xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06033001</url>
    </required_header>
    <id_info>
      <org_study_id>LNTH-PNT2002-EAP01</org_study_id>
      <nct_id>NCT06033001</nct_id>
    </id_info>
    <brief_title>Expanded Access Treatment With [Lu-177]-PNT2002 for Adult Patients With Prostate-Specific Membrane Antigen (PSMA)-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC)</brief_title>
    <official_title>Expanded Access Treatment With [Lu-177]-PNT2002 for Adult Patients With Prostate-Specific Membrane Antigen (PSMA)-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Lantheus Medical Imaging</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>POINT Biopharma</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Lantheus Medical Imaging</source>
    <brief_summary>
      <textblock>
        The purpose of this program is to provide access to [Lu-177]-PNT2002 to patients who have&#xD;
        been diagnosed with prostate-specific membrane antigen (PMSA)-positive castration-resistant&#xD;
        prostate cancer (mCRPC). Patients must have received at least 1 prior androgen pathway&#xD;
        inhibitor (ARPI) and cannot be treated by currently available drugs or clinical trials.&#xD;
  &#xD;
        In this program participants will be administered [Lu-177]-PNT2002 intravenously every 8&#xD;
        weeks (about every 2 months) for 4 cycles, or 8 months of total treatment. During treatment,&#xD;
        participants will be monitored with routine laboratory tests such as:&#xD;
  &#xD;
          -  Hematology blood tests&#xD;
  &#xD;
          -  Clinical Chemistry blood tests&#xD;
  &#xD;
          -  Testosterone/Prostate Antigen levels blood test&#xD;
  &#xD;
          -  Vital signs&#xD;
  &#xD;
          -  Imaging&#xD;
  &#xD;
          -  ECG&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Available</overall_status>
    <study_type>Expanded Access</study_type>
    <has_expanded_access>No</has_expanded_access>
    <expanded_access_info>
      <expanded_access_type_intermediate>Yes</expanded_access_type_intermediate>
    </expanded_access_info>
    <condition>Castration-Resistant Prostatic Cancer</condition>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>[Lu-177]-PNT2002</intervention_name>
      <description>[Lu-177]-PNT2002, is a radiopharmaceutical investigational drug. [Lu-177]-PNT2002 targets a specific protein that is located on the surface of prostate cancer cells called PSMA. [Lu-177]-PNT2002 delivers radiation to your cancer by binding to the PSMA which helps destroy the cancer cells. [Lu-177]-PNT2002 is administered intravenously every 8 weeks (about every 2 months) for 4 cycles, or 8 months of total treatment.</description>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Patient is male aged 18 years or older;&#xD;
  &#xD;
            2. Histological, pathological, and/or cytological confirmation of adenocarcinoma of the&#xD;
               prostate;&#xD;
  &#xD;
            3. Patients must have at least 1 metastatic lesion present on CT, MRI, or bone scan&#xD;
               imaging;&#xD;
  &#xD;
            4. Patients must have progressive mCRPC based on at least 1 of the following criteria:&#xD;
  &#xD;
                 1. Serum/plasma PSA progression defined as increase in PSA greater than 25% and &gt;2&#xD;
                    ng/mL above nadir, confirmed by progression at 2 time points at least 3 weeks&#xD;
                    apart&#xD;
  &#xD;
                 2. Soft-tissue progression defined as an increase ≥20% in the sum of the diameters&#xD;
                    (SOD) (short axis for nodal lesions and long axis for non-nodal lesions) of all&#xD;
                    target lesions based on the smallest SOD since treatment started or the&#xD;
                    appearance of one or a new lesion&#xD;
  &#xD;
                 3. Progression of bone disease defined as the appearance of 2 or more lesions by&#xD;
                    bone scan&#xD;
  &#xD;
            5. Progression on prior treatment with ≥1 ARPI (abiraterone, apalutamide, darolutamide,&#xD;
               enzalutamide ) in nmCRPC, mHSPC or mCRPC;&#xD;
  &#xD;
            6. PSMA-PET scan ([Ga-68]-PSMA-11 or [F-18]-DCFPyL) positive as determined by local&#xD;
               investigator;&#xD;
  &#xD;
                 1. At least 1 PSMA-PET positive lesion for prostate cancer&#xD;
  &#xD;
                 2. Uptake greater than the liver will be used as the reference for determining&#xD;
                    PSMA-PET positivity and uptake less than or equal to the liver will be used as&#xD;
                    the reference for determining PSMA-PET negativity&#xD;
  &#xD;
                 3. All lymph nodes that measure ≥25 mm in short axis on anatomic imaging must be&#xD;
                    PSMA-PET positive&#xD;
  &#xD;
                 4. All bone metastases with soft tissue component(s) ≥10 mm in short axis must be&#xD;
                    PSMA-PET positive (PSMA-negative osseous metastases without a soft tissue&#xD;
                    component do not exclude patients)&#xD;
  &#xD;
                 5. All solid organ metastases (i.e., lung, liver, adrenal glands, etc.) ≥10 mm in&#xD;
                    short axis must be PSMA-PET positive&#xD;
  &#xD;
            7. Castrate levels of circulating testosterone (&lt;1.7 nmol/L or &lt;50 ng/dL);&#xD;
