Stereotactic Body Radiotherapy and Lu-PSMA-617 for Locally Advanced Prostate Cancer
This study is investigating a new way to treat locally advanced prostate cancer. It aims to see if using the drug Lu-PSMA-617 (Pluvicto) along with radiation therapy can reduce cancer recurrence and improve quality of life, potentially avoiding long-term androgen deprivation therapy (ADT). You may be eligible if you are at least 18 years old, male, and have confirmed prostate cancer that shows up well on a PSMA PET/CT scan. The study plans to enroll 45 participants. Success will be measured by finding the safest dose of Lu-PSMA-617 and how long participants live without needing ADT after treatment. The current status of this study is unclear.
- Study design
- This is an interventional study, meaning participants will receive specific treatments. It plans to enroll 45 participants.
- What's involved
- Participants will receive one dose of Lu-PSMA-617, followed by 5 radiation treatments over two weeks about 6 weeks later. A second dose of Lu-PSMA-617 will be given 6 weeks after radiation, and some participants may receive a third dose 6 weeks after the second.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will measure how long participants live without needing androgen deprivation therapy for up to 3 years after treatment.
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NCT06574880
STereotActic Body Radiotherapy and 177Lutetium PSMA in Locally Advanced Prostate Cancer
Recruiting
PHASE1Ages 18+InterventionalTreatmentAngela Y. Jia, MD PhDInvestigator-initiated
~45 participants
Updated 2026-05-26 on ClinicalTrials.gov
What's tested:Lu-PSMA-6175-fraction Stereotactic Body Radiation Therapy (SBRT)
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase I: Maximum tolerated dose (MTD) of Lu-PSMA-617
Measured over 4 weeks after final dose of treatment (treatment expected to last up to six months)
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesOhio1
Study leadership
- Angela Y Jia, MD, PhD · PRINCIPAL_INVESTIGATOR · University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
- Daniel E Spratt, MD · STUDY_CHAIR · University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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\*\* \< 2× ULN
Albumin \> 3 g/dL
Aspartate aminotransferase (AST) \< 3× ULN
\*based upon Chronic Kidney Disease- Epidemiology Collaboration (CKD-EPI) equation. Participants with estimated GFR between 50 - 60 mL/min will require a 99mTc-TPA GFR test and only participants with non-obstructive pathology will be included in the study.
\*\* Total bilirubin ≤ 2x ULN (except for participants with known Gilbert's Syndrome ≤ 3x ULN is permitted)
International Prostate Symptoms Score (IPSS) ≤ 15.
Medically fit for treatment and agreeable to follow-up.
Ability to understand and the willingness to sign a written informed consent.
Participants with partners of childbearing potential, agreement to use barrier contraceptive method (condom) and to continue its use for 14 weeks from receiving the last dose of Lu-PSMA-617. Participants must also not donate sperm for 14 weeks from receiving the last dose of Lu-PSMA-617.
Exclusion
Clinical or radiographic evidence of distant metastatic disease (M1a above aortic bifurcation, M1b, or M1c) by any imaging. Participants are allowed to M1a nodal disease that is below the aortic bifurcation. Negative PSMA PET/CT is an acceptable substitute to conventional staging.
Prostate gland size \>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.
What this trial measures
- Phase I: Maximum tolerated dose (MTD) of Lu-PSMA-6174 weeks after final dose of treatment (treatment expected to last up to six months)
The Phase I goal is to determine the maximally tolerated dose (MTD) of Lu-PSMA-617 when administered with prostate SBRT treatment. The MTD will be captured by analyzing the incidence of dose limiting toxicities occurring within the four weeks after the last dose of treatment.
- Phase II: Androgen deprivation therapy (ADT)-free survival3 years post treatment
The Phase II goal is to determine the 3-year rate of ADT-free survival.