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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Lu-PSMA-617
DrugLu-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.
5-fraction Stereotactic Body Radiation Therapy (SBRT)
RadiationProstate and nodal SBRT will begin at the completion of cycle 1 (6 weeks after the first Lu-PSMA-617 infusion, ± 4 weeks).
Treatment groups
45 Participants
are divided into 1 treatment groupGroup A: Lu-PSMA-617 + SBRTExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Phase I: Maximum tolerated dose (MTD) of Lu-PSMA-617
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.
Time frame
4 weeks after final dose of treatment (treatment expected to last up to six months)2
Phase II: Androgen deprivation therapy (ADT)-free survival
The Phase II goal is to determine the 3-year rate of ADT-free survival.
Time frame
3 years post treatmentSecondary outcomes
1
PSA Progression Free Survival
PSA progression-free survival will be analyzed at 24 months post last dose of treatment.
Time frame
2 years post treatment2
Overall Survival (OS)
Overall Survival (OS) is defined as the time from Day 1 until death due to any cause. For subjects who do not die, time to death will be censored at the time of last contact.
Time frame
5 years post treatment3
Prostate Cancer-specific Survival (PCSM)
Prostate cancer specific mortality (PCSM) is defined the time from Day 1 to death directly attributable to prostate cancer, death from treatment complications, or death from unknown causes in participants with active prostate cancer or previously documented clinical or biochemical relapse.
Time frame
5 years post treatment4
Cumulative incidence of distant metastases
Distant metastases (DM) is defined as the time from Day 1 until development of distant metastases on CT, MRI, bone scan or PSMA PET, or death from prostate cancer.
Time frame
5 years post treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Angela Y. Jia, MD PhD
Lead sponsor
Case Comprehensive Cancer Center
Sponsor institution
Source ClinicalTrials.gov