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

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ClinicalTrials.gov Identifier: NCT03582774
Recruitment Status : Active, not recruiting
First Posted : July 11, 2018
Last Update Posted : October 14, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

Tracking Information
First Submitted Date  ICMJE June 19, 2018
First Posted Date  ICMJE July 11, 2018
Last Update Posted Date October 14, 2020
Actual Study Start Date  ICMJE July 12, 2018
Estimated Primary Completion Date July 12, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 9, 2020)
Success rate of salvage radiation therapy (SRT) [ Time Frame: From date of initiation of SRT assessed up to 5 years ]
Will be measured as biochemical progression-free survival after initiation of SRT. Will use a log rank test to compare progression free survival time between the two randomized treatment arms.
Original Primary Outcome Measures  ICMJE
 (submitted: June 27, 2018)
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 ]
Success rate of SRT measured as biochemical progression-free survival after initiation of SRT. Biochemical progression is defined by PSA ≥ 0.2 ng/mL and rising after completion of SRT
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 9, 2020)
  • Biochemical progression-free survival rate [ Time Frame: From date of randomization assessed up to 5 years ]
    Will utilize Cox-proportional hazards regression models. These models will include terms for treatment as well as appropriate clinical/demographic covariates (e.g., androgen deprivation therapy [ADT], pelvic lymph node radiation therapy [LN RT], prostate specific antigen [PSA] doubling time, Gleason grade, T stage, age, etc). Residual analyses will be performed to evaluate the proportional hazards assumptions of the Cox model. As a sensitivity analysis, we will also consider survival models that can account for competing risks (ex. death from other causes).
  • Metastasis free survival [ Time Frame: Up to 5 years ]
    Will utilize Cox-proportional hazards regression models. These models will include terms for treatment as well as appropriate clinical/demographic covariates (e.g., ADT, pelvic LN RT, PSA doubling time, Gleason grade, T stage, age, etc). Residual analyses will be performed to evaluate the proportional hazards assumptions of the Cox model. As a sensitivity analysis, we will also consider survival models that can account for competing risks (ex. death from other causes).
  • Initiation of additional salvage therapy after completion of SRT [ Time Frame: Up to 5 years ]
    Will utilize Cox-proportional hazards regression models. These models will include terms for treatment as well as appropriate clinical/demographic covariates (e.g., ADT, pelvic LN RT, PSA doubling time, Gleason grade, T stage, age, etc). Residual analyses will be performed to evaluate the proportional hazards assumptions of the Cox model. As a sensitivity analysis, we will also consider survival models that can account for competing risks (ex. death from other causes).
  • Change in initial treatment intent [ Time Frame: Up to 5 years ]
    Will utilize Cox-proportional hazards regression models. These models will include terms for treatment as well as appropriate clinical/demographic covariates (e.g., ADT, pelvic LN RT, PSA doubling time, Gleason grade, T stage, age, etc). Residual analyses will be performed to evaluate the proportional hazards assumptions of the Cox model. As a sensitivity analysis, we will also consider survival models that can account for competing risks (ex. death from other causes).
Original Secondary Outcome Measures  ICMJE
 (submitted: June 27, 2018)
  • 5-year progression-free survival rate [ Time Frame: 5 years ]
    5-year biochemical progression-free survival rate (from date of initiation of SRT)
  • Metastasis free-survival [ Time Frame: 5 years ]
    Diagnostic of extra-pelvic metastatic (M1) disease can be obtained by any imaging or biopsy
  • Rate of additional prostate cancer therapy initiation-free survival [ Time Frame: assessed up to 5 years ]
    From the initiation of salvage radiation therapy until the first documented initiation of any additional prostate cancer treatment
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Multicenter Randomized Trial of 68Ga-PSMA-11 PET/CT Based SRT After Radical Prostatectomy
Official Title  ICMJE Phase III Randomized Multicenter Trial of 68Ga-PSMA-11 PET/CT Molecular Imaging for Prostate Cancer Salvage Radiotherapy Planning [PSMA-SRT]
Brief 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.
Detailed 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Recurrent Prostate Carcinoma
Intervention  ICMJE
  • Other: Best Practice
    Undergo standard of care
    Other Names:
    • standard of care
    • standard therapy
  • Procedure: Computed Tomography
    Undergo PET/CT
    Other Names:
    • CAT
    • CAT Scan
    • Computerized Axial Tomography
    • Computerized Tomography
    • CT
    • CT Scan
    • tomography
  • Radiation: Gallium Ga 68-labeled PSMA-11
    Given IV
    Other Names:
    • (68)Ga labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC
    • (68)Ga-labeled Glu-urea-Lys(Ahx)-HBED-CC
    • (68)Ga-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC
    • (68)Gallium-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC
    • (68Ga)Glu-urea-Lys(Ahx)-HBED-CC
    • 68Ga-DKFZ-PSMA-11
    • 68Ga-HBED-CC-PSMA
    • 68Ga-labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC
    • 68Ga-PSMA
    • 68Ga-PSMA-11
    • 68Ga-PSMA-HBED-CC
    • [68Ga] Prostate-specific Membrane Antigen 11
    • [68Ga]GaPSMA-11
    • Ga PSMA
    • Ga-68 labeled DKFZ-PSMA-11
    • Ga-68 labeled PSMA-11
    • Gallium Ga 68 PSMA-11
    • Gallium-68 PSMA
    • Gallium-68 PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC
    • GaPSMA
    • PSMA-HBED-CC GA-68
  • Procedure: Positron Emission Tomography
    Undergo PET/CT
    Other Names:
    • Medical Imaging, Positron Emission Tomography
    • PET
    • PET Scan
    • Positron Emission Tomography Scan
    • Positron-Emission Tomography
    • proton magnetic resonance spectroscopic imaging
Study Arms  ICMJE
  • Active Comparator: Arm I (standard of care)
    Participants receive standard of care SRT.
    Intervention: Other: Best Practice
  • Experimental: Arm II (68Ga-PSMA-11 PET/CT)
    Participants receive 68Ga-PSMA-11 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.
    Interventions:
    • Procedure: Computed Tomography
    • Radiation: Gallium Ga 68-labeled PSMA-11
    • Procedure: Positron Emission Tomography
Publications * Calais J, Czernin J, Fendler WP, Elashoff D, Nickols NG. Randomized prospective phase III trial of (68)Ga-PSMA-11 PET/CT molecular imaging for prostate cancer salvage radiotherapy planning [PSMA-SRT]. BMC Cancer. 2019 Jan 7;19(1):18. doi: 10.1186/s12885-018-5200-1. Erratum in: BMC Cancer. 2019 Jan 21;19(1):97.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: June 27, 2018)
193
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 12, 2024
Estimated Primary Completion Date July 12, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03582774
Other Study ID Numbers  ICMJE 18-000484
NCI-2018-01518 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
NUC MED 18-000484
18-000484 ( Other Identifier: UCLA / Jonsson Comprehensive Cancer Center )
P30CA016042 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jonsson Comprehensive Cancer Center
Study Sponsor  ICMJE Jonsson Comprehensive Cancer Center
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Jeremie Calais UCLA / Jonsson Comprehensive Cancer Center
PRS Account Jonsson Comprehensive Cancer Center
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP