Revised 19 April 2010

1. Diagnosis

Diagnostic Pathology

1. History and physical examination
2. Clinical staging
3. Culture of lesion
4. CT scan pelvis (invasive lesions)
5. Chest X-ray if indicated

2. Staging

Classification Criteria

T - Primary Tumour

• TX: Primary tumour cannot be assessed
• T0: No evidence of primary tumour
• Tis: Carcinoma in situ
• Ta: Non-invasive verrucous carcinoma
• T1: Tumour invades subepithelial connective tissue
• T2: Tumour invades corpus spongiosum or cavernosum
• T3: Tumour invades urethra or prostate
• T4: Tumour invades other adjacent structures

N - Regional Lymph Nodes

Regional Nodes: Superficial and deep inguinal, and pelvic nodes.

• NX: Regional lymph nodes cannot be assessed
• N0: No regional lymph node metastasis
• N1: Metastasis in a single superficial inguinal lymph node
• N2: Metastasis in multiple or bilateral superficial inguinal nodes
• N3: Metastasis in deep inguinal or pelvic lymph node(s), unilateral or bilateral

M - Distant Metastasis

• MX: Presence of distant metastasis cannot be assessed
• M0: No distant metastasis
• M1: Distant metastasis

Staging Diagram

3. Management

Tis, Ta N0 M0 Stage 0

Excision with an adequate margin. Laser therapy in selected cases.

T1 N0 M0 Stage I and T2 N0 M0 early Stage II

1. Circumcision for preputial lesions
2. Partial penectomy (2 cm proximal to the lesion)
3. Radiotherapy: external beam or brachytherapy

In patients who have undergone partial penectomy, we recommend short-term antibiotic therapy and reassessment in six weeks. Regional superficial node dissection recommended for T2 or greater lesions and non-palpable lymph nodes. If after six weeks, nodes are palpable in an inguinal region, we recommend modified bilateral inguinal lymph node dissection. Regional XRT for palliation of unresectable lymph nodes. If the node biopsy is negative, no further therapy is indicated.

Penile Brachytherapy - organ preservation alternative

Patient Selection Criteria:

• Clinical stage: T1N0 and T2N0 (no clinically palpable lymph nodes)
• Maximal tumour diameter 4cm
• Extension of tumour onto penile shaft is a contra-indication to brachytherapy
• Grade 1, 2 (well to moderately differentiated tumours)
• Grade 3 and bilateral groin node dissection negative for nodal involvement
• Patients must be circumcised
• Good general condition

Staging:

• For T1N0 well differentiated tumours routine CT scan may not be required
• For all others (T1 N0 grade 2, T2N0 any grade) a CT is recommended for nodal staging
• Staging groin dissection recommended for all T2, and T1 Grade 3 tumours

Procedure:

Implant is performed in the OR under general anaesthetic. Volume implant is done using 4-10 17 gauge sterile needles held in place with 2 parallel acrylic templates. Patients remain in hospital for minimum 5 days to receive radiation treatment using the needle implant and HDR technique. Mild analgesia (Acetaminophen or Tylenol #3) and DVT prophylaxis is administered to all patients.

Lymph nodes are managed by surveillance (clinical exam, periodic CT scans) or prophylactic dissection as above.

Outcomes:

Functional organ preservation rate at 2 years is 89% and at 5 years, 85% (Crook at all. Int. J. radiation oncology Biol. Phys. Vol 62, No2.pp460, 2005 ). Surgery is reserved for local failures.

Side effects:

Moist desquamation of the skin/glans penis is expected after the procedure. This heals in 2-3 months. Urethral stenosis rate is 1—15 %. Radiation soft tissue necrosis rate is about 15%. Conservative or hyperbaric oxygen management is appropriate, and surgery reserved for conservative management failure.

Procedure is available at the Vancouver Centre (VC) and at the Center for Southern Interior in Kelowna (CSI).

T1 N1 Stage II and T2 N2 Stage III

1. partial penectomy or radical penectomy
2. therapy for a short period then reassessment at six weeks. At that time all patients should have a sentinel node biopsy. If the biopsy is positive, then bilateral ilioinguinal node dissection should be performed. Patients with positive lymph nodes in the specimen may be considered for pelvic radiotherapy
3. patients whose medical condition does not permit surgery or where the patient does not wish to have surgery, radiotherapy to the pelvis and inguinal nodes is an alternative treatment

T3 N0 Stage III and T4 or N3 or M1 Stage IV

Exenterative surgery in select cases. Palliative radiotherapy and/or chemotherapy.

4. Follow-up

Following the completion of treatment, all patients need to be monitored for potential recurrence of cancer and complications of therapy. This is needed both for management of the individual patient (where early detection would improve outcome), and to permit periodic review and improvement of current treatment policy.

The patient should be seen monthly for one year after treatment of the primary disease to assess the inguinal regions, if these have not been treated initially. Thereafter:

• Year 2 = q 3 months
• Year 3 = q 4 months
• Year 4-5 = q 6 months

Often it is felt appropriate to share follow up with the family doctor (and/or the urologist), in which case it is important for the patient to be clear who is responsible for certain aspects of the disease, e.g. symptom control by the family doctor, with advice from the BC Cancer Agency at the doctor's request.

Notification is requested in the event of any of the following:

1. recurrence at the primary site (particularly in patients with clinically localized disease treated with surgery and/or radiotherapy)
2. at regional or distant sites
3. of therapy especially if acute requiring hospitalization, or chronic and symptomatic
4. with primary cause and whether cancer or treatment contributed

The event, date, and evidence where appropriate should be sent to the Agency chart where it will come to the attention of the oncologist, and will be available for periodic review by the tumour group. This information is requested annually for patients no longer followed at the BC Cancer Agency.