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

Recruiting

• Conditions: Penile Cancer
• Interventions: Diagnostic Test: Multi-parametric, functional magnetic resonance imaging (MRI)

• Registration Number: NCT05447273
• Lead Sponsor: Oslo University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-03
• Study First Submitted QC: 2022-07-03
• Study First Posted: 2022-07-07
• Study Start: 2022-07-15
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-01
• Last Update Posted: 2024-04-03
• Primary Completion: 2025-06
• Study Completion: 2030-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with penile squamous cell carcinoma.	Multi-parametric, functional magnetic resonance imaging (MRI)	Patients with penile squamous cell carcinoma.

Primary Outcome Measures

Name	Time	Method
Functional imaging	2022-2024	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.

Secondary Outcome Measures

Name	Time	Method
Clinical outcome	2022-2030	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.
Functional outcome	2022-2030	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.

Trial Locations

Locations (1)

Oslo University Hospital; 🇳🇴 Oslo, Norway