Phase III Randomized Trial of 68Ga-PSMA-11 PET/CT Molecular Imaging for Prostate Cancer Salvage Radiotherapy Planning [PSMA-SRT]


Condition: Recurrent Prostate Carcinoma

Intervention:

  • Drug: 68Ga-PSMA-11

Purpose: To evaluate the success rate of salvage radiation therapy (SRT) for recurrence of prostate cancer after prostatectomy with and without planning based on 68Ga-PSMA-11 PET/CT.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03582774

Sponsor: Jonsson Comprehensive Cancer Center

Primary Outcome Measures:

  • Measure: Rate of biochemical progression-free survival
  • Time Frame: Time Frame: From date of initiation of salvage radiation therapy until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: 5-year progression-free survival rate
  • Time Frame: 5 years
  • Safety Issue:
  • Measure: Metastasis free-survival
  • Time Frame: 5 years
  • Safety Issue:
  • Measure: Rate of additional prostate cancer therapy initiation-free survival
  • Time Frame: assessed up to 5 years
  • Safety Issue:

Estimated Enrollment: 193

Study Start Date: July 12, 2018

Phase: Phase 3

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  • 1. Histopathology proven prostate cancer 2. Planned SRT for recurrence after primary prostatectomy 3. PSA ≥ 0.1ng/ml at time of enrollment 4. Willingness to undergo radiotherapy. 5. 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:

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

Contact:

  • Jeannine Gartmann
  • 310-206-0596

Location:

  • UCLA
  • Los Angeles California 90095 United States

View trial on ClinicalTrials.gov


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