PRISMA-PET - Primary Staging of Prostate Cancer With PSMA

NCT05123300 | Terminated DMC

• 1 other identifier: 2020110469
• Study Type: interventional
• Target: 385
• Locations: 1 country
• Sites: 3

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.

Conditions

Prostate Cancer

Keywords

Prostate Cancer; Primary staging; PSMA-PET

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Treatment Strategy (Group A vs. B)

  Immediately after staging - 1-2 months after the scan.

• Quality of life according to questionnaires (Group A vs. B)

  1 to 3 years after staging. Questionnaire: Functional Assessment of Cancer Therapy - Prostate Cancer (FACT-P v. 4)

Other Outcomes (2)

• Accuracy NaF-PET/CT compared to PSMA-PET/CT for detection of metastases

  Immediately after staging/up to 1 month after the scan.

• Value of PSMA/MR for tumor staging and detection of lymph node and bone metastases in the pelvis.

  After prostatectomy, up to 3 months after the scan.

Study Arms (2)

A) Conventional Imaging

NO INTERVENTION

Conventional Imaging with NaF (sodium fluoride)-PET/CT used for staging

B) Interventional Imaging

EXPERIMENTAL

Staging with the interventional18F-PSMA-1007 PET/CT.

Diagnostic Test: 18F-PSMA-1007

Interventions

18F-PSMA-1007 DIAGNOSTIC_TEST

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.

B) Interventional Imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Odense University Hospital: lead
• Sygehus Lillebaelt: collaborator
• Esbjerg Hospital - University Hospital of Southern Denmark: collaborator

Study Sites (3)

Department of Radiology and Nuclear Medicine

Esbjerg, 6700, Denmark

Location

Department of Nuclear Medicine

Odense, 5000, Denmark

Location

Department of Nuclear Medicine

Vejle, 7100, Denmark

Location

Related Publications (8)

• 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.

  PMID: 25651787 BACKGROUND

• 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.

  PMID: 30355464 BACKGROUND

• 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.

  PMID: 32891600 BACKGROUND

• 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.

  PMID: 24841276 BACKGROUND

• 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.

  PMID: 31147402 BACKGROUND

• 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.

  PMID: 32444374 BACKGROUND

• 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.

  PMID: 32209449 BACKGROUND

• 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.

  PMID: 32817141 BACKGROUND

Related Links

• NORDCAN: Cancer Incidence, Mortality, Prevalence and Survival, accessed 2018/09/09
• Guidelines in Prostate Cancer
• Danish clinical Guidelines for Prostate Cancer

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: physician, Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: August 31, 2021
• First Posted: November 17, 2021
• Study Start: October 4, 2021
• Primary Completion: January 21, 2025
• Study Completion: January 30, 2025
• Last Updated: February 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (3)