Metastatic Castration-Resistant Prostate Carcinoma, Stage IVB Prostate Cancer AJCC v8
Conditions
Brief summary
This phase I trial studies the safety, side effects, and treatment cycle 1 best dose of Lu-177-PSMA-617 in patients with prostate cancer that keeps growing even when the amount of testosterone in the body is reduced to very low levels (castration-resistant) and has spread from where it first started (primary site) to other places in the body (metastatic). Lu-177-PSMA-617 is a radioactive drug. It binds to a protein called prostate-specific membrane antigen (PSMA), which is found on prostate cancer tumor cells. Lu-177-PSMA-617 gives off radiation that may kill these tumor cells. It is a type of radioconjugate. Lu-177-PSMA-617 is currently used in a series of 6 intravenous infusions of the standard dosage, each separated by 6 weeks from the previous infusion. Investigators have observed that the first therapy administration (cycle 1) delivers better radiation treatment to the cancer than each of the following 5 infusions. Giving an increased dosage of Lu-177-PSMA-617 in treatment cycle 1 may have a better effect on metastatic castration-resistant prostate cancer than the standard dosage. The study does not change the total cumulative activity from what is used in the standard dosage treatment but gives an increased dosage in cycle 1 and reduces the total number of cycles.
Interventions
PROCEDUREBiospecimen Collection
Undergo collection of urine samples
PROCEDUREComputed Tomography
Undergo SPECT/CT
Given Ga-68 PSMA-11
Given IV
DEVICEPositron Emission Tomography
Undergo PET
OTHERQuestionnaire Administration
Ancillary studies
DEVICESingle Photon Emission Computed Tomography
Undergo SPECT/CT
Given IV
Sponsors
University of Michigan Rogel Cancer Center
National Cancer Institute (NCI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients must be eligible for standard Lu-177-PSMA617 RLT for mCRPC, including PSMA PET/CT scan positive (lesion uptake \> liver uptake by visual assessment) * Patients must have recovered to ≤ Grade 2 from all clinically significant toxicities related to prior therapies (i.e., prior chemotherapy, external beam radiation, brachytherapy, immunotherapy, etc.) * Patients must be ≥18 years of age * Patients must have an ECOG performance status of 0 or 1 * Absolute neutrophil count (ANC) ≥ 1500/mm\^3 * Platelet count ≥ 150,000/mm\^3 * Hemoglobin ≥ 10.0 g/dL * Estimated glomerular filtration rate (EGFR) ≥ 60ml/min * Bilirubin ≤ 1.5 x the institutional upper limit of normal (ULN). For patients with known Gilbert's Syndrome ≤ 3 x ULN is permitted * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 3.0 x ULN OR ≤ 5.0 x ULN for patients with liver metastases * Albumin \> 3.0 g/dL * Use effective birth control methods during the treatment and for 14 weeks after the last Lu-177-PSMA-617 dose * Ability to understand and the willingness to sign a written informed consent
Exclusion criteria
* Does not meet criteria for standard Lu-177-PSMA-617 RLT * Diffuse marrow involvement evident on Ga-68-PSMA PET/CT as assessed by study treating clinician * Prior RLT * Unmanageable concurrent bladder outflow obstruction or urinary incontinence * Concurrent serious (as determined by the Principal Investigator) medical conditions, including, but not limited to, New York Heart Association class III or IV congestive heart failure, history of congenital prolonged QT syndrome, uncontrolled infection, active hepatitis B or C, or other significant co-morbid conditions that in the opinion of the investigator would impair study participation or cooperation * Plan to start any additional anti-cancer therapy or investigational agents during study therapy. Anti-cancer therapies include chemotherapy and endocrine therapy *
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose limiting toxicity (DLT) | up to 6 weeks | The rate of drug-related adverse events that meet protocol-specified dose-limiting criteria and occur during the time period from administration of cycle 1 dosage up to administration of cycle 2 dosage. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of treatment related adverse events | at 6 weeks after first dose and 12 weeks after last dose | Any treatment related adverse events of Grade 3 or higher (according to CTCAE v5.0) from time of cycle 1 administration until time of cycle 2 administration and from time of cycle 1 administration until 12 weeks after the last cycle administration |
| Completion of overall multi-cycle (4-5 cycles) planned treatment course | Up to 30 weeks | To determine the rate of successful completion of the complete planned treatment course (total of 4 or 5 cycles) |
| Biochemical (prostate-specific antigen [PSA]) response | at 6 weeks after first dose and 12 weeks after last dose | Will be estimated as the proportion of patients with ≥ 50% drop in serum PSA levels from baseline to 6 weeks after first cycle and from baseline to 12 weeks after last cycle |
| PSMA PET/CT response | at 6 weeks after first dose and 12 weeks after last dose | Will be estimated as the proportion of patients with ≥ 30% drop in PSMA positive tumor volume on PET/CT from baseline to 6 weeks after first cycle and from baseline to 12 weeks after last cycle |
Countries
United States
Contacts
CONTACTCancer AnswerLine
PRINCIPAL_INVESTIGATORKirk A Frey, MD
University of Michigan Rogel Cancer Center
Outcome results
None listed