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Clinical Trial 19701

Cancer Type: Genitourinary
Interventions:

Study Type: Treatment
Phase of Study: Phase III
Investigators:

  • Ghassan El-Haddad

Call 813-745-6100
or 1-800-679-0775
Overview

Study Title

VISION: An International, Prospective, Open-Label, Multicenter, Randomized Phase 3 Study of 177LU-PSMA-617 in the Treatment of Patients with Progressive PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (MCRPC)

Summary

Objective

Primary objective: The primary objective of this study is to compare overall survival (OS) in patients with progressive PSMA-positive mCRPC who receive 177Lu-PSMA-617 in addition to best supportive/standard of care versus patients treated by best supportive/best standard of care alone. Key secondary objectives Key secondary objectives are an arm-to-arm comparison of the following: 1. Radiographic progression-free survival (rPFS) 2. RECIST response to include: a. Overall Response Rate (ORR) as measured by RECIST v1.1 criteria b. Disease control rate (DCR) as measured by RECIST v1.1 criteria 3. Time to a first symptomatic skeletal event (SSE) Additional secondary objectives 1. Safety and tolerability of 177Lu-PSMA-617 2. Periodic assessment of health-related quality of life to evaluate impact of intervention on patient well-being (HRQoL; EuroQol 5-dimensions 5-level [EQ-5D-5L] questionnaire, Functional Assessment of Cancer Therapy Prostate [FACT-P] questionnaire and Brief Pain Inventory Short Form [BPI-SF]) 3. Health Economics 4. Progression-free survival (PFS) (radiographic, clinical, or PSA progression-free survival) 5. Biochemical response as measured by PSA. Alkaline phosphatase [ALP] and lactate dehydrogenase [LDH] levels will also be collected

Inclusion Criteria

  • Patients must have the ability to understand and sign an approved ICF, and comply with all protocol requirements.
  • Patients must be 18 years of age or older.
  • Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
  • Patients must have a life expectancy greater than 6 months.
  • Patients must have histological, pathological, and/or cytological confirmation of prostate cancer.
  • Patients must have a positive 68Ga-PSMA-11 PET/CT scan, as determined by the sponsor's central reader.
  • Patients must have prior orchiectomy and/or ongoing androgen-deprivation therapy and a castrate level of serum testosterone (> Patients must have received at least one Novel Androgen Axis Drug (NAAD) such as enzalutamide and/or abiraterone.
  • Patients must have been previously treated with at least 1, but no more than 2 previous taxane regimens. Some exceptions apply.
  • Patients must have documented progressive Metastatic Castration Resistant Prostate Cancer (mCRPC).
  • Patients must have≥ 1 metastatic lesion that is present on baseline CT, MRI, or bone scan imaging obtained ≤28 days prior to beginning study therapy.
  • Patients must have recovered to ≤ Grade 2 from all clinically significant toxicities related to prior therapies.
  • Patients must have adequate organ function.
  • HIV-infected patients who are healthy and have a low risk of AIDS-related outcomes are included in this trial.
  • For patients who have partners of childbearing potential: partner and/or patient must use a method of birth control with adequate barrier protection, deemed acceptable by the principle investigator during the study and for 3 months after last study drug administration.

  • Exclusion Criteria

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  • Previous treatment with Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223 or hemi-body irradiation within 6 months prior to randomization. Previous PSMA-targeted radioligand therapy is not allowed.
  • Any systemic anti-cancer therapy within 28 days prior to day of randomization.
  • Any investigational agents within 28 days prior to day of randomization.
  • Known hypersensitivity to the components of the study therapy or its analogs.
  • Other concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy.
  • Transfusion within 30 days of randomization.
  • Patients with a history of CNS metastases must have received therapy and be neurologically stable, asymptomatic, and not receiving corticosteroids for the purposes of maintaining neurologic integrity. Patients with epidural disease, canal disease and prior cord involvement are eligible if those areas have been treated, are stable, and not neurologically impaired. For patients with parenchymal CNS metastasis (or a history of CNS metastasis), baseline and subsequent radiological imaging must include evaluation of the brain (MRI preferred or CT with contrast).
  • A superscan as seen in the baseline bone scan.
  • Symptomatic cord compression or clinical or radiologic findings indicative of impending cord compression.
  • Concurrent serious medical conditions.
  • Diagnosed with other malignancies that are expected to alter life expectancy or may interfere with disease assessment. Patients with adequately treated non-melanoma skin cancer, superficial bladder cancer and patients with prior history of malignancy who have been disease free for more than 3 years are eligible.