The Role of Functional Magnetic Resonance Imaging in Preoperative Assessment of Primary Penile Carcinoma

The proposed project is intended as a prospective study that includes 60 patients with newly diagnosed penile squamous cell carcinoma (SCC) referred to Oslo University Hospital (OUH), Radiumhospitalet, for surgery, primarily organ-sparing surgery (OSS).

OSS may improve not only quality of life, but also quality of sexual function. However, there is a potential for increased risk of local recurrence after OSS compared to the amputation of the penis. Appropriate preoperative staging, including multi-parametric magnetic resonance imaging (mpMRI), can substantially improve selection of patients and decrease the recurrence rate after surgery.

MpMRI without artificial erection is promising diagnostic tool that is poised to be all-in-one solution for staging and preoperative assessment of primary penile cancer, especially prior to OSS. The method is non-invasive and thus comfortable to perform for most of the patients. Novel MRI techniques are not incorporated into current clinical recommendations, and the potential of new, functional sequences has not been evaluated before. The accuracy of functional, non-erectile mpMRI for detecting and staging of primary penile cancer is not known. Thus, the main purpose of this study is to assess the diagnostic value of this method for preoperative assessment of penile cancer.

Study Overview

• Status: Recruiting
• Conditions: Penile Cancer
• Intervention / Treatment: Diagnostic test: Multi-parametric, functional magnetic resonance imaging (MRI)

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Marta D Switlyk, MD PhD; Phone Number: 47 915 02 770; Email: marswi@ous-hf.no

Study Locations

• Norway
  • Oslo, Norway
    • Recruiting
    • Oslo University Hospital
    • Contact: Marta D Switlyk, MD PhD; Phone Number: +47 915 02 770; Email: marswi@ous-hf.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with newly diagnosed penile squamous cell carcinoma (SCC), referred to surgical treatment.

Description

Inclusion Criteria:

• newly diagnosed penile squamous cell carcinoma (SCC)
• the patient will benefit from organ-sparing surgery (OSS)
• signed broad consent for cancer research

Exclusion Criteria:

• N/A

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with penile squamous cell carcinoma.	Diagnostic test: Multi-parametric, functional magnetic resonance imaging (MRI); Multi-parametric, functional magnetic resonance imaging (MRI) will be performed in all included patients prior to surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional imaging	Assess tumor extent and infiltration depth on multi-parametric MRI (mrT-stage) with histopathological evaluation as a reference standard. Explore usefulness of multi-parametric MRI in assessing inguinal and pelvic lymph nodes (mrN-stage). 2-fluoro-2-deoxy-D-glucose positron emission tomography/computed tomography (FDG PET-CT), sentinel lymph node evaluation and histopathological examination of the resected specimen will be a gold standard.	2022-2024

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical outcome	Assess the locoregional recurrence rate and 5-year survival rate following OSS. Clinical outcome data will be obtained from 5 years clinical follow-up at the Department of Urology OUH.	2022-2030
Functional outcome	Evaluation of urinary and sexual function following surgery. Functional outcome data will be assessed by urologists using a scoring system and according to the clinical practice, and from interviews with clinical sexologist.	2022-2030

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Investigators: Principal Investigator: Marta D Switlyk, MD PhD, Oslo University Hospital

Publications and helpful links

General Publications

• Philippou P, Shabbir M, Malone P, Nigam R, Muneer A, Ralph DJ, Minhas S. Conservative surgery for squamous cell carcinoma of the penis: resection margins and long-term oncological control. J Urol. 2012 Sep;188(3):803-8. doi: 10.1016/j.juro.2012.05.012. Epub 2012 Jul 19.
• Hanchanale V, Yeo L, Subedi N, Smith J, Wah T, Harnden P, Bhattarai S, Chilka S, Eardley I. The accuracy of magnetic resonance imaging (MRI) in predicting the invasion of the tunica albuginea and the urethra during the primary staging of penile cancer. BJU Int. 2016 Mar;117(3):439-43. doi: 10.1111/bju.13041. Epub 2015 Jun 3.
• Cubilla AL, Barreto J, Caballero C, Ayala G, Riveros M. Pathologic features of epidermoid carcinoma of the penis. A prospective study of 66 cases. Am J Surg Pathol. 1993 Aug;17(8):753-63. doi: 10.1097/00000478-199308000-00001.
• Kayes O, Minhas S, Allen C, Hare C, Freeman A, Ralph D. The role of magnetic resonance imaging in the local staging of penile cancer. Eur Urol. 2007 May;51(5):1313-8; discussion 1318-9. doi: 10.1016/j.eururo.2006.11.014. Epub 2006 Nov 13.
• Kieffer JM, Djajadiningrat RS, van Muilekom EA, Graafland NM, Horenblas S, Aaronson NK. Quality of life for patients treated for penile cancer. J Urol. 2014 Oct;192(4):1105-10. doi: 10.1016/j.juro.2014.04.014. Epub 2014 Apr 18.
• Romero FR, Romero KR, Mattos MA, Garcia CR, Fernandes Rde C, Perez MD. Sexual function after partial penectomy for penile cancer. Urology. 2005 Dec;66(6):1292-5. doi: 10.1016/j.urology.2005.06.081.
• Veeratterapillay R, Teo L, Asterling S, Greene D. Oncologic Outcomes of Penile Cancer Treatment at a UK Supraregional Center. Urology. 2015 May;85(5):1097-1103. doi: 10.1016/j.urology.2014.11.048. Epub 2015 Mar 10.
• Petralia G, Villa G, Scardino E, Zoffoli E, Renne G, de Cobelli O, Bellomi M. Local staging of penile cancer using magnetic resonance imaging with pharmacologically induced penile erection. Radiol Med. 2008 Jun;113(4):517-28. doi: 10.1007/s11547-008-0273-6. Epub 2008 May 13. English, Italian.
• Scardino E, Villa G, Bonomo G, Matei DV, Verweij F, Rocco B, Varela R, de Cobelli O. Magnetic resonance imaging combined with artificial erection for local staging of penile cancer. Urology. 2004 Jun;63(6):1158-62. doi: 10.1016/j.urology.2004.01.008.
• Krishna S, Shanbhogue K, Schieda N, Morbeck F, Hadas B, Kulkarni G, McInnes MD, Baroni RH. Role of MRI in Staging of Penile Cancer. J Magn Reson Imaging. 2020 Jun;51(6):1612-1629. doi: 10.1002/jmri.27060. Epub 2020 Jan 24.

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2022
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): January 1, 2030

Study Registration Dates

• First Submitted: July 3, 2022
• First Submitted That Met QC Criteria: July 3, 2022
• First Posted (Actual): July 7, 2022

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Penile Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Penile Neoplasms
• Other Study ID Numbers: 428797

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No