BCG + MMC: Adding Mitomycin C to BCG in High-risk, Non-muscle-invasive Bladder Cancer

Inclusion criteria

• Males or females with confirmed high grade pTa or stage pT1 (any grade) non-muscle invasive bladder cancer on initial or re-resection histology (concurrent carcinoma in situ is allowed).
• Age ≥ 18 yrs
• No macroscopically visible disease at cystoscopy within 8 weeks prior to randomisation. This may either be the initial TURBT at which the primary tumour was completely resected, or a planned second cystoscopy and/ or re-resection done within 8 weeks of the initial TURBT.
• ECOG Performance Status of 0-2
• Adequate bone marrow, renal and liver function confirmed by pre-randomisation blood tests.
• Study treatment both planned and able to start within 4 weeks of randomisation
• Is willing to complete HRQL questionnaires or is unable to complete them because of literacy, insufficient English or limited vision
• Willing and able to comply with all study requirements, including treatment, timing and/or nature of all required assessments
• Signed, written informed consent

Exclusion criteria

• Contraindications or hypersensitivity to investigational products, BCG and MM
• Prior treatment with any other intravesical agent including BCG or MM (excludes single doses given post TURBT)
• Current or past transitional cell carcinoma (TCC) of the upper urinary tract
• Prior muscle-invasive (stage T2 or higher) transitional-cell carcinoma of the bladder
• Bladder dysfunction precluding intravesical therapy e.g. Severe urinary incontinence or overactive or spastic bladder
• Life expectancy < 3 months
• Congenital or acquired immune deficiencies, whether due to a concurrent disease (e.g. acquired immune deficiency syndrome (AIDS), leukaemia, lymphoma) or immunosuppressive therapy (e.g. corticosteroids), or cancer therapy (cytotoxic drugs, radiation)
• Prior radiotherapy of the pelvis
• Prior or current treatment with radiotherapy-response or biological-response modifiers
• Clinical evidence of existing active tuberculosis
• History of another malignancy within 5 years prior to registration. Patients with non-melanomatous carcinoma of the skin are eligible for this study.
• Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the protocol.
• Pregnancy, lactation, or inadequate contraception. Women must be post menopausal, infertile, or use a reliable means of contraception. Women of childbearing potential must have a negative pregnancy test done within 7 days prior to registration. Men must have been surgically sterilised or use a (double if required) barrier method of contraception.