Study of Photodynamic Therapy in Patients With Prostate Cancer Following Radiation Therapy

• Status: Completed
• Trial end date: 2005-11-01
• Target enrollment: 0
• Participant gender: Male

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 different light doses and multiple illuminating fibres.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: STEBA France
• Collaborator: University Health Network, Toronto

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)