STARLiT: STereotActic Body Radiotherapy and 177Lutetium PSMA in Locally Advanced Prostate Cancer: A Phase I/II Trial
Angela Y. Jia, MD PhD
Summary
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.
Description
Prostate cancer is the most common cancer in men worldwide and second leading cause of cancer death in men. The most common treatment for prostate cancer is radiation therapy (RT) plus long-term androgen deprivation therapy (ADT) for 18-36 months with a consideration for the addition of abiraterone acetate. With the introduction of abiraterone and other second generation androgen signaling inhibitors (ARSIs) there is great interest in shortening the duration of systemic therapy. This interest stems from the high toxicity rates of ADT and substantial impact on patient-reported quality of life…
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
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…
Interventions
- DrugLu-PSMA-617
Lu-PSMA will be administered at a fixed dose of 7.4GBq per cycle, on a dose escalation schedule: * Level 0: Lu-PSMA-617 for 1 cycle, followed 6 weeks later by SBRT. * Level 1 (Starting Dose Level): Lu-PSMA-617 for 1 cycle, followed 6 weeks later by SBRT, followed 6 weeks later by cycle 2. * Level 2: Lu-PSMA-617 for 1 cycle, followed 6 weeks later by SBRT, followed 6 weeks later by cycle 2, followed 6 weeks later by cycle 3.
- Radiation5-fraction Stereotactic Body Radiation Therapy (SBRT)
Prostate and nodal SBRT will begin at the completion of cycle 1 (6 weeks after the first Lu-PSMA-617 infusion, ± 4 weeks).
Location
- University Hospitals Cleveland Medical Center Seidman Cancer Center, Case Comprehensive Cancer CenterCleveland, Ohio