Status:
COMPLETED
Study of Photodynamic Therapy in Patients With Prostate Cancer Following Radiation Therapy
Lead Sponsor:
STEBA France
Collaborating Sponsors:
University Health Network, Toronto
Conditions:
Recurrent or Persistent Localized Carcinoma of the Prostate Following Radiation Therapy Failure
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
To assess by MR Imaging the lesions induced by WST09-mediated photodynamic therapy (PDT) in patients with recurrent or persistent localized prostate cancer following definitive radiotherapy using diff...
Detailed Description
Prostate cancer is a leading cause of morbidity and mortality in men around the world. Because of the worldwide increase in life expectancy, a dramatic increase in the number of patients with prostate...
Eligibility Criteria
Inclusion
- \- 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
- 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)
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2005
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00308919
Start Date
April 1 2004
End Date
November 1 2005
Last Update
June 22 2010
Active Locations (1)
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1
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G2M9