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Prospective Evaluation of 68Ga-PSMA PET-CT for Recurrence Detection of Prostate Cancer and Its Impact on Patient Management (ProsPERo)

Primary Purpose

Prostate Cancers

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
68Ga-(HBED-CC)-PSMA
Sponsored by
Jules Bordet Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancers focused on measuring Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥ 18 years old.
  • Histologically-proven prostate adenocarcinoma.

  • Biochemical recurrence (BCR) after local treatment with radical curative intent based on PSA values 1:

    • Following Radical Prostatectomy +/- Radiotherapy: a serum PSA increase confirmed by a second PSA measurement higher than the first one with a value of 0.2 ng/mL or more within minimum of one week.
    • Following primary Radiotherapy: PSA value of 2 ng/ml above the nadir.
    • A continued rise in PSA level despite treatment with curative intent.

  • Patients with negative, inconclusive or oligometastatic disease on the Routine Imaging Workup and susceptible to be treated with curative radical intent (salvage treatment).

    • Routing Imaging Workup exams are accepted when performed within 1 month before PSMA-PET/CT (this includes WB-MRI, prostatic/pelvic MRI, and/or Bone Scintigraphy).
  • Patient treatment strategy based on routine diagnostic work-up needs to be recorded after discussion at the Urologic Tumor Board and available before the PSMA PET/CT.
  • ECOG performance status ≤ 2
  • Signed informed consent prior to any study related procedure.

Exclusion Criteria:

  • Previous malignancy other than Prostate Cancer (except basocellular or squamous cell skin cancer).
  • Patients treated with palliative chemotherapy or new hormonal therapies like Abiraterone/Enzalutamide.
  • PSA rise while on active treatment (LHRH-agonist, LHRH-antagonist, anti-androgen, maximal androgen blockade, oestrogen). A minimal time window of 1 month is required.
  • Medical castration with Testosterone < 50 ng/dl (1.7 nmol/L).
  • Metastatic patients before inclusion not considered for targeted therapy.
  • Previous treatment with isotopes (Radium, Samarium, Strontium, etc.)
  • All medical conditions that might interfere with the correct performance of imaging scans.
  • Known allergy/sensitivity to 68Ga or HBED-CC coupled substance, or any of the ingredient(s) or excipient(s) of the study medication(s)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Single, arm exploratory

    Arm Description

    Patients will undergo a 68Ga-PSMA PET/CT within 1 month after routine imaging diagnostic work-up.

    Outcomes

    Primary Outcome Measures

    Changes in treatment management are defined as: • Shift to a different therapeutic strategy • Modification of the initial therapeutic strategy • No changes

    Secondary Outcome Measures

    Number of positive scans
    PSMA only positive Routine Imaging only positive Positive in both
    Correlation of positivity with:
    PSA value at the time of imaging PSA doubling time Gleason score
    Reference diagnosis
    Histology when available. Normalisation of PSA level after ablative therapy. Morphological and/or biochemical evolution when no target treatment is given.
    A confirmed PSA response is defined as ≥ 30% reduction of the blood level, compared to the baseline value, confirmed by a second PSA value 4 or more weeks later. PSA responses will be evaluated at for up to 6 months
    Androgen Deprivation Therapy (ADT) free survival: time from final Urologic Tumour Board treatment decision to start of ADT treatment during the follow up period of 6 months
    Time to prostate specific antigen (PSA) progression according to Prostate Cancer Clinical Trials Working Group criteria
    In case of decline from baseline: record time from final Urulogic Tumor Board treatment decision to first PSA increase that is ≥25% and ≥ 2 ng/ml above the nadir OR that is ≥25% above the pretreatment PSA value and which is confirmed by a second value 3 or more weeks later. In case of no decline from baseline: PSA increase that is ≥25% and ≥ 2 ng/ml after 3 months if baseline PSA is ≥2 ng/ml. PSA increase that is ≥25% after 3 months if baseline PSA is < 2 ng/ml.

    Full Information

    First Posted
    June 20, 2016
    Last Updated
    August 21, 2017
    Sponsor
    Jules Bordet Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02810886
    Brief Title
    Prospective Evaluation of 68Ga-PSMA PET-CT for Recurrence Detection of Prostate Cancer and Its Impact on Patient Management
    Acronym
    ProsPERo
    Official Title
    Prospective Evaluation of 68Ga-PSMA-ligand PET-CT for Recurrence Detection of Prostate Cancer and Its Impact on Patient Management
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2017
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Recent publications demonstrating the clinical interest in performing 68Ga-PSMA for recurrence detection of prostate cancer patients with biochemical relapse
    Study Start Date
    October 2016 (Actual)
    Primary Completion Date
    January 20, 2017 (Actual)
    Study Completion Date
    January 20, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Jules Bordet Institute