  &#xD;
            8. Patients must have recovered to Grade ≤2 from all clinically significant toxicities&#xD;
               related to; prior therapies (i.e., prior ARPI, chemotherapy, PARPi, radioisotope or&#xD;
               immunotherapy, etc.)&#xD;
  &#xD;
            9. Adequate organ function, independent of transfusion;&#xD;
  &#xD;
               a. Bone marrow reserve&#xD;
  &#xD;
               i. White blood cell (WBC) count ≥2.5 x 109/L OR absolute neutrophil count (ANC) ≥1.5 x&#xD;
               109/L ii. Platelets ≥100 x 109/L iii. Hemoglobin ≥80 g/L or ≥8 g/dL&#xD;
  &#xD;
               b. Liver function&#xD;
  &#xD;
               i. Total bilirubin ≤1.5 x institutional upper limit of normal (ULN). For patients with&#xD;
               known Gilbert's syndrome, ≤3.0 x ULN ii. ALT and AST ≤3.0 x ULN&#xD;
  &#xD;
               c. Renal function&#xD;
  &#xD;
               i. Creatinine clearance ≥50 mL/min based on Cockroft-Gault formula&#xD;
  &#xD;
               d. Albumin ≥30 g/L&#xD;
  &#xD;
           10. Human immunodeficiency virus-infected patients who are healthy and have a low risk of&#xD;
               acquired immunodeficiency syndrome-related outcomes are eligible;&#xD;
  &#xD;
           11. ECOG performance status 0 or 1;&#xD;
  &#xD;
           12. For patients who have partners who are pregnant or of childbearing potential: a condom&#xD;
               is required along with a highly effective contraceptive method during the study and&#xD;
               for 6 months after last study drug administration. Such methods deemed highly&#xD;
               effective include a) combined (estrogen and progestogen containing) hormonal&#xD;
               contraception associated with inhibition of ovulation, b) progestogen-only hormonal&#xD;
               contraception associated with inhibition of ovulation, c) intrauterine device (IUD),&#xD;
               d) intrauterine hormone-releasing system (IUS), e) bilateral tubal occlusion, f)&#xD;
               vasectomy, g) true sexual abstinence: when this is in line with the preferred and&#xD;
               usual lifestyle of the subject [periodic abstinence (e.g., calendar, ovulation,&#xD;
               symptothermal, post-ovulation methods), declaration of abstinence for the duration of&#xD;
               exposure to IMP, and withdrawal are not acceptable methods of abstinence].&#xD;
  &#xD;
           13. Signed Informed Consent Form&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Prior PSMA-targeted radioligand therapy (i.e., [Lu-177]-PSMA-617);&#xD;
  &#xD;
            2. A superscan defined as a bone scan that demonstrates markedly increased skeletal&#xD;
               radioisotope uptake relative to soft tissues in association with absent or faint&#xD;
               genitourinary tract activity;&#xD;
  &#xD;
            3. Patients with a history of central nervous system (CNS) metastases must have received&#xD;
               therapy (surgery, radiotherapy, gamma knife) and be neurologically stable,&#xD;
               asymptomatic, and not receiving corticosteroids for the purposes of maintaining&#xD;
               neurologic integrity;&#xD;
  &#xD;
            4. Patients with epidural disease, canal disease and prior cord involvement are eligible&#xD;
               if those areas have been treated, are stable, and not neurologically impaired. For&#xD;
               patients with parenchymal CNS metastasis (or a history or CNS metastasis), baseline&#xD;
               and subsequent radiological imaging must include evaluation of the brain (MRI&#xD;
               preferred or CT with contrast);&#xD;
  &#xD;
            5. Symptomatic cord compression, or clinical radiologic findings indicative of impending&#xD;
               cord compression;&#xD;
  &#xD;
            6. Any pre-existing symptoms, or concurrent severe and/or uncontrolled medical conditions&#xD;
               such as ureteral obstruction, which in the opinion of the investigator would&#xD;
               compromise safe participation in the [Lu-177]-PNT2002 EAP;&#xD;
  &#xD;
            7. Not able to understand and comply with treatment instructions and requirements;&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <gender_based>Yes</gender_based>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <overall_contact>
      <last_name>Director of Clinical Operations</last_name>
      <phone>646-975-2554</phone>
      <email>david.myl@lantheus.com</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 10, 2023</study_first_submitted>
    <study_first_submitted_qc>September 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>progressive mCRPC</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Prostatic Neoplasms</mesh_term>
      <mesh_term>Prostatic Neoplasms, Castration-Resistant</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06033001
  org study id: LNTH-PNT2002-EAP01
  nct id: NCT06033001
  lead sponsor: 
  collaborator: 
  The purpose of this program is to provide access to [Lu-177]-PNT2002 to patients who have
        been diagnosed with prostate-specific membrane antigen (PMSA)-positive castration-resistant
        prostate cancer (mCRPC). Patients must have received at least 1 prior androgen pathway
        inhibitor (ARPI) and cannot be treated by currently available drugs or clinical trials.
  
