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

Study Overview
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Brief Summary
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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.

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

Conditions
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Penile Cancer

Intervention / Treatment
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* Diagnostic Test: Multi-parametric, functional magnetic resonance imaging (MRI)


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with penile squamous cell carcinoma.<br>Patients with penile squamous cell carcinoma. | Diagnostic Test: Multi-parametric, functional magnetic resonance imaging (MRI)<br>* Multi-parametric, functional magnetic resonance imaging (MRI) will be performed in all included patients prior to surgery.<br>|

What is the study measuring?
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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 |