STereotActic Body Radiotherapy and 177Lutetium PSMA in Locally Advanced Prostate Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorAngela Y. Jia, MD PhD
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Lu-PSMA-617
- 5-fraction Stereotactic Body Radiation Therapy (SBRT)
Treatment groups
45 Participants
are divided into 1 treatment groupSponsors and collaborators
Angela Y. Jia, MD PhD
Lead sponsor
Case Comprehensive Cancer Center
Sponsor institution
Source ClinicalTrials.gov