National Cancer Institute


Expert-reviewed information summary about the treatment of penile cancer.

This PDQ cancer information summary for health professionals provides comprehensive, peer-reviewed, evidence-based information about the treatment of penile cancer. It is intended as a resource to inform and assist clinicians who care for cancer patients. It does not provide formal guidelines or recommendations for making health care decisions.

This summary is reviewed regularly and updated as necessary by the PDQ Adult Treatment Editorial Board, which is editorially independent of the National Cancer Institute (NCI). The summary reflects an independent review of the literature and does not represent a policy statement of NCI or the National Institutes of Health (NIH).

Penile Cancer Treatment

General Information About Penile Cancer

Incidence and Mortality

Estimated new cases and deaths from penile (and other male genital) cancer in the United States in 2017:

  • New cases: 2,120.
  • Deaths: 360.

Risk Factors

Penile cancer is rare in most developed nations, including the United States, where the rate is less than 1 per 100,000 men per year. Some studies suggest an association between human papillomavirus (HPV) infection and penile cancer. Observational studies have shown a lower prevalence of penile HPV in men who have been circumcised (odds ratio, 0.37; 95% confidence interval, 0.16–0.85). Some, but not all, observational studies also suggest that male newborn circumcision is associated with a decreased risk of penile cancer. According to published data, if the relationship is causal, the number needed to treat was about 909 circumcisions to prevent a single case of invasive penile cancer.

Treatment Overview

When diagnosed early (stage 0, stage I, and stage II), penile cancer is highly curable. Curability decreases sharply for stage III and stage IV. Because of the rarity of this cancer in the United States, clinical trials specifically for penile cancer are infrequent. Patients with stage III and stage IV cancer can be candidates for phase I and phase II clinical trials testing new drugs, biologicals, or surgical techniques to improve local control and distant metastases.

The selection of treatment depends on the following:

  • Size.
  • Location.
  • Invasiveness.
  • Stage of the tumor.

Cellular Classification of Penile Cancer

Virtually all penile carcinomas are of squamous cell origin and include the following subtypes:

  • Verrucous carcinoma.
  • Warty carcinoma (verruciform).
  • Basaloid carcinoma.

Although they are less common subtypes, warty carcinoma and basaloid carcinoma appear to be more highly associated with human papillomaviruses (HPV), particularly HPV 16, than typical squamous cell carcinoma or verrucous carcinoma of the penis.

In addition, neuroendocrine carcinomas can also be seen.

Stage Information for Penile Cancer

Definitions of TNM

The American Joint Committee on Cancer (AJCC) has designated staging by TNM classification to define penile cancer.

Additional Descriptor. The m suffix indicates the presence of multiple primary tumors and is recorded in parentheses – e.g., pTa (m) N0M0.

Stage 0 Penile Cancer

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

  • Tis, N0, M0
  • Ta, N0, M0

Carcinoma 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. 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:

Current Clinical Trials

Check the list of NCI-supported cancer clinical trials 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 website.

Stage I Penile Cancer

Stage I penile cancer is defined by the following TNM classification:

  • T1a, N0, M0

Stage I penile cancer is curable.

Standard treatment options:

Treatment options under clinical evaluation:

  • Nd:YAG laser therapy has offered excellent control/cure with preservation of cosmetic appearance and sexual function.

Because of the high incidence of microscopic node metastases, elective adjunctive inguinal dissection of clinically uninvolved (negative) lymph nodes in conjunction with amputation is often used for patients with poorly differentiated tumors. Lymphadenectomy can carry substantial morbidity, such as infection, skin necrosis, wound breakdown, chronic edema, and even a low, but finite, mortality rate. The impact of prophylactic lymphadenectomy on survival is not known. For these reasons, opinions vary on its use.

Current Clinical Trials

Check the list of NCI-supported cancer clinical trials that are now accepting patients with stage I 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 website.

