Finding studies
Finding studies
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Shiva Baghaie, MPH
CONTACT
Lead
Alliance for Clinical Trials in Oncology
With
The primary and secondary objectives of the study: PRIMARY OBJECTIVES: I. To compare the overall survival (OS) of patients with metastatic castration-resistant prostate carcinoma (mCRPC) receiving prostate-specific antigen (PSA) adaptive dosing of lutetium 177 Lu prostate specific membrane antigen radioligand therapy (177Lu PSMA RLT) to that of patients receiving standard dose 177Lu PSMA RLT every 6 weeks. II. To compare quality of life, as measured by Functional Assessment of Cancer Therapy- Prostate (FACT-P) total scores averaged across the first 30 months, in patients with mCRPC who receive 177Lu PSMA RLT adaptive dosing versus standard dosing. SECONDARY OBJECTIVES: I. To compare the duration of treatment between standard dosing and adaptive dosing. II. To compare the radiographic progression-free survival (rPFS) between the treatment arms. III. To evaluate and compare the toxicity profile of 177Lu PSMA RLT standard dosing and 177Lu PSMA RLT adaptive dosing. IV. To compare the nadir PSA and PSA kinetics between standard and adaptive dosing. V. To compare quality-adjusted life years, which accounts for overall survival and health utility (measured by European Quality of Life Five Dimension Five Level Scale \[EQ-5D-5L\]), between arms. VI. To compare pain severity, as measured by the Brief Pain Inventory - Short Form (BPI-SF), between arms at 12 and 30 months. EXPLORATORY OBJECTIVES: I. To determine the frequency of tumor genomic aberrations (including but not limited to androgen receptor \[AR\] mutation/amplification, deoxyribonucleic acid \[DNA\] repair, retinoblastoma 1 \[RB1\], phosphatase and tensin homolog \[PTEN\], TP53) by circulating-tumor deoxyribonucleic acid (ctDNA) in patients achieving \> 50% PSA decline versus (vs) \< 50% PSA decline after 2 cycles of 177Lu PSMA RLT. II. To evaluate the relationship between OS and initial PSA response (e.g. ≥ 50% decline in PSA level from baseline \[PSA50\] vs ≥ 75% decline in PSA level from baseline \[PSA75\] vs ≥ 90% decline in PSA level from baseline \[PSA90\]) prior to randomization. OUTLINE: PRE-REGISTRATION STEP 0: Patients receive 177Lu PSMA RLT intravenously (IV) on day 1 of each cycle. Cycles repeat every 6 weeks for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients who achieve a PSA50 response at cycle (C) 2 day (D) 22 proceed to Step 1. RANDOMIZATION STEP 1: Patients are randomized to 1 of 2 arms. ARM 1: Patients receive 177Lu PSMA RLT IV on day 1 of each cycle. Cycles repeat every 6 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity. ARM 2: Starting cycle 2 day 42, patients undergo blood sample collection and PSA monitoring once every 3 weeks (Q3W) in the absence of disease progression or unacceptable toxicity. Patients with either an absolute PSA rise \> 4 ng/dL, PSA rise \> 25% above nadir, or clinical progression receive 177Lu PSMA RLT IV three weeks later. Patients then resume PSA monitoring Q3W with adaptive 177Lu PSMA RLT dosing for up to 4 total doses in the absence of disease progression or unacceptable toxicity. Additionally, all patients undergo blood sample collection, computed tomography (CT), and bone scan throughout the trial and PSMA positron emission tomography (PET) during screening. Patients with a history of brain metastases or with clinical indication also undergo magnetic resonance imaging (MRI) throughout the trial. After completion of study treatment, patients are followed up every 12 weeks until disease progression and then every 6 months thereafter for 5 years following registration.
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted