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177Lu-PSMA-617 Managed Access Program for mCRPC Patients

Primary Purpose

Metastatic Castration-resistant Prostate Cancer (mCRPC)

Status
No longer available
Phase
Locations
Study Type
Expanded Access
Intervention
177Lu-PSMA-617
PSMA-11
Sponsored by
Advanced Accelerator Applications
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Metastatic Castration-resistant Prostate Cancer (mCRPC) focused on measuring metastatic castration-resistant prostate cancer, mCRPC, 177Lu-PSMA-617

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)Male

Inclusion Criteria:

  1. Patients must be ≥ 18 years of age.
  2. Patients must have progressive mCRPC. Documented progressive mCRPC will be based on at least 1 of the following criteria:

    • Rising PSA according to PCWG3 criteria (2 rising values above a baseline at a minimum of 1-week intervals) and PSA ≥2.0 ng/mL
    • Soft-tissue progression defined as per prostate cancer working group 3 (PCWG3)-modified RECIST v1.1
    • Progression of bone disease as per PCWG3 criteria
  3. Patients must have mCRPC with histological, pathological, and/or cytological confirmation of adenocarcinoma of the prostate.
  4. Patients must have ≥ 1 metastatic lesion that is present on baseline CT, MRI, or bone scan imaging.
  5. Patients must have prostate-specific membrane antigen (PSMA)- positive prostate cancer, as determined by PSMA-targeted PET / CT scan.
  6. Patients must have a castrate level of serum/plasma testosterone (< 50 ng/dL or < 1.7 nmol/L).
  7. Patients must have received at least one NAAD (such as enzalutamide and/or abiraterone).
  8. Patients must have been previously treated with at least 1, but no more than 2 previous taxane regimens. A taxane regimen is defined as a minimum exposure of 2 cycles of a taxane. If a patient has received only 1 taxane regimen, the patient is eligible if:

    a. The patient's physician deems him unsuitable to receive a second taxane regimen (e.g. frailty assessed by geriatric or health status evaluation, intolerance, etc.).

  9. Patients must have recovered to ≤ Grade 2 from all clinically significant toxicities related to prior therapies (i.e. prior chemotherapy, radiation, immunotherapy, etc.).
  10. Patients must have adequate organ function:

    1. Bone marrow reserve:

      • White blood cell (WBC) count ≥ 2.5 x 10^9/L (2.5 × 10^9/L is equivalent to 2.5 × 10^3/μL and 2.5 × K/μL and 2.5 × 10^3/cumm and 2500/μL) OR absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L (1.5 × 10^9/L is equivalent to 1.5 × 10^3/μL and 1.5 × K/μL and 1.5 × 10^3/cumm and 1500/μL).
      • Platelets ≥ 100 × 10^9/L (100 × 10^9/L is equivalent to 100 × 10^3/μL and 100 × K/μL and 100 × 10^3/cumm and 100 000/μL).
      • Hemoglobin ≥ 9 g/dL (9 g/dL is equivalent to 90 g/L and 5.59 mmol/L).
    2. Hepatic:

      • Total bilirubin ≤ 1.5 × the institutional upper limit of normal (ULN). For patients with known Gilbert's Syndrome ≤ 3 × ULN is permitted.
      • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 × ULN OR ≤ 5.0 × ULN for patients with liver metastases.
    3. Renal:

      • Serum/plasma creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL/min.
      • Albumin > 3.0 g/dL (3.0 g/dL is equivalent to 30 g/L).

Exclusion Criteria:

  1. History of hypersensitivity to any drugs or metabolites of similar chemical classes as Lu-PSMA-617.
  2. Other concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy.
  3. Transfusion for the sole purpose of making a subject eligible for study inclusion.
  4. Patients with a history of central nervous system (CNS) metastases must have received therapy (surgery, radiotherapy, gamma knife) and be neurologically stable, asymptomatic, and not receiving corticosteroids for the purposes of maintaining neurologic integrity.
  5. 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).
  6. Any pre-existing symptoms, or concurrent severe and/or uncontrolled medical conditions which could compromise safe participation in the MAP.
  7. Not able to understand and comply with treatment instructions and requirements.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    March 29, 2021
    Last Updated
    January 12, 2023
    Sponsor
    Advanced Accelerator Applications
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04825652
    Brief Title
    177Lu-PSMA-617 Managed Access Program for mCRPC Patients
    Official Title
    Managed Access Program (MAP) Cohort Treatment Plan [CAAA617A12001M] to Provide Access to 177Lu-PSMA-617 for Patients With Metastatic Castration-resistant Prostate Cancer.
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    January 2023
    Overall Recruitment Status
    No longer available
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Advanced Accelerator Applications

