STereotActic Body Radiotherapy and 177Lutetium PSMA in Locally Advanced Prostate Cancer

About This Trial

This clinical trial is testing whether combining a targeted radiation drug called Pluvicto with focused radiation can safely lower the chance of cancer returning while helping patients avoid the side effects of standard hormone therapy.
It is for adults with advanced prostate cancer that has spread into nearby tissues or lymph nodes but not to distant parts of the body, and who have not yet received treatment for their prostate cancer.
Participants will receive two or three doses of the drug spaced several weeks apart, alongside five radiation sessions completed over two weeks.
Before considering this study, patients should know that they will need to follow radiation safety precautions at home and use condoms for birth control for a few months following treatment.

More Information

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.

Who Can Enroll

Age Range: 18 years and older
Gender: Male
Who This Trial is For: This clinical trial is testing whether combining a targeted radiation drug called Pluvicto with focused radiation can safely lower the chance of cancer returning while helping patients avoid the side effects of standard hormone therapy.

Study Details

Start Date: May 13, 2025
Lead Sponsor: Angela Y. Jia, MD PhD

Full Eligibility Criteria

Inclusion Criteria

Participant must be ≥ 18 years of age.
ECOG performance status ≤ 1
Histologic confirmation of prostate adenocarcinoma of the prostate
PSMA avid disease on PSMA PET/CT, where the tumor in the prostate has SUVmax ≥ 10.
- PSMA PET/CT must be obtained within 4 months.
Need ≥ 1 criteria:
- Node positive disease on PSMA PET/CT or conventional imaging, as defined by having any of the following:
  - Pelvic nodal disease (cN1) as defined by LN stations that commence at the bifurcation of the common iliac vessels
  - Regional nodal disease (M1a) as defined by LN stations that commence at the bifurcation of the aorta and bifurcation of the proximal inferior vena cava to the common iliac veins.
- In the absence of nodal metastasis, must have ≥ 2 of the following
  - i. cT3a or cT3b by conventional imaging (MRI) or PSMA PET/CT
  - ii. Grade group ≥ 4
  - iii. PSA ≥ 40 ng/mL
Adequate organ and marrow function to receive treatment:
- Hemoglobin > 10 g/dL
- White blood cell (WBC) > 3000 / mL
- Absolute neutrophil count ≥ 1,500 / mcL
- Platelets ≥ 100,000 / mcL
- Creatinine ≤ 1.5x ULN
- Estimated glomerular filtration rate (eGFR)* > 50 mL/min
- Total bilirubin** 3 g/dL
- Aspartate aminotransferase (AST) 90 cc measured by CT, ultrasound, or MRI
Prior head and neck radiation therapy.
Prior treatment for prostate cancer (incudes chemotherapy, radiation therapy, or anti-androgen therapy).
Prohibited within 30 days prior to administration to study treatment: spironolactone and other investigational drug therapies.
Prohibited 3 months before participant registration and during administration of study treatment: oral ketoconazole, , estrogens, and radiopharmaceuticals.
History of prior pelvic radiation therapy.
Enrollment concurrently in another investigational drug study within 6 months of registration.
History of another active malignancy within the previous 3 years except for adequately treated skin cancer or superficial bladder cancer.
History of prior myelodysplastic syndrome or acute leukemia.
History of or active Crohn's disease or ulcerative colitis.
Contraindication to or inability to tolerate PSMA/PET.
Any condition that in the opinion of the investigator would preclude participation in this study.
Inability to adhere to radiation safety measures in hospital or at home
Prior treatment with radionuclide therapies, 177Lu-PSMA-617 or other
Reduced salivary gland function with baseline CTCAE Gr > 1 dry mouth will be excluded.