Stage II Penile Cancer

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

  • T1b, N0, M0
  • T2, N0, M0
  • T3, N0, M0

Standard treatment options:

  • Stage II penile cancer is most frequently managed by penile amputation for local control. Whether the amputation is partial, total, or radical will depend on the extent and location of the neoplasm. External-beam radiation therapy and brachytherapy with surgical salvage are alternative approaches.

Treatment options under clinical evaluation:

  • Nd:YAG laser therapy has been used to preserve the penis in selected patients with small lesions.

Because of the high incidence of microscopic node metastases, elective adjunctive dissection of clinically uninvolved (negative) lymph nodes in conjunction with amputation is often used for patients with poorly differentiated tumors. Lymphadenectomy, can carry substantial morbidity, such as infection, skin necrosis, wound breakdown, chronic edema, and even a low, but finite, mortality rate. The impact of prophylactic lymphadenectomy on survival is not known.

To reduce the morbidity associated with prophylactic lymphadenectomy, dynamic sentinel node biopsy is being used in patients with stage T2 clinically node-negative penile cancer. One retrospective single-institution study of 22 patients reported a false-negative rate of 11%.

Current Clinical Trials

Check the list of NCI-supported cancer clinical trials that are now accepting patients with stage II 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 website.

Stage III Penile Cancer

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

  • T1–3, N1, M0
  • T1–3, N2, M0

Inguinal adenopathy in patients with penile cancer is common but may be the result of infection rather than neoplasm. If palpable enlarged lymph nodes exist 3 or more weeks after removal of the infected primary lesion and completion of a course of antibiotic therapy, bilateral inguinal lymph node dissection should be performed.

In cases of proven regional inguinal lymph node metastasis without evidence of distant spread, bilateral ilioinguinal dissection is the treatment of choice. Since many patients with positive lymph nodes are not cured, clinical trials may be appropriate.

Standard treatment options:

Treatment options under clinical evaluation:

  • Clinical trials using radiosensitizers or cytotoxic drugs are appropriate. A combination of vincristine, bleomycin, and methotrexate has been effective as both neoadjuvant and adjuvant therapy. Cisplatin (100 mg/m²) as neoadjuvant therapy plus continuous-infusion 5-fluorouracil has also been shown to be effective. Single-agent cisplatin (50 mg/m) was tested in a large trial and was found to be ineffective.

Because of the high incidence of microscopic node metastases, adjunctive inguinal dissection of clinically uninvolved (negative) lymph nodes in conjunction with amputation is often used for patients with poorly differentiated tumors. Lymphadenectomy can carry substantial morbidity, such as infection, skin necrosis, wound breakdown, chronic edema, and even a low, but finite, mortality rate. The impact of prophylactic lymphadenectomy on survival is not known.

To reduce the morbidity associated with prophylactic lymphadenectomy, dynamic sentinel node biopsy is being used in patients with stage T2 and stage T3 clinically node-negative penile cancer. One retrospective single-institution study of 22 patients reported a false-negative rate of 11%.

Current Clinical Trials

Check the list of NCI-supported cancer clinical trials that are now accepting patients with stage III 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 website.

Stage IV Penile Cancer

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

  • T4, Any N, M0
  • Any T, N3, M0
  • Any T, Any N, M1

No standard treatment exists that is curative for patients with stage IV penile cancer. Therapy is directed at palliation, which may be achieved either with surgery or radiation therapy.

Standard treatment options:

Treatment options under clinical evaluation:

  • Clinical trials combining chemotherapy with palliative methods of local control are appropriate for such patients (tested chemotherapeutic drugs with some efficacy include vincristine, cisplatin, methotrexate, and bleomycin). The combination of vincristine, bleomycin, and methotrexate has been effective both as adjuvant and neoadjuvant therapy.

Current Clinical Trials

Check the list of NCI-supported cancer clinical trials that are now accepting patients with stage IV 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 website.