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this Cohort Treatment Plan is to allow access to 177Lu-PSMA-617 for eligible patients diagnosed with metastatic castration-resistant prostate cancer (mCRPC). The patient's treating physician should follow the suggested treatment guidelines and comply with all local health authority regulations.
    Detailed Description
    PSMA-11 will be provided in certain cases where it may be required as a diagnostic imaging agent. PSMA-11 is used to confirm the presence of PSMA positive lesions in patients, which then makes them eligible for treatment with 177Lu-PSMA-617.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Metastatic Castration-resistant Prostate Cancer (mCRPC)
    Keywords
    metastatic castration-resistant prostate cancer, mCRPC, 177Lu-PSMA-617

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    177Lu-PSMA-617
    Intervention Description
    Participants will receive 7.4 GBq (200 mCi) +/- 10% 177Lu-PSMA-617 once every 6 weeks for 6 cycles.
    Intervention Type
    Drug
    Intervention Name(s)
    PSMA-11
    Intervention Description
    Patients will receive a dose of gallium (68Ga) gozetotide that is 1.8-2.2 MBq/kg of body weight (0.049-0.059 mCi/kg), with a minimum dose of 111 MBq (3mCi) up to a maximum dose of 259 MBq (7 mCi).

    10. Eligibility

    Sex
    Male
    Gender Based
    Yes
    Gender Eligibility Description
    patients diagnosed with metastatic castration-resistant prostate cancer (mCRPC)
    Minimum Age & Unit of Time
    18 Years
    Eligibility Criteria
    Inclusion Criteria: Patients must be ≥ 18 years of age. Patients must have progressive mCRPC. Documented progressive mCRPC will be based on at least 1 of the following criteria: Rising PSA according to PCWG3 criteria (2 rising values above a baseline at a minimum of 1-week intervals) and PSA ≥2.0 ng/mL Soft-tissue progression defined as per prostate cancer working group 3 (PCWG3)-modified RECIST v1.1 Progression of bone disease as per PCWG3 criteria Patients must have mCRPC with histological, pathological, and/or cytological confirmation of adenocarcinoma of the prostate. Patients must have ≥ 1 metastatic lesion that is present on baseline CT, MRI, or bone scan imaging. Patients must have prostate-specific membrane antigen (PSMA)- positive prostate cancer, as determined by PSMA-targeted PET / CT scan. Patients must have a castrate level of serum/plasma testosterone (< 50 ng/dL or < 1.7 nmol/L). Patients must have received at least one 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. A taxane regimen is defined as a minimum exposure of 2 cycles of a taxane. If a patient has received only 1 taxane regimen, the patient is eligible if: a. The patient's physician deems him unsuitable to receive a second taxane regimen (e.g. frailty assessed by geriatric or health status evaluation, intolerance, etc.). Patients must have recovered to ≤ Grade 2 from all clinically significant toxicities related to prior therapies (i.e. prior chemotherapy, radiation, immunotherapy, etc.). Patients must have adequate organ function: Bone marrow reserve: White blood cell (WBC) count ≥ 2.5 x 10^9/L (2.5 × 10^9/L is equivalent to 2.5 × 10^3/μL and 2.5 × K/μL and 2.5 × 10^3/cumm and 2500/μL) OR absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L (1.5 × 10^9/L is equivalent to 1.5 × 10^3/μL and 1.5 × K/μL and 1.5 × 10^3/cumm and 1500/μL). Platelets ≥ 100 × 10^9/L (100 × 10^9/L is equivalent to 100 × 10^3/μL and 100 × K/μL and 100 × 10^3/cumm and 100 000/μL). Hemoglobin ≥ 9 g/dL (9 g/dL is equivalent to 90 g/L and 5.59 mmol/L). Hepatic: Total bilirubin ≤ 1.5 × the institutional upper limit of normal (ULN). For patients with known Gilbert's Syndrome ≤ 3 × ULN is permitted. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 × ULN OR ≤ 5.0 × ULN for patients with liver metastases. Renal: Serum/plasma creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL/min. Albumin > 3.0 g/dL (3.0 g/dL is equivalent to 30 g/L). Exclusion Criteria: History of hypersensitivity to any drugs or metabolites of similar chemical classes as Lu-PSMA-617. Other concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy. Transfusion for the sole purpose of making a subject eligible for study inclusion. Patients with a history of central nervous system (CNS) metastases must have received therapy (surgery, radiotherapy, gamma knife) 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). Any pre-existing symptoms, or concurrent severe and/or uncontrolled medical conditions which could compromise safe participation in the MAP. Not able to understand and comply with treatment instructions and requirements.

    12. IPD Sharing Statement

    Learn more about this trial

    177Lu-PSMA-617 Managed Access Program for mCRPC Patients

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