Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
500 participants
OBSERVATIONAL
2021-05-01
2028-12-31
Brief Summary
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Detailed Description
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Patients with mCRPC who have have progression or intolerance on a novel anti-androgen targeted agent (abiraterone and/or enzalutamide and/or apalutamide) will be eligible for the study.
The investigators intend to evaluate the safety of 177Lu-PSMA, in addition to determining patient PSA progression-free survival (PFS), objective radiographic response rates and overall survival (OS). Health-related quality of life (QoL) and pain will also be observed. Additional objectives are to identify biomarkers and assess the relationship between PSMA and F-fluorodeoxyglucose (FDG) Positron Emission Tomography-Computed Tomography (PET/CT) parameters associated with clinical outcomes.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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177Lu-PSMA
Lu-PSMA will be administered as a standard-of-care procedure following assessment of suitability by a nuclear medicine physician and managed in close collaboration with the patient's medical oncologist.
Eligibility Criteria
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Inclusion Criteria
2. Progression or intolerance on a novel anti-androgen therapy (e.g. abiraterone, enzalutamide, apalutamide or darolutamide)
3. Prior therapy with at least one taxane cytotoxic (these agents may have been received upfront for metastatic hormone-sensitive prostate cancer) or the patient is symptomatic and assessed as unfit for chemotherapy
4. Referred to nuclear medicine and being considered for Lu-PSMA therapy according to institutional procedure guidelines
18 Years
MALE
No
Sponsors
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Peter MacCallum Cancer Centre, Australia
OTHER
Responsible Party
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Locations
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Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PMC 20/164
Identifier Type: -
Identifier Source: org_study_id
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