        In this program participants will be administered [Lu-177]-PNT2002 intravenously every 8
        weeks (about every 2 months) for 4 cycles, or 8 months of total treatment. During treatment,
        participants will be monitored with routine laboratory tests such as:
  
          -  Hematology blood tests
  
          -  Clinical Chemistry blood tests
  
          -  Testosterone/Prostate Antigen levels blood test
  
          -  Vital signs
  
          -  Imaging
  
          -  ECG
  expanded access type intermediate: Yes
  intervention type: Drug
  intervention name: [Lu-177]-PNT2002
  description: [Lu-177]-PNT2002, is a radiopharmaceutical investigational drug. [Lu-177]-PNT2002 targets a specific protein that is located on the surface of prostate cancer cells called PSMA. [Lu-177]-PNT2002 delivers radiation to your cancer by binding to the PSMA which helps destroy the cancer cells. [Lu-177]-PNT2002 is administered intravenously every 8 weeks (about every 2 months) for 4 cycles, or 8 months of total treatment.
  criteria: 
  gender: Male
  gender based: Yes
  minimum age: 18 Years
  maximum age: N/A
  last name: Director of Clinical Operations
  phone: 646-975-2554
  email: david.myl@lantheus.com
  responsible party type: Sponsor
  mesh term: Prostatic Neoplasms
  mesh term: Prostatic Neoplasms, Castration-Resistant