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A Phase II Study of AAA617 Alone and AAA617 in Combination With ARPI in Patients With PSMA PET Scan Positive CRPC

Status
Active
Cancer Type
Trial Phase
Phase II
Eligibility
18 - 100 Years, Male
Study Type
Treatment
NCT ID
NCT05849298
Protocol IDs
CAAA617B12203 (primary)
NCI-2024-10339
2022-503040-41-00
Study Sponsor
Novartis Pharmaceuticals Corporation

Summary

The purpose of this study is to evaluate the efficacy and safety of AAA617 alone
(Lutetium [177Lu] vipivotide tetraxetan) and in combination with an Androgen Receptor
Pathway Inhibitors (ARPI) in participants with PSMA-positive, castration-resistant
prostate cancer and no evidence of metastasis in conventional imaging (CI) (i.e., CT/MRI
and bone scans). Approximately 120 participants will be randomized.

Eligibility

  1. Participants must be adults = 18 years of age with signed informed consent prior to participation to study
  2. Histologically or cytologically confirmed prostate cancer
  3. Participants must have ongoing androgen deprivation therapy with a GnRH agonist/antagonist or prior bilateral orchiectomy
  4. Castrate level of serum testosterone (< 1.7 nmol/l [50 ng/dl]) on GnRH agonist or antagonist therapy or after bilateral orchiectomy
  5. Participants must have evidence of PSMA-positive disease as seen on a AAA517 or piflufolastat F 18 PET/CT scan at baseline as determined by Blinded Independent Central Review (BICR) based on the methodology proposed in the Prostate Cancer Molecular Imaging Standardized Evaluation (PROMISE) (Eiber et al 2018). Participants with M1 disease only on PSMA PET scan are allowed to participate
  6. Participants must have a negative conventional imaging for M1 disease.
  7. PSA Doubling Time (PSADT) of = 10 months
  8. Participants must have adequate organ functions: bone marrow reserve, hepatic & renal Key

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