Current Clinical Trials

Note: Some citations in the text of this section are followed by a level of evidence. The PDQ editorial boards use a formal ranking system to help the reader judge the strength of evidence linked to the reported results of a therapeutic strategy. (Refer to the PDQ summary on Levels of Evidence for more information.)

Stage 0 penile cancer is defined by the following TNM classifications:

• Tis, N0, M0
• Ta, N0, M0

Carcinoma in situ of the penis is referred to as erythroplasia of Queyrat when it occurs on the glans, and Bowen disease when it occurs on the penile shaft. These precursor lesions progress to invasive squamous cell carcinoma in 5% to 15% of cases. In case series studies, human papillomavirus DNA has been detected in the majority of these lesions.[1,2] With no data from clinical trials in this disease stage, treatment recommendations are largely based on case reports and case series involving limited numbers of patients.

Treatment options:

1. Surgical excision can result in scarring, deformity, and impaired function. To minimize these effects, Mohs micrographic surgery, which involves the excision of successive horizontal layers of tissue with microscopic examination of each layer in frozen section, has been used in patients with in situ and invasive penile cancers.[3,4][Level of evidence: 3iiiDiv]
2. Topical application of 5-fluorouracil cream has been reported to be effective in cases of erythroplasia of Queyrat [5] and Bowen disease.[6][Level of evidence: 3iiiDiv]
3. Imiquimod 5% cream is a topical immune response modifier that has been reported to be effective with good cosmetic and functional results.[7-9][Level of evidence: 3iiiDiv]
4. Laser therapy with Nd:YAG or CO₂ lasers has also been reported to result in excellent cosmetic results.[10][Level of evidence: 3iiiDiv]
5. Cryosurgery has been reported to result in good cosmetic results in patients with erythroplasia of Queyrat and verrucous penile carcinoma.[11,12][Level of evidence: 3iiiDiv]

Check for U.S. clinical trials from NCI's PDQ Cancer Clinical Trials Registry that are now accepting patients with stage 0 penile cancer. The list of clinical trials can be further narrowed by location, drug, intervention, and other criteria.

General information about clinical trials is also available from the NCI Web site.

References

1. Cupp MR, Malek RS, Goellner JR, et al.: The detection of human papillomavirus deoxyribonucleic acid in intraepithelial, in situ, verrucous and invasive carcinoma of the penis. J Urol 154 (3): 1024-9, 1995.  [PUBMED Abstract]
   
   
2. Rubin MA, Kleter B, Zhou M, et al.: Detection and typing of human papillomavirus DNA in penile carcinoma: evidence for multiple independent pathways of penile carcinogenesis. Am J Pathol 159 (4): 1211-8, 2001.  [PUBMED Abstract]
   
   
3. Mohs FE, Snow SN, Messing EM, et al.: Microscopically controlled surgery in the treatment of carcinoma of the penis. J Urol 133 (6): 961-6, 1985.  [PUBMED Abstract]
   
   
4. Moritz DL, Lynch WS: Extensive Bowen's disease of the penile shaft treated with fresh tissue Mohs micrographic surgery in two separate operations. J Dermatol Surg Oncol 17 (4): 374-8, 1991.  [PUBMED Abstract]
   
   
5. Goette DK, Carson TE: Erythroplasia of Queyrat: treatment with topical 5-fluorouracil. Cancer 38 (4): 1498-502, 1976.  [PUBMED Abstract]
   
   
6. Tolia BM, Castro VL, Mouded IM, et al.: Bowen's disease of shaft of penis. Successful treatment with 5-fluorouracil. Urology 7 (6): 617-9, 1976.  [PUBMED Abstract]
   
   
7. Danielsen AG, Sand C, Weismann K: Treatment of Bowen's disease of the penis with imiquimod 5% cream. Clin Exp Dermatol 28 (Suppl 1): 7-9, 2003.  [PUBMED Abstract]
   
   
8. Micali G, Nasca MR, Tedeschi A: Topical treatment of intraepithelial penile carcinoma with imiquimod. Clin Exp Dermatol 28 (Suppl 1): 4-6, 2003.  [PUBMED Abstract]
   
   
9. Schroeder TL, Sengelmann RD: Squamous cell carcinoma in situ of the penis successfully treated with imiquimod 5% cream. J Am Acad Dermatol 46 (4): 545-8, 2002.  [PUBMED Abstract]
   
   
10. van Bezooijen BP, Horenblas S, Meinhardt W, et al.: Laser therapy for carcinoma in situ of the penis. J Urol 166 (5): 1670-1, 2001.  [PUBMED Abstract]
    
    
11. Michelman FA, Filho AC, Moraes AM: Verrucous carcinoma of the penis treated with cryosurgery. J Urol 168 (3): 1096-7, 2002.  [PUBMED Abstract]
    
    
12. Sonnex TS, Ralfs IG, Plaza de Lanza M, et al.: Treatment of erythroplasia of Queyrat with liquid nitrogen cryosurgery. Br J Dermatol 106 (5): 581-4, 1982.  [PUBMED Abstract]
    
    

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