68Ga-PSMA-11 PET / CT in Diagnosing Participants with Recurrent Prostate Cancer After Radical Prostatectomy

Status: Active

Description

This phase III trial studies how well Gallium Ga 68-labeled PSMA-11 (68Ga-PSMA-11) positron emission tomography (PET) / computed tomography (CT) works in diagnosing participants with prostate cancer that has come back after surgery. 68Ga-PSMA-11 are taken up by cancer cells. Diagnostic procedures, such as PET / CT scans, may help find and diagnose prostate cancer and find out how far the disease has spread. Giving 68Ga-PSMA-11 with PET / CT may help doctors plan better for salvage radiation therapy in participants with recurrent prostate cancer.

Eligibility Criteria

Inclusion Criteria

  • Histopathology proven prostate cancer.
  • Planned SRT for recurrence after primary prostatectomy.
  • Prostate-specific antigen (PSA) >= 0.1 ng/ml at time of enrollment.
  • Willingness to undergo radiotherapy.
  • Treating radiation oncologist intends to incorporate 68Ga-PSMA-11 PET/CT findings into the radiotherapy plan if patient undergoes 68Ga-PSMA-11 PET/CT.

Exclusion Criteria

  • Extra-pelvic metastasis on any imaging or biopsy.
  • Prior prostate-specific membrane antigen (PSMA) PET/CT.
  • Prior pelvic external beam radiation therapy (RT).
  • Androgen deprivation therapy (ADT) within 3 months before 68Ga-PSMA-11 PET/CT.
  • Contraindications to radiotherapy (including active inflammatory bowel disease).
  • Concurrent systemic therapy for prostate cancer with investigational agents.

Locations & Contacts

California

Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: Active
Contact: Jeremie Calais
Phone: 310-825-6301

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. Success rate of salvage radiation therapy (SRT) measured as biochemical progression-free survival after initiation of SRT.

SECONDARY OBJECTIVES:

I. 5-year biochemical progression-free survival rate (from date of initiation of SRT).

II. Metastasis free survival.

III. Initiation of additional salvage therapy after completion of SRT.

IV. Change in initial treatment intent.

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I: Participants receive standard of care SRT.

ARM II: Participants receive 68Ga-PSMA-11 intravenously (IV) and 50-100 minutes later undergo whole-body (skull base to mid-thighs) PET/CT. Participants then undergo SRT per the discretion of the treating radiation oncologist.

After conclusion of PET/CT, participants are followed up at 1-3 days and periodically for up to 5 years.

Trial Phase & Type

Trial Phase

No phase specified

Trial Type

Diagnostic

Lead Organization

Lead Organization
UCLA / Jonsson Comprehensive Cancer Center

Principal Investigator
Jeremie Calais

Trial IDs

Primary ID 18-000484
Secondary IDs NCI-2018-01518, NUC MED 18-000484
Clinicaltrials.gov ID NCT03582774