NCT05567770

ACTInium-J591 Radionuclide Therapy in PSMA-Detected Metastatic HOrmone-Sensitive Recurrent Prostate CaNcer

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: Male
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety of combining Actinium- J591 with radiation therapy or with androgen deprivation therapy.

Detailed description

This is a two cohort pilot study for patients with hormone-sensitive prostate cancer after primary treatment +/- salvage treatment with metastases detected on PSMA-PET scan but equivocal, indeterminate or absent on conventional imaging. Cohort 1 will have patients with Oligometastatic (low volume, between 1 and 5 metastases) disease and Cohort 2 will have patients with polymetastatic (high volume, ≥5 metastases) disease detected via PSMA PET.

Conditions

• Prostate Cancer Metastatic

Interventions

Type	Name	Description
DRUG	Actinium-J591	Cohort 1 with oligometastatic disease will receive Actinium-J591 and Stereotactic Body Radiation Therapy
RADIATION	Stereotactic Body Radiation Therapy	Cohort 1 patients with oligometastatic disease will receive Actinium-J591 and Stereotactic Body Radiation Therapy
DRUG	Androgen Deprivation Therapy	Cohort 2 patient with Polymetastatic disease will receive Actinium-J591 and Androgen Deprivation therapy (ADT)

Timeline

• Start date: 2023-12-01
• Primary completion: 2025-01-01
• Completion: 2030-01-01
• First posted: 2022-10-05
• Last updated: 2023-08-24

Regulatory

• FDA-regulated drug study