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

Penile Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05447273
• Other study ID #: 428797
• Status: Recruiting
• Start date: July 15, 2022
• Est. completion date: January 2030

Study information

• Verified date: April 2024
• Source: Oslo University Hospital
• Contact: Marta D Switlyk, MD PhD
• Phone: 47 915 02 770
• Email: marswi[@]ous-hf.no
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 2030
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Penile Cancer
• Penile Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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