This phase II trial tests how well 177Lu-PSMA-617 works in treating patients with prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic) and that remains despite treatment (resistant). Lutetium Lu 177 (177Lu), the radioactive (tracer) component being delivered by prostate-specific membrane antigen (PSMA)-617, has physical properties that make it ideal radionuclide (imaging tests that uses a small dose tracer) for treatment of metastatic castrate-resistant prostate cancer (mCRPC). 177Lu-PSMA-617 works by binding to prostate cancer cells and inducing damage to deoxyribonucleic acid (DNA) inside prostate cancer cells. Giving 177Lu-PSMA-617 may improve treatment outcomes for patients with mCRPC.
OUTLINE: Patients receive 177Lu-PSMA-617 intravenously (IV) over 30 minutes on days 1, 8, 50, 57, 99 and 141. Treatment repeats every 7 days for cycles 1 and 3 and every 6 weeks for cycle 2 and subsequent cycles for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo PSMA positron emission tomography/computed tomography (PET/CT) during screening and single photon emission computed tomography (SPECT)/CT on study. Patients also undergo CT or magnetic resonance imaging (MRI), bone scan, as well as blood sample collection throughout the study. After completion of study treatment, patients are followed up at 30 days and then every 12 weeks for up to 2 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
51
Undergo blood sample collection
Undergo bone scan
Undergo SPECT/CT and CT
Given IV
Undergo MRI
Undergo PSMA PET/CT
Ancillary studies
Undergo SPECT/CT
University of California San Francisco
San Francisco, California, United States
RECRUITINGOlive View-University of California Los Angeles Medical Center
Sylmar, California, United States
NOT_YET_RECRUITINGFred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
RECRUITINGProstate-specific antigen (PSA) progression-free survival (PFS)
PSA progression is defined as a rise in PSA at \> 12 weeks by more than 25% and more than 2ng/mL above the nadir (lowest PSA point). Time-to-event endpoints will be analyzed graphically and numerically using the Kaplan-Meier method and summarized in terms of median or 1-year survival point estimates with corresponding 95% confidence intervals.
Time frame: From enrollment to PSA progression or death from any cause, assessed up to 2 years
Incidence of adverse events (AEs)
AEs will be graded in severity according to the Common Terminology Criteria for Adverse Events version 5.0. Will be analyzed descriptively using summaries of counts and proportions of total and type-specific grade 3/4 AEs across cycles. The maximum toxicity grade per patient of each AE will be derived and presented in table format. The number of patients with grade 3 or higher toxicities (for each toxicity type and overall) will be provided. All AEs will be described, including clinically relevant biochemical and hematological values.
Time frame: Up to 30 days post-treatment
PSA50 response
Will be determined if an average of 70% of patients who receive the intensified regimen achieve a ≥ 50% PSA reduction in favor of the intensified regimen based on a 1-sample test of binomial proportions with 1-sided alpha = 5%. Local labs will measure PSA levels. Increases and decreases will be tracked to assess PSA responses as per Prostate Cancer Working Group 3 (PCWG3). Will be summarized as proportions with 95% confidence intervals calculated using Wilson's method and visualized using waterfall plots.
Time frame: Up to 30 days post-treatment
Radiographic progression-free survival
Time to radiographic progression is defined using conventional imaging or death due to any cause, whichever occurs first. Radiographic progression will be assessed per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 for soft tissue and PCWG3 for bone lesions. Will analyzed based on a 1-sample test of binomial proportions with 1-sided alpha = 5%. Time-to-event endpoints will be analyzed graphically and numerically using the Kaplan-Meier method and summarized in terms of median or 1-year survival point estimates with corresponding 95% confidence intervals.
Time frame: From enrollment to radiographic disease progression or death from any cause, assessed up to 2 years
Overall response rate (ORR)
ORR is defined as the proportion of participants with best overall response of complete response (CR) or partial response (PR) as measured by RECIST v1.1 response in soft tissue, lymph node and visceral lesions. Will analyzed based on a 1-sample test of binomial proportions with 1-sided alpha = 5%.
Time frame: Up to 2 years
Duration of response (DOR)
DOR will also be measured in patients with a CR or PR from date of first response to the date of RECIST progression or death. Will analyzed based on a 1-sample test of binomial proportions with 1-sided alpha = 5%.
Time frame: Up to 2 years
Progression-free survival (PFS)
Clinical progression is defined as the development of signs or symptoms related to prostate cancer as assessed by the physician, initiation of other oncologic treatment or death. Will analyzed based on a 1-sample test of binomial proportions with 1-sided alpha = 5%. Time-to-event endpoints will be analyzed graphically and numerically using the Kaplan-Meier method and summarized in terms of median or 1-year survival point estimates with corresponding 95% confidence intervals.
Time frame: From enrolment to first evidence of radiographic or clinical progression, or PSA PFS, assessed up to 2 years
Overall survival
Will analyzed based on a 1-sample test of binomial proportions with 1-sided alpha = 5%. Time-to-event endpoints will be analyzed graphically and numerically using the Kaplan-Meier method and summarized in terms of median or 1-year survival point estimates with corresponding 95% confidence intervals.
Time frame: From enrollment to death from any cause, assessed up to 2 years
Pain score
Pain will be assessed using the Brief Pain Inventory - Short Form to assess the severity of pain and the impact of pain on daily functions. Measured on Scale of 0 to 10, 0 = no pain, 10 = worst pain imaginable. Higher scores reflect more pain severity and more pain interference.
Time frame: Up to 30 days post-treatment
Health-related quality of life: Eastern Cooperative Oncology Group (ECOG) Performance Status scale
Measures one's level of functioning in terms of ability to care for oneself, daily activity, and physical ability (walking, working, etc.) with a range of 0 to 5. A score of 0 indicates performance without restriction whereas a score of 5 indicates death (a higher score indicates worse functioning).
Time frame: Up to 30 days post-treatment
Health-related quality of life (HRQoL): Functional Assessment of Cancer Therapy Prostate (FACT-P)
The FACT-P questionnaire will also be administered to assess the HRQoL of prostate cancer patients. The FACT-P is made up of 2 parts: the Functional Assessment of Cancer Therapy - General (FACT-G) questionnaire with 27 questions, and the Prostate Cancer Subscale (PCS) with an additional 12 questions. The FACT-G questionnaire measures HRQoL in four different domains: Physical well-being, Functional well-being, Emotional well-being, and Social/Family well-being. The PCS is designed specifically to measure prostate cancer-specific quality of life. Descriptive statistics will be used to summarize the original scores, as well as the change from baseline at each assessment point. Each item in both the FACT-G and PCS is rated on a 0 to 4 Likert-type scale, 0 being "not at all" and 4 being "very much", and then combined to produce subscale scores for each domain, as well as global quality of life score, with higher scores representing better quality of life.
Time frame: Up to 30 days post-treatment
Time to pain progression
Will be assessed by participant responses to the Brief Pain Inventory-Short Form. Pain progression is defined as pain worsening of a 2-point or greater increase on question 3 of the inventory. Will be estimated using Kaplan-Meier method. Mean pain scores and corresponding 95% confidence intervals at each cycle will be visualized. Descriptive statistics will be used to summarize the original scores, as well as the change from baseline at each scheduled assessment time point. Additionally, changes from baseline in the scale and subscale values at the time of each assessment will be summarized. Participants with an evaluable baseline score and at least one evaluable post-baseline score during the treatment period will be included in the change from baseline analyses. The number of participants completing each questionnaire and the number of missing or incomplete assessments will be summarized for each scheduled assessment time point.
Time frame: From enrollment to pain progression, assessed up to 30 days post-treatment
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