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PSMA-PET/MRI for Radiation Treatment Planning in Patients With Locally Metastatic Prostate Cancer: A Pilot Study

The University of Alabama at Birmingham logo

The University of Alabama at Birmingham

Status and phase

Completed
Phase 1

Conditions

Metastatic Prostate Cancer

Treatments

Drug: [68Ga]PSMA-PET/MRI or PET/CT

Study type

Interventional

Funder types

Other

Identifiers

NCT04086966
R18-190 IRB-300003826

Details and patient eligibility

About

This pilot study will investigate the use of PSMA-PET/MRI (Positron Emission Tomography/ Magnetic Resonance Imaging)to guide radiation treatment planning in patients with known or suspected locally metastatic prostate cancer at the time of diagnosis. Patients will undergo a single PSMA-PET/MRI (or PET/CT (Computed Tomography) in some circumstances) prior to initiation of treatment. Following development of a PSMA-PET guided radiation treatment plan, therapeutic radiation will be delivered per standard-of-care parameters and assessments of feasibility and tolerability will be performed.

Enrollment

10 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Biopsy-proven treatment-naïve prostate adenocarcinoma with pelvic metastases known to suspected on standard-of-care staging imaging
  • Eligibility and plan to undergo definitive radiation therapy for prostate cancer per established standard-of-care radiation oncology clinical guidelines
  • Be at least 18 years of age

Exclusion criteria

  • Inability to tolerate or undergo PET/MRI or PET/CT
  • Previous or current hematologic or lymphatic disorder (including leukemia, lymphoma, Castleman's disease, etc.)
  • Recurrent prostate adenocarcinoma
  • Known distant metastatic disease
  • Current or prior treatment for prostate cancer
  • Known allergy to glucagon
  • Previous diagnosis of insulinoma or pheochromocytoma

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

10 participants in 1 patient group

Metastatic Prostate Cancer Arm
Experimental group
Description:
\[68Ga\]PSMA-11 PET/MRI or PET/CT for guiding the radiation treatment plan in patients with known or suspected locally metastatic prostate cancer
Treatment:
Drug: [68Ga]PSMA-PET/MRI or PET/CT

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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