Summary

Eligibility
for males ages 18-100 (full criteria)
Location
at UCSF
Dates
study started
completion around
Principal Investigator
by Steven Seyedin (ucsf)

Description

Summary

The purpose of this study is to evaluate the efficacy and safety of lutetium (177Lu) vipivotide tetraxetan (AAA617) in participants with oligometastatic prostate cancer (OMPC) progressing after definitive therapy to their primary tumor. The data generated from this study will provide evidence for the treatment of AAA617 in early-stage prostate cancer patients to control recurrent tumor from progressing to fatal metastatic disease while preserving quality of life by delaying treatment with androgen deprivation therapy (ADT).

Official Title

An International, Prospective, Open-label, Multi-center, Randomized Phase III Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) Versus Observation to Delay Castration or Disease Recurrence in Adult Male Patients With Prostate-specific Membrane Antigen (PSMA) Positive Oligometastatic Prostate Cancer (OMPC)

Details

Keywords

Oligometastatic Prostate Cancer (OMPC), Lutetium (177Lu) vipivotide tetraxetan, Metastasis Free Survival (MFS), gallium (68Ga) gozetotide, piflufolastat (18F), prostate-specific membrane antigen (PSMA), Delay Castration, Stereotactic Body Radiation Therapy (SBRT), metastasis-directed therapy, Androgen Deprivation Therapy (ADT)-free survival., Prostatic Neoplasms, 1,4,7,10-tetraazacyclododecane- 1,4,7,10-tetraacetic acid, AAA617

Eligibility

Locations

  • UCSF accepting new patients
    San Francisco California 94115 United States
  • Stanford University accepting new patients
    Palo Alto California 94304 United States

Lead Scientist at University of California Health

  • Steven Seyedin (ucsf)
    Assistant Professor, Radiation Oncology, School of Medicine

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Novartis Pharmaceuticals
ID
NCT05939414
Phase
Phase 3 Prostate Cancer Research Study
Study Type
Interventional
Participants
Expecting 450 study participants
Last Updated