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Randomized Trial of PSMA PET Scan Before Definitive Radiation Therapy for Prostate Cancer

About

Brief Summary

This randomized phase III trial studies the success rate of definitive radiation therapy (dRT) for prostate cancer (PCa) with or without planning based on PSMA PET. PSMA- PET-based dRT, may improve radiation therapy planning and patient selection for dRT, and potentially improve its outcome compared to dRT without PSMA PET (standard dRT).

Primary Purpose
Diagnostic
Study Type
Interventional
Phase
Phase III

Eligibility

Gender
Male
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

Inclusion Criteria:

  • Adult male 18 years or older
  • Histopathologically-proven PCa
  • Unfavorable IR to HR disease:
    • Prostate specific antigen (PSA) >= 10 ng/mL
    • Or cT-stage >= 2b
    • Or Gleason grade 3 (4+3=7) or higher
    • Or Gleason grade 2 (3+4=7) AND >= 50% positive biopsy cores
    • Or Decipher Score >= 0.45
  • Treating radiation oncologist intends to incorporate PSMA PET findings into the radiotherapy plan, if patient undergoes PSMA PET (intervention arm 2)
  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study

Exclusion Criteria:

  • Less than 18 years old at the time of investigational product administration
  • Extra-pelvic metastasis (M1 disease) on any imaging or biopsy done before randomization
  • Prior PSMA PET
  • Prior pelvic RT
  • Contraindications to radiotherapy (including active inflammatory bowel disease)
  • Concurrent or prior surgery or systemic therapy for PCa at the time of randomization

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Study Stats
Protocol No.
20-000378
Category
Molecular & Medical Pharmacology
Oncology
Principal Investigator
JEREMIE CALAIS
Contact
JEREMIE CALAIS
Location
  • UCLA Westwood
For Providers
NCT No.
NCT04457245
For detailed technical eligibility, visit ClinicalTrials.gov.