Prostate Cancer Clinical Trial
Evaluation of a Flexible Dosing Schedule of 177Lu-PSMA-617 for the Treatment of Metastatic Castration-Resistant Prostate Cancer
Summary
This phase II trial tests how well a flexible dosing schedule of 177Lu-prostate-specific membrane antigen [PSMA]-617) for 12 cycles works compared to the standard schedule of 6 cycles for treating patients with castration-resistant prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Metastatic castration-resistant prostate cancer (mCRPC) keeps growing even when the amount of testosterone in the body is reduced to very low levels. Many early-stage prostate cancers need normal levels of testosterone to grow, but castrate-resistant prostate cancers do not. Because of this, traditional hormone therapy used to manage prostate cancer is no longer effective in stopping or slowing the disease. Lutetium is a radioligand therapy (RLT). RLT uses a small molecule (in this case 177Lu-PSMA-617) that carries a radioactive component to destroy tumor cells. When lutetium is injected into the body, it attaches to the PSMA receptor found on tumor cells. After lutetium attaches to the PSMA receptor, its radiation component destroys the tumor cell. Giving 177Lu-PSMA-617 with a flexible dosing schedule including "treatment holiday" periods may be more effective than traditional therapy in treating patients with metastatic castration-resistant prostate cancer.
Full Description
PRIMARY OBJECTIVE:
I. To assess a potential survival benefit (2-year survival rate) of patients treated with Lu 177 vipivotide tetraxetan (177Lu-PSMA-617) therapy on a flexible dosing schedule including up to 12 cycles and potential "treatment holiday" periods in comparison to patients treated with the standard fixed dosing schedule of maximum 6 treatment cycles every 6 weeks.
SECONDARY OBJECTIVES:
I. To determine the safety of the flexible/extended schedule of 177Lu-PSMA-617 therapy.
II. To compare the overall survival (OS) of the flexible/extended schedule of 177Lu-PSMA-617 therapy to the standard-of-care schedule of 177Lu-PSMA-617 therapy.
III. To compare the progression-free survival (PFS) of the flexible/extended schedule of 177Lu-PSMA-617 therapy to the standard-of-care schedule of 177Lu-PSMA-617 therapy.
IV. To compare the disease control rate (DCR) of the flexible/extended schedule of 177Lu-PSMA-617 therapy to the standard-of-care schedule of 177Lu-PSMA-617 therapy.
V. To compare the impact on bone pain level of the flexible/extended schedule of 177Lu-PSMA-617 therapy to the standard-of-care schedule of 177Lu-PSMA-617 therapy.
VI. To compare the impact on health-related quality of life of the flexible/extended schedule of 177Lu-PSMA-617 therapy to the standard-of-care schedule of 177Lu-PSMA-617 therapy.
EXPLORATORY OBJECTIVE:
I. To determine the dosimetry in organs and tumor lesions of the flexible/extended schedule of 177Lu-PSMA-617 therapy.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive 177Lu-PSMA-617 intravenously (IV) once every 6 weeks on study. Beginning with the third cycle, treatments may be postponed beyond the 6 weeks interval based on defined response criteria ("treatment holiday" period). Treatment repeats every 6 weeks for 12 cycles in the absence of disease progression or unacceptable toxicity. Patients receive gallium Ga 68 gozetotide (68Ga-PSMA-11) IV and undergo prostate-specific membrane antigen positron emission tomography/computed tomography (PSMA PET/CT) throughout the trial. Patients also undergo single photon emission computed tomography (SPECT)/CT, PET/CT, or CT on the trial.
ARM II: Patients receive 177Lu-PSMA-617 IV once every 6 weeks on study. Treatment repeats every 6 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients receive 68Ga-PSMA-11 IV and undergo PSMA PET/CT throughout the trial. Patients also undergo SPECT/CT, PET/CT, or CT on the trial.
Upon completion of study treatment, patients are followed up every 3 months for 24 months from after first cycle of study treatment.
Eligibility Criteria
Inclusion Criteria:
Patients must have prostate cancer proven by histopathology
Patients must have ≥ 1 metastatic lesion by any imaging (CT, magnetic resonance imaging [MRI], bone scan, PET)
Patients must have received at least one regimen of chemotherapy for mCRPC
Patients must have received at least one androgen-receptor signaling inhibitors (ARSI)
Patients must be eligible by PSMA PET VISION criteria. PSMA PET/CT must be performed within 8 weeks of planned first cycle of 177Lu-PSMA-617
White blood cell (WBC) ≥ 1500/ul
Platelets (PLT) ≥ 50.000/ul
Hemoglobin (Hb) ≥ 8.0 g/dl
Absolute neutrophil count (ANC) ≥ 1000 mm^3
Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
Patients must be adults ≥ 18 years of age
Patients must have the ability to understand and sign an approved informed consent form (ICF)
Patients must have the ability to understand and comply with all protocol requirements
Exclusion Criteria:
Prior of 177Lu-PSMA-617 therapy
Less than 6 weeks since last myelosuppressive therapy (including docetaxel, cabazitaxel, strontium-89, samarium-153, rhenium-186, rhenium-188, radium-223, hemi-body irradiation)
Glomerular filtration rate (GFR) < 30 ml/min
Urinary tract obstruction or marked hydronephrosis
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There is 1 Location for this study
Los Angeles California, 90095, United States More Info
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