Prostate Cancer Clinical Trial
Official title:
PRISMA-PET - Primary Staging of Prostate Cancer: A Randomized Controlled Trial Comparing 18F-PSMA-1007 PET/CT to Conventional Imaging
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.
Status | Recruiting |
Enrollment | 448 |
Est. completion date | October 1, 2030 |
Est. primary completion date | October 1, 2026 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Department of Radiology and Nuclear Medicine | Esbjerg | |
Denmark | Department of Nuclear Medicine | Odense | |
Denmark | Department of Nuclear Medicine | Vejle |
Lead Sponsor | Collaborator |
---|---|
Odense University Hospital | Hospital of South West Jutland, Sygehus Lillebaelt |
Denmark,
Connor MJ, Smith A, Miah S, Shah TT, Winkler M, Khoo V, Ahmed HU. Targeting Oligometastasis with Stereotactic Ablative Radiation Therapy or Surgery in Metastatic Hormone-sensitive Prostate Cancer: A Systematic Review of Prospective Clinical Trials. Eur Urol Oncol. 2020 Oct;3(5):582-593. doi: 10.1016/j.euo.2020.07.004. Epub 2020 Sep 3. — View Citation
Hofman MS, Lawrentschuk N, Francis RJ, Tang C, Vela I, Thomas P, Rutherford N, Martin JM, Frydenberg M, Shakher R, Wong LM, Taubman K, Ting Lee S, Hsiao E, Roach P, Nottage M, Kirkwood I, Hayne D, Link E, Marusic P, Matera A, Herschtal A, Iravani A, Hicks RJ, Williams S, Murphy DG; proPSMA Study Group Collaborators. Prostate-specific membrane antigen PET-CT in patients with high-risk prostate cancer before curative-intent surgery or radiotherapy (proPSMA): a prospective, randomised, multicentre study. Lancet. 2020 Apr 11;395(10231):1208-1216. doi: 10.1016/S0140-6736(20)30314-7. Epub 2020 Mar 22. — View Citation
Klingenberg S, Jochumsen MR, Ulhoi BP, Fredsoe J, Sorensen KD, Borre M, Bouchelouche K. 68Ga-PSMA PET/CT for Primary Lymph Node and Distant Metastasis NM Staging of High-Risk Prostate Cancer. J Nucl Med. 2021 Feb;62(2):214-220. doi: 10.2967/jnumed.120.245605. Epub 2020 May 22. — View Citation
Parker CC, James ND, Brawley CD, Clarke NW, Hoyle AP, Ali A, Ritchie AWS, Attard G, Chowdhury S, Cross W, Dearnaley DP, Gillessen S, Gilson C, Jones RJ, Langley RE, Malik ZI, Mason MD, Matheson D, Millman R, Russell JM, Thalmann GN, Amos CL, Alonzi R, Bahl A, Birtle A, Din O, Douis H, Eswar C, Gale J, Gannon MR, Jonnada S, Khaksar S, Lester JF, O'Sullivan JM, Parikh OA, Pedley ID, Pudney DM, Sheehan DJ, Srihari NN, Tran ATH, Parmar MKB, Sydes MR; Systemic Therapy for Advanced or Metastatic Prostate cancer: Evaluation of Drug Efficacy (STAMPEDE) investigators. Radiotherapy to the primary tumour for newly diagnosed, metastatic prostate cancer (STAMPEDE): a randomised controlled phase 3 trial. Lancet. 2018 Dec 1;392(10162):2353-2366. doi: 10.1016/S0140-6736(18)32486-3. Epub 2018 Oct 21. — View Citation
Shen G, Deng H, Hu S, Jia Z. Comparison of choline-PET/CT, MRI, SPECT, and bone scintigraphy in the diagnosis of bone metastases in patients with prostate cancer: a meta-analysis. Skeletal Radiol. 2014 Nov;43(11):1503-13. doi: 10.1007/s00256-014-1903-9. Epub 2014 May 20. — View Citation
Sprute K, Kramer V, Koerber SA, Meneses M, Fernandez R, Soza-Ried C, Eiber M, Weber WA, Rauscher I, Rahbar K, Schaefers M, Watabe T, Uemura M, Naka S, Nonomura N, Hatazawa J, Schwab C, Schutz V, Hohenfellner M, Holland-Letz T, Debus J, Kratochwil C, Amaral H, Choyke PL, Haberkorn U, Sandoval C, Giesel FL. Diagnostic Accuracy of 18F-PSMA-1007 PET/CT Imaging for Lymph Node Staging of Prostate Carcinoma in Primary and Biochemical Recurrence. J Nucl Med. 2021 Feb;62(2):208-213. doi: 10.2967/jnumed.120.246363. Epub 2020 Aug 17. — View Citation
Torre LA, Bray F, Siegel RL, Ferlay J, Lortet-Tieulent J, Jemal A. Global cancer statistics, 2012. CA Cancer J Clin. 2015 Mar;65(2):87-108. doi: 10.3322/caac.21262. Epub 2015 Feb 4. — View Citation
Zacho HD, Jochumsen MR, Langkilde NC, Mortensen JC, Haarmark C, Hendel HW, Jensen JB, Petersen LJ. No Added Value of 18F-Sodium Fluoride PET/CT for the Detection of Bone Metastases in Patients with Newly Diagnosed Prostate Cancer with Normal Bone Scintigraphy. J Nucl Med. 2019 Dec;60(12):1713-1716. doi: 10.2967/jnumed.119.229062. Epub 2019 May 30. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Accuracy NaF-PET/CT compared to PSMA-PET/CT for detection of metastases | Difference in metastases detection between the two groups | Immediately after staging/up to 1 month after the scan. | |
Other | Value of PSMA/MR for tumor staging and detection of lymph node and bone metastases in the pelvis. | Comparing pathology results with PSMA-PET/MRi for evaluating tumor extension in the prostate gland, and lymph node and bone metastases in the pelvis. | After prostatectomy, up to 3 months after the scan. | |
Primary | Progression Free Survival (Group A vs. B) | Time from treatment with curative intent to progression, eg. time from staging/curative treatment to PSA-value (or other clinical findings) deeming relapse. | 1 to 3 years after staging | |
Secondary | Treatment Strategy (Group A vs. B) | Treatment strategy compared between the two groups. Rate of patients offered prostatectomy, curative radiotherapy, curative intended treatment, castration, up-front chemotherapy) in each group. | Immediately after staging - 1-2 months after the scan. | |
Secondary | Quality of life according to questionnaires (Group A vs. B) | 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%. | 1 to 3 years after staging. Questionnaire: Functional Assessment of Cancer Therapy - Prostate Cancer (FACT-P v. 4) |
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