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177-Lutetium-PSMA Before Stereotactic Body Radiotherapy for the Treatment of Oligorecurrent Prostate Cancer, The LUNAR Study (LUNAR)

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ClinicalTrials.gov Identifier: NCT05496959
Recruitment Status : Recruiting
First Posted : August 11, 2022
Last Update Posted : September 8, 2022
Sponsor:
Collaborator:
POINT Biopharma
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

Brief Summary:
This phase II trial tests whether 177-Lutetium-PSMA given before stereotactic body radiotherapy (SBRT) works to improve cancer control rate in patients with 1-5 prostate cancer tumors that have come back after prior treatment (oligorecurrent). Radioactive drugs, such as 177-Lutetium-PSMA, may carry radiation directly to tumor cells and not harm normal cells. SBRT uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Giving 177-Lutetium-PSMA before SBRT may make the SBRT more effective.

Condition or disease Intervention/treatment Phase
Oligometastatic Prostate Carcinoma Prostate Adenocarcinoma Recurrent Prostate Adenocarcinoma Stage IVB Prostate Cancer AJCC v8 Drug: Lutetium Lu-177 PNT2002 Other: Quality-of-Life Assessment Radiation: Stereotactic Body Radiation Therapy Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 177-Lutetium-PSMA Neoadjuvant to Ablative Radiotherapy for Oligorecurrent Prostate Cancer (Lunar)
Actual Study Start Date : September 2, 2022
Estimated Primary Completion Date : September 1, 2024
Estimated Study Completion Date : September 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Lutetium

Arm Intervention/treatment
Active Comparator: Arm 1 (SBRT)
Beginning on day 1, patients undergo SBRT to all lesions for 1, 3, or 5 treatment doses (fractions) over the span of 10-20 days in the absence of disease progression or unacceptable toxicity.
Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Radiation: Stereotactic Body Radiation Therapy
Undergo SBRT
Other Names:
  • SABR
  • SBRT
  • Stereotactic Ablative Body Radiation Therapy

Experimental: Arm 2 (177Lu-PNT2002, SBRT)
Patients receive 177Lu-PNT2002 IV over 1-10 minutes on days -112 and -56 in the absence of disease progression or unacceptable toxicity. Beginning on day 1, patients then undergo SBRT to all lesions for 1, 3, or 5 treatment doses (fractions) over the span of 10-20 days in the absence of disease progression or unacceptable toxicity.
Drug: Lutetium Lu-177 PNT2002
Given IV
Other Names:
  • 177Lu-labeled PNT2002
  • 177Lu-PNT2002
  • [Lu-177]-PNT2002
  • [Lu-177]-PSMA-I and T
  • Lu177-PNT2002
  • Lutetium Lu-177-PNT2002

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Radiation: Stereotactic Body Radiation Therapy
Undergo SBRT
Other Names:
  • SABR
  • SBRT
  • Stereotactic Ablative Body Radiation Therapy




Primary Outcome Measures :
  1. Prostate-specific membrane antigen positron emission tomography/computerized tomography (PSMA PET/CT)-based progression-free survival (PFS) [ Time Frame: Time from the date of stereotactic body radiotherapy (SBRT) completion to the date of disease progression or death, whichever happens earlier, assessed up to 24 months ]
    Will compare PSMA PET/CT-based PFS for patients with oligoprogressive prostate cancer treated with SBRT to all known sites of disease on PSMA PET/CT versus patients treated with 177Lu-PNT2002 prior to SBRT to all known sites of disease. PSMA PET/CT-based progression is defined as either (a) a new lesion on PSMA PET/CT with or without a serum prostate-specific antigen (PSA) increase or (b) local progression on PSMA (> 30% increase in lesion standard uptake value [SUV] or increase of > 20% in the sum of the longest diameter of all target lesions), regardless of new lesions, and a serum PSA increase. A serum PSA increase for the purposes of this definition will be based on the definition of PSA-based progression. The Kaplan-Meier (KM) method will be used to summarize PFS and log-rank test will be used to compare PFS between the two arms.


Secondary Outcome Measures :
  1. Disease progression [ Time Frame: At 24 months ]
    Progression as based PSMA PET/CT scan (with progression). Will be analyzed descriptively.

  2. PSA-based progression [ Time Frame: Up to 24 months ]
    Defined as follows: (a) For pre-enrollment PSA < 0.5 ng/mL, PSA-based progression defined as 0.2 ng/mL increase and (b) For pre-enrollment PSA >= 0.5 ng/mL, PSA-based progression defined as 50% increase over pre-treatment value.

  3. Incidence of adverse events (AEs) [ Time Frame: Up to 60 months ]
    Acute and late physician-scored toxicity Common Terminology Criteria for Adverse Events (CTCAE version 5.0 scale). AEs will be summarized by type and grade. All patients who receive at least one fraction of SBRT in the control arm will be evaluable for toxicity from the time of their first treatment from SBRT; all patients who receive 177Lu-PNT2002 in the experimental arm will be evaluable for toxicity from the time of their first treatment with 177Lu-PNT2002.

