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PRISMA-PET - Primary Staging of Prostate Cancer With PSMA

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05123300
Recruitment Status : Recruiting
First Posted : November 17, 2021
Last Update Posted : April 5, 2024
Sponsor:
Collaborators:
Sygehus Lillebaelt
Hospital of South West Jutland
Information provided by (Responsible Party):
Karen Middelbo Buch-Olsen, Odense University Hospital

Brief Summary:

Early and correct diagnostic staging is paramount to keep patients with newly diagnosed prostate cancer in the correct treatment tract to avoid under- and overdiagnosis in prostate cancer staging. With accurate staging, the investigators aim to save patients from side effects of insufficient or too extensive treatment. The investigators hypothesize that precise staging will lead to optimized individualized treatment and subsequently to prolonged survival and increased quality of life.

Prostate cancer is a very heterogeneous disease varying from indolent tumors to aggressive cancer types. About one-fifth of patients with newly detected high- or intermediate-risk prostate cancer present with bone metastases and their 3-years survival is less than 50%. Precise staging is required for planning relevant treatment that has the potential to increase survival.

The prostate-specific membrane antigen (PSMA) is overexpressed in prostate cancer cells and can serve as a target for precise diagnosis and staging. PSMA-positron emission tomography/computed tomography (PET/CT) has shown to be more accurate than traditional imaging, but there is a need for prospective trials analyzing the impact of primary staging with PSMA-PET/CT on treatment planning and patient benefit.

In a prospective multicenter study, the investigators plan to include 448 patients and randomize 1:1 to either traditional imaging or PSMA-PET/CT. The investigators aim to analyze whether PSMA-PET/CT increases progression-free survival and quality of life. Further, the investigators aim to validate the accuracy of primary staging with PSMA-PET/CT compared with conventional imaging.


Condition or disease Intervention/treatment Phase
Prostate Cancer Diagnostic Test: 18F-PSMA-1007 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 448 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Included patients will be randomized 1:1 into a control group (A) and an interventional group (B). Block randomization will be stratified by high-/intermediate-/low-risk PCa patients. Bone Scan has been substituted with NaF-PET/CT in clinical routine at participating departments, and will as well in this study.

Primary staging in each group will be performed as follows:

  • Group A: CE-CT and NaF-PET/CT (conventional imaging)
  • Group B: 18F-PSMA-1007 PET/CT (interventional imaging) In group B, a sufficient number of patients will have conventional imaging performed (an added NaF-PET/CT), which will be blinded and used for diagnostic accuracy measures. A subset of patients with risk of extracapsular extension planned for radical prostatectomy in group B will also have an 18F-PSMA-PET/MRi-scan performed.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: PRISMA-PET - Primary Staging of Prostate Cancer: A Randomized Controlled Trial Comparing 18F-PSMA-1007 PET/CT to Conventional Imaging
Actual Study Start Date : October 4, 2021
Estimated Primary Completion Date : October 1, 2026
Estimated Study Completion Date : October 1, 2030

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
No Intervention: A) Conventional Imaging
Conventional Imaging with NaF (sodium fluoride)-PET/CT used for staging
Experimental: B) Interventional Imaging
Staging with the interventional18F-PSMA-1007 PET/CT.
Diagnostic Test: 18F-PSMA-1007
18F-PSMA-1007 is a tracer for a PET/CT. Prostate cancer often has marked uptake of PSMA, hence PSMA-PET/CT is in the guidelines in the European Union for detecting relapse. But we will use it for staging primary prostate cancer.




Primary Outcome Measures :
  1. Progression Free Survival (Group A vs. B) [ Time Frame: 1 to 3 years after staging ]
    Time from treatment with curative intent to progression, eg. time from staging/curative treatment to PSA-value (or other clinical findings) deeming relapse.


Secondary Outcome Measures :
  1. Treatment Strategy (Group A vs. B) [ Time Frame: Immediately after staging - 1-2 months after the scan. ]
    Treatment strategy compared between the two groups. Rate of patients offered prostatectomy, curative radiotherapy, curative intended treatment, castration, up-front chemotherapy) in each group.

  2. Quality of life according to questionnaires (Group A vs. B) [ Time Frame: 1 to 3 years after staging. Questionnaire: Functional Assessment of Cancer Therapy - Prostate Cancer (FACT-P v. 4) ]
    Difference in quality of life between the two groups judged by patient reported outcomes in questionnaires, an 8 point difference is considered clinically relevant in FACT-P. Minimum 0 points and maximum 156 points for FACT-P, higher score is worse. Level of significance will be 5%.


Other Outcome Measures:
  1. Accuracy NaF-PET/CT compared to PSMA-PET/CT for detection of metastases [ Time Frame: Immediately after staging/up to 1 month after the scan. ]
    Difference in metastases detection between the two groups

  2. Value of PSMA/MR for tumor staging and detection of lymph node and bone metastases in the pelvis. [ Time Frame: After prostatectomy, up to 3 months after the scan. ]
    Comparing pathology results with PSMA-PET/MRi for evaluating tumor extension in the prostate gland, and lymph node and bone metastases in the pelvis.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Has given informed consent to participate
  • Can read and understand provided patient information material in Danish
  • Biopsy verified PCa
  • Any, some, or all of the following features:

    • Prostatic Specific Antigen (PSA) ≥ 20 ng/ml OR
    • Gleason Score ≥ 4+3 OR
    • Tumor stage clinically judged T2c cancer (cT2c) or above as determined by digital rectal exploration and/or transrectal ultrasonography
    • Suspicion of metastases clinically based on other findings
  • Prostatic Specific Antigen (PSA) ≤ 200 ng/ml
  • Staging by imaging warranted

Exclusion Criteria:

  • Consent not given
  • Inability to read and/or understand provided patient information in Danish
  • Previously given consent but withdrawn for any reason
  • Staging by imaging not warranted as judged clinically
  • Allergy towards contents in the tracer solution

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05123300


Contacts
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Contact: Karen M. Buch-Olsen, MD +45 29 34 69 22 kmbo@rsyd.dk
Contact: Malene Hildebrandt, PhD +45 30 17 18 88 malene.grubbe.hildebrandt@rsyd.dk

Locations
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Denmark
Department of Radiology and Nuclear Medicine Recruiting
Esbjerg, Denmark, 6700
Contact: Mie Ho Vilstrup, MD    2159 3008    mie.holm.vilstrup@rsyd.dk   
Contact    7918 2000      
Department of Nuclear Medicine Recruiting
Odense, Denmark, 5000
Contact: Karen M Buch-Olsen, MD    +45 29346922    kmbo@rsyd.dk   
Contact: Malene G Hildebrandt, PhD, MD    +45 30171888    malene.grubbe.hildebrandt@rsyd.dk   
Department of Nuclear Medicine Recruiting
Vejle, Denmark, 7100
Contact: Paw C Holdgaard, MD    +45 79405812    paw.holdgaard@rsyd.dk   
Contact    +45 79405800      
Sponsors and Collaborators
Odense University Hospital
Sygehus Lillebaelt
Hospital of South West Jutland
  Study Documents (Full-Text)

Documents provided by Karen Middelbo Buch-Olsen, Odense University Hospital:
Additional Information:
Publications:

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Responsible Party: Karen Middelbo Buch-Olsen, physician, Principal Investigator, Odense University Hospital
ClinicalTrials.gov Identifier: NCT05123300    
Other Study ID Numbers: 2020110469
First Posted: November 17, 2021    Key Record Dates
Last Update Posted: April 5, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Karen Middelbo Buch-Olsen, Odense University Hospital:
Prostate Cancer
Primary staging
PSMA-PET
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases