Clinical trial · Interventional
PRISMA-PET - Primary Staging of Prostate Cancer With PSMA
PRISMA-PET - Primary Staging of Prostate Cancer: A Randomized Controlled Trial Comparing 18F-PSMA-1007 PET/CT to Conventional Imaging
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Due to change of EAU guidelines, where PSMA-PET/CT is now recommended for primary staging of prostate cancer. We do not believe we ethically could continue this protocol, when the new examination, that was our intervention, is now the recommended.
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-PSMA-1007 | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- A) Conventional Imaging
- description
- Conventional Imaging with NaF (sodium fluoride)-PET/CT used for staging
- type
- EXPERIMENTAL
- label
- B) Interventional Imaging
- description
- Staging with the interventional18F-PSMA-1007 PET/CT.
- interventionNames
- Diagnostic Test: 18F-PSMA-1007
Primary outcomes (1)
- measure
- Progression Free Survival (Group A vs. B)
- timeFrame
- 1 to 3 years after staging
- description
- Time from treatment with curative intent to progression, eg. time from staging/curative treatment to PSA-value (or other clinical findings) deeming relapse.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (8)
- BACKGROUNDTorre 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
- BACKGROUNDParker 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
- BACKGROUNDConnor 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
- BACKGROUNDShen 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
- BACKGROUNDZacho 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