  4. Patient-reported quality of life as reported by the Brief Pain Inventory form [ Time Frame: Baseline up to 1 year ]

    Quality of life following SBRT versus 177Lu-PNT2002 +SBRT will be evaluated based on responses to the Brief Pain Inventory form, which will be tabulated at baseline and each follow-up visit (3 months, 6 months, 9 months and 1 year).

    The Brief Pain Inventory is a self-administered 9-item questionnaire, tabular scored from 0 - 130 with lower scores indicating a better outcome.


  5. Androgen deprivation therapy-free survival (ADT-FS) [ Time Frame: Time from starting treatment to the time of initiation of palliative ADT, assessed up to 60 months ]
    The KM method will be used to summarize ADT-FS.

  6. Time to progression [ Time Frame: Time from completing SBRT to the time of first documented tumor progression or new lesions by PSMA PET/CT or initiation of ADT, assessed up to 60 months ]
  7. Time to local progression (TTLP) [ Time Frame: Time from completing SBRT to identification of progression of treated lesions, assessed up to 60 months ]
    The KM method will be used to summarize TTLP.

  8. Time to new metastasis (TNM) [ Time Frame: Time from completing SBRT to the time of a new documented tumor metastasis by PSMA PET/CT, assessed up to 24 months ]
    The KM method will be used to summarize TNM.

  9. Overall survival (OS) [ Time Frame: Time from starting treatment until death due to any cause, assessed up to 60 months ]
    The KM method will be used to summarize OS.

  10. Local control (LC) [ Time Frame: Time from starting treatment until local relapse is documented by PSMA PET/CT based criteria, assessed up to 24 months ]
    The KM method will be used to summarize LC.

  11. Regional control (RC) [ Time Frame: Time from starting treatment until regional relapse is documented by PSMA PET/CT based criteria, assessed up to 24 months ]
    failure in an adjacent lymph node region (for nodal targets) detected by PSMA PET/CT

  12. Duration of complete response (CR) or partial response (PR) [ Time Frame: From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that current or progressive disease is objectively documented, assessed up to 60 months ]
    The KM method will be used to summarize the duration of complete or partial response.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Oligorecurrent prostate cancer as determined by the presence of 1-5 asymptomatic lesions outside the prostate or prostate bed identified on PSMA PET/CT by local readers
  • Age >= 18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status =< 2
  • No indication for urgent or emergent radiation
  • Histologic confirmation of prostate adenocarcinoma (histology from original treatment acceptable)
  • White blood cell count >= 2.5 × 10^9/L
  • Platelets >= 100 × 10^9/L
  • Hemoglobin >= 9 g/dL
  • Total bilirubin =< 1.5 × institutional upper limit of normal (ULN); or up to 3 × ULN if known history of Gilbert's syndrome
  • Alanine aminotransferase or aspartate aminotransferase =< 3.0 × ULN or =< 5.0 × ULN for patients with liver metastases
  • Serum creatinine =< 1.5 × ULN or creatinine clearance >= 50 mL/min
  • Serum albumin > 3.0 g/dL
  • Partner and patient must use a method of birth control with adequate barrier protection, deemed acceptable by the principal investigator during the study and for 3 months after last study drug administration
  • Ability to understand, and willingness to sign, the written informed consent

Exclusion Criteria:

  • Patients with neuroendocrine or small cell carcinoma of the prostate
  • Patients with castrate-resistant disease (i.e., PSA > 0.5 ng/mL with serum testosterone < 150 ng/dL)
  • Patients who received androgen deprivation therapy within 6 months of trial enrollment
  • Concurrent systemic therapy for a solid organ malignancy
  • Spinal cord compression
  • Inability to lie flat
  • Known hypersensitivity to components of 177Lu-PNT2002
  • Serum creatinine > 1.5 × ULN or creatinine clearance < 50 mL/min
  • Total bilirubin > 1.5 × ULN or > 3.0 × ULN if known history of Gilbert's syndrome
  • Alanine aminotransferase or aspartate aminotransferase > 3 × ULN (or 5 × ULN for patients with known liver metastases)
  • De novo oligometastatic disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05496959


Contacts
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Contact: Vince Basehart 310-267-8954 VBasehart@mednet.ucla.edu
Contact: Christie Palodichuk 310-267-8988 cpalodichuk@mednet.ucla.edu

Locations
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United States, California
UCLA / Jonsson Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90095
Contact: Vince Basehart    310-267-8954    vbasehart@mednet.ucla.edu   
Principal Investigator: Amar Kishan, MD         
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
POINT Biopharma
Investigators
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Principal Investigator: Amar Kishan, MD UCLA / Jonsson Comprehensive Cancer Center
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Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT05496959    
Other Study ID Numbers: 22-000750
NCI-2022-05748 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: August 11, 2022    Key Record Dates
Last Update Posted: September 8, 2022
Last Verified: September 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Adenocarcinoma
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type