Multicenter Randomized Trial of 68Ga-PSMA-11 PET/CT Based SRT After Radical Prostatectomy

Last updated: August 1, 2024
Sponsor: Jonsson Comprehensive Cancer Center
Overall Status: Active - Not Recruiting

Phase

3

Condition

Prostate Cancer

Prostate Cancer, Early, Recurrent

Urologic Cancer

Treatment

Best Practice

Gallium Ga 68-labeled PSMA-11

Positron Emission Tomography

Clinical Study ID

NCT03582774
18-000484
P30CA016042
18-000484
NUC MED 18-000484
NCI-2018-01518
  • Male

Study Summary

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

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 findingsinto the radiotherapy plan if patient undergoes 68Ga-PSMA-11 PET/CT.

Exclusion

Exclusion Criteria:

  • Extra-pelvic metastasis on any imaging or biopsy.

  • 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.

Study Design

Total Participants: 193
Treatment Group(s): 4
Primary Treatment: Best Practice
Phase: 3
Study Start date:
July 12, 2018
Estimated Completion Date:
July 12, 2026

Study Description

PRIMARY OBJECTIVE:

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

SECONDARY OBJECTIVES:

I. Sub-group analysis of the primary endpoint (success rate of SRT) within the subgroup with baseline PSA ≥ 0.5 ng/ml II. 5-year biochemical progression-free survival rate (from date of randomization).

III. Metastasis free survival. IV. Initiation of additional salvage therapy after completion of SRT. V. 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 periodically for up to 5 years.

Connect with a study center

  • UCLA / Jonsson Comprehensive Cancer Center

    Los Angeles, California 90095
    United States

    Site Not Available

  • UCSF Medical Center-Mount Zion

    San Francisco, California 94115
    United States

    Site Not Available

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