Recurrent Penile Cancer

Locally recurrent disease can be approached by surgery or radiation therapy. If the initial treatment of radiation therapy fails, patients are often salvaged by penile amputation. Patients with nodal recurrences that are not controllable by local measures are candidates for phase I and phase II clinical trials testing new biologicals and chemotherapeutic agents.

Current Clinical Trials

Check the list of NCI-supported cancer clinical trials that are now accepting patients with recurrent 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 website.

Changes to This Summary (02/03/2017)

The PDQ cancer information summaries are reviewed regularly and updated as new information becomes available. This section describes the latest changes made to this summary as of the date above.

General Information About Penile Cancer

Updated statistics with estimated new cases and deaths for 2017 (cited American Cancer Society as reference 1).

This summary is written and maintained by the PDQ Adult Treatment Editorial Board, which is editorially independent of NCI. The summary reflects an independent review of the literature and does not represent a policy statement of NCI or NIH. More information about summary policies and the role of the PDQ Editorial Boards in maintaining the PDQ summaries can be found on the About This PDQ Summary and PDQ® - NCI's Comprehensive Cancer Database pages.

About This PDQ Summary

Purpose of This Summary

This PDQ cancer information summary for health professionals provides comprehensive, peer-reviewed, evidence-based information about the treatment of penile cancer. It is intended as a resource to inform and assist clinicians who care for cancer patients. It does not provide formal guidelines or recommendations for making health care decisions.

Reviewers and Updates

This summary is reviewed regularly and updated as necessary by the PDQ Adult Treatment Editorial Board, which is editorially independent of the National Cancer Institute (NCI). The summary reflects an independent review of the literature and does not represent a policy statement of NCI or the National Institutes of Health (NIH).

Board members review recently published articles each month to determine whether an article should:

  • be discussed at a meeting,
  • be cited with text, or
  • replace or update an existing article that is already cited.

Changes to the summaries are made through a consensus process in which Board members evaluate the strength of the evidence in the published articles and determine how the article should be included in the summary.

The lead reviewer for Penile Cancer Treatment is:

  • Franco M. Muggia, MD (New York University Medical Center)

Any comments or questions about the summary content should be submitted to Cancer.gov through the NCI website's Email Us. Do not contact the individual Board Members with questions or comments about the summaries. Board members will not respond to individual inquiries.

Levels of Evidence

Some of the reference citations in this summary are accompanied by a level-of-evidence designation. These designations are intended to help readers assess the strength of the evidence supporting the use of specific interventions or approaches. The PDQ Adult Treatment Editorial Board uses a formal evidence ranking system in developing its level-of-evidence designations.

Permission to Use This Summary

PDQ is a registered trademark. Although the content of PDQ documents can be used freely as text, it cannot be identified as an NCI PDQ cancer information summary unless it is presented in its entirety and is regularly updated. However, an author would be permitted to write a sentence such as “NCI’s PDQ cancer information summary about breast cancer prevention states the risks succinctly: [include excerpt from the summary].”

The preferred citation for this PDQ summary is:

PDQ® Adult Treatment Editorial Board. PDQ Penile Cancer Treatment. Bethesda, MD: National Cancer Institute. Updated . Available at: https://www.cancer.gov/types/penile/hp/penile-treatment-pdq. Accessed . [PMID: 26389381]

Images in this summary are used with permission of the author(s), artist, and/or publisher for use within the PDQ summaries only. Permission to use images outside the context of PDQ information must be obtained from the owner(s) and cannot be granted by the National Cancer Institute. Information about using the illustrations in this summary, along with many other cancer-related images, is available in Visuals Online, a collection of over 2,000 scientific images.

Disclaimer

Based on the strength of the available evidence, treatment options may be described as either “standard” or “under clinical evaluation.” These classifications should not be used as a basis for insurance reimbursement determinations. More information on insurance coverage is available on Cancer.gov on the Managing Cancer Care page.

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