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Single arm, phase II exploratory trial to prospectively evaluate the impact of 68Ga-PSMA-PET/CT on the therapeutic management of patients with biological recurrent prostate cancer and negative, equivocal or oligometastatic disease after routine imaging diagnostic work-up.
    Detailed Description
    68Ga-PSMA-ligand PET-CT is a recently developed molecular imaging technique. It is based on the prostate specific membrane antigen (PSMA), a transmembrane protein with a large extracellular domain which is over-expressed on prostate cancer cells surface. Initial experiments used a ligand to the extracellular epitope of PSMA and labelled it with the isotope 68Ga, a positron emitter (68Ga-PSMA-HBED-CC) 5. Recently published data based on more than 300 patients show recurrence detection rates and tumour to background ratios higher than choline PET-CT, even at low Prostate Specific Antigen (PSA) levels (sensitivity of 70% in PSA<2ng/ml) 6,7. False-positive PSMA findings are not yet reported. The therapeutic management of biochemical recurrence in prostate cancer depends on the localisation and the extent of the recurrent disease. In this study, the hypothesis is that 68Ga-PSMA-ligand PET-CT, through its high diagnostic accuracy has a significant impact on the therapeutic management of patients with biochemical recurrence. Primary objective: To prospectively evaluate the impact of PSMA-PET/CT on the therapeutic management of patients with biological recurrent prostate cancer and negative, equivocal or oligometastatic disease after routine imaging diagnostic work-up. The treatment management decision will be recorded at the urologic tumor board (UTB) before and after the PSMA-PET/CT result. Rate of decision change will be calculated. Secondary objective(s) To compare detection rates of PSMA PET/CT and Routine Imaging Workup To search for a predictor of a positive PET scan To assess diagnostic value of PSMA-PET/CT To assess PSA response after targeted treatment for oligometastatic disease. To evaluate the delay to start of Androgen Deprivation Therapy (ADT) from the UTB decision. To evaluate the time to PSA progression.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Prostate Cancers
    Keywords
    Prostate Cancer

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Single, arm exploratory
    Arm Type
    Experimental
    Arm Description
    Patients will undergo a 68Ga-PSMA PET/CT within 1 month after routine imaging diagnostic work-up.
    Intervention Type
    Drug
    Intervention Name(s)
    68Ga-(HBED-CC)-PSMA
    Other Intervention Name(s)
    68Ga-PSMA, 68Ga-DKFZ-PSMA-11, 68Ga-PSMA-ligand
    Intervention Description
    68Ga-PSMA-ligand intravenous administration duration is around one minute. Once the patient is injected, the tracer needs 60 minutes to be evenly distributed through the body. PET/CT images will then be performed.
    Primary Outcome Measure Information:
    Title
    Changes in treatment management are defined as: • Shift to a different therapeutic strategy • Modification of the initial therapeutic strategy • No changes
    Time Frame
    2 months
    Secondary Outcome Measure Information:
    Title
    Number of positive scans
    Description
    PSMA only positive Routine Imaging only positive Positive in both
    Time Frame
    2 months
    Title
    Correlation of positivity with:
    Description
    PSA value at the time of imaging PSA doubling time Gleason score
    Time Frame
    2 months
    Title
    Reference diagnosis
    Description
    Histology when available. Normalisation of PSA level after ablative therapy. Morphological and/or biochemical evolution when no target treatment is given.
    Time Frame
    6 months
    Title
    A confirmed PSA response is defined as ≥ 30% reduction of the blood level, compared to the baseline value, confirmed by a second PSA value 4 or more weeks later. PSA responses will be evaluated at for up to 6 months
    Time Frame
    6 months
    Title
    Androgen Deprivation Therapy (ADT) free survival: time from final Urologic Tumour Board treatment decision to start of ADT treatment during the follow up period of 6 months
    Time Frame
    6 months
    Title
    Time to prostate specific antigen (PSA) progression according to Prostate Cancer Clinical Trials Working Group criteria
    Description
    In case of decline from baseline: record time from final Urulogic Tumor Board treatment decision to first PSA increase that is ≥25% and ≥ 2 ng/ml above the nadir OR that is ≥25% above the pretreatment PSA value and which is confirmed by a second value 3 or more weeks later. In case of no decline from baseline: PSA increase that is ≥25% and ≥ 2 ng/ml after 3 months if baseline PSA is ≥2 ng/ml. PSA increase that is ≥25% after 3 months if baseline PSA is < 2 ng/ml.
    Time Frame
    3 months

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age ≥ 18 years old. Histologically-proven prostate adenocarcinoma. Biochemical recurrence (BCR) after local treatment with radical curative intent based on PSA values 1: Following Radical Prostatectomy +/- Radiotherapy: a serum PSA increase confirmed by a second PSA measurement higher than the first one with a value of 0.2 ng/mL or more within minimum of one week. Following primary Radiotherapy: PSA value of 2 ng/ml above the nadir. A continued rise in PSA level despite treatment with curative intent. Patients with negative, inconclusive or oligometastatic disease on the Routine Imaging Workup and susceptible to be treated with curative radical intent (salvage treatment). Routing Imaging Workup exams are accepted when performed within 1 month before PSMA-PET/CT (this includes WB-MRI, prostatic/pelvic MRI, and/or Bone Scintigraphy). Patient treatment strategy based on routine diagnostic work-up needs to be recorded after discussion at the Urologic Tumor Board and available before the PSMA PET/CT. ECOG performance status ≤ 2 Signed informed consent prior to any study related procedure. Exclusion Criteria: Previous malignancy other than Prostate Cancer (except basocellular or squamous cell skin cancer). Patients treated with palliative chemotherapy or new hormonal therapies like Abiraterone/Enzalutamide. PSA rise while on active treatment (LHRH-agonist, LHRH-antagonist, anti-androgen, maximal androgen blockade, oestrogen). A minimal time window of 1 month is required. Medical castration with Testosterone < 50 ng/dl (1.7 nmol/L). Metastatic patients before inclusion not considered for targeted therapy. Previous treatment with isotopes (Radium, Samarium, Strontium, etc.) All medical conditions that might interfere with the correct performance of imaging scans. Known allergy/sensitivity to 68Ga or HBED-CC coupled substance, or any of the ingredient(s) or excipient(s) of the study medication(s)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Carlos Artigas, MD
    Organizational Affiliation
    Jules Bordet Institute
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Prospective Evaluation of 68Ga-PSMA PET-CT for Recurrence Detection of Prostate Cancer and Its Impact on Patient Management

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