PRISMA-PET - Primary Staging of Prostate Cancer With PSMA
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ClinicalTrials.gov Identifier: NCT05123300 |
Recruitment Status :
Recruiting
First Posted : November 17, 2021
Last Update Posted : April 5, 2024
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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 |
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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:
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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 |
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Arm | Intervention/treatment |
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No Intervention: A) Conventional Imaging
Conventional Imaging with NaF (sodium fluoride)-PET/CT used for staging
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Experimental: B) Interventional Imaging
Staging with the interventional18F-PSMA-1007 PET/CT.
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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. |
- 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.
- 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.
- 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%.
- 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
- 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.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Has given informed consent to participate
- Can read and understand provided patient information material in Danish
- Biopsy verified PCa
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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
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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
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 |
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 |
Documents provided by Karen Middelbo Buch-Olsen, Odense University Hospital:
Publications:
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Prostate Cancer Primary staging PSMA-PET |
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms |
Genital Diseases, Male Genital Diseases Urogenital Diseases Prostatic Diseases Male Urogenital Diseases |