Study of Photodynamic Therapy in Patients With Prostate Cancer Following Radiation Therapy
Recurrent or Persistent Localized Carcinoma of the Prostate Following Radiation Therapy Failure
About this trial
This is an interventional treatment trial for Recurrent or Persistent Localized Carcinoma of the Prostate Following Radiation Therapy Failure
Eligibility Criteria
- Inclusion Criteria: 18 years of age or older Ability to understand the patient's information sheet and to give written informed consent Histologic proof of adenocarcinoma of the prostate 12 months or longer following definitive radiotherapy Disease confined to the prostate (stage T1-N0 or X-M0 or X or T2-N0 or X -M0 or X) without evidence of regional and/or distant disease Recent (within 90 days) CT scan of the abdomen and pelvis and radionucleotide bone scan or equivalent radiographic imaging confirming that no disease is outside of the prostate Recent (within 3 months) cystoscopy if clinically warranted Serum prostatic specific antigen (PSA) equal to or less than 20 ng/mL Serum PSA showing two consecutive increases at least 2 weeks apart Life expectancy more than 5 years, based on co-morbidity not related to prostate cancer Ability to comply with the requirements of the study - Exclusion Criteria: Patients who are currently receiving any hormone treatment for prostatic carcinoma or for any other cancer, or have done so within the last 6 months. Patients who have received or are receiving chemotherapy for prostatic carcinoma or for any other cancer Patients who are currently receiving any photosensitizing medications (e.g. tetracyclines, sulfonamides, phenothiazines, sulfonylurea hypoglycemic agents, thiazide diuretics and griseofulvin) Patients who have received a TURP (trans-urethral resection of the prostate) Patients whose radiation therapy caused extensive cystitis and/or proctitis Any condition, or history of illness or surgery that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the patient (e.g. significant cardiovascular conditions) History of non compliance with medical therapy and medical recommendations or an unwillingness or inability to complete patient self-administered questionnaires Participation in a clinical study or receipt of an investigational treatment within the past 90 days A history of porphyria A history of significant allergies, particularly to Cremophor® and Benadryl® A history of sun hypersensitivity or photosensitive dermatitis Renal disorders (blood creatinine > 1.5 x ULN) Hepatic disorders (transaminases > ULN, bilirubin> ULN) Hematological disorders: (White cells < 2500/mm3, neutrophil< 1500/mm3, platelets <140,000/mm3, Hb < 8 g/dl)
Sites / Locations
- Princess Margaret Hospital
Arms of the Study
Arm 1
Experimental
WST 09
Treatment with WST09 Vascular Photodynamic therapy