatic disease above the aortic bifurcation.
- Prostate gland size larger than 90 cc.
- Prior head and neck radiation therapy.
- Previous prostate cancer treatment including chemotherapy, radiation, or anti-androgen therapy.
- Use of spironolactone or investigational drugs within 30 days before study treatment.
- Use of oral ketoconazole, estrogens, or radiopharmaceuticals within 3 months before registration or during treatment.
- History of pelvic radiation therapy.
- Participation in another investigational drug study within 6 months.
- Another active cancer within the last 3 years except treated skin or superficial bladder cancer.
- History of myelodysplastic syndrome or acute leukemia.
- History or active Crohn's disease or ulcerative colitis.
- Contraindication or inability to tolerate PSMA/PET imaging.
- Conditions that would prevent study participation as judged by the investigator.
- Inability to follow radiation safety rules at hospital or home.
- Prior radionuclide therapy including 177Lu-PSMA-617.
- Reduced salivary gland function with dry mouth grade higher than 1.
AI-Screening
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Trial Site Locations
Total: 1 location
1
University Hospitals Cleveland Medical Center Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
Research Team
A
Angela Y Jia, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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