Phase II Study of Photodynamic Therapy With WST-09 in Patients With Recurrent or Persistent Localized Carcinoma of the Prostate Following Radiation Therapy Failure : Effect of the Light Dose and the Number of Fibres
18 Years
N/A
Male
Recurrent or Persistent Localized Carcinoma of the Prostate Following Radiation Therapy Failure
Trial Information
Phase II Study of Photodynamic Therapy With WST-09 in Patients With Recurrent or Persistent Localized Carcinoma of the Prostate Following Radiation Therapy Failure : Effect of the Light Dose and the Number of Fibres
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 cancer is expected. It has been estimated that by the year 2002,
92,000 men over 65 years of age were diagnosed annually in the European community, where
prostate cancer will account for 12% of all new male cancer diagnoses.
Consequently, radiation therapy is used extensively for primary therapy of prostatic
carcinoma. The Management Report of clinically localized prostate cancer by the National
Cancer Institute SEER program indicated that 30% of patients choose radiation therapy as
their first treatment option. However, the ability of radiation therapy to totally and
permanently eradicate prostatic cancer has come under question recently as a result of the
high number of patients who have post radiotherapy elevated prostatic specific antigen (PSA)
determinations (85%), and the high positive post irradiation biopsy rate (31 90%). With high
local recurrence rates possibly influencing death rates, the recurrence of prostate cancer
after potentially curative local therapy is becoming a significant urological problem. As
patients are being treated for prostate cancer at a younger age, a significant number of
them will ultimately fail the primary treatment and will be candidates for safe and
potentially curative salvage therapy.
High complication and morbidity rates associated with current salvage therapies demand new
and improved means for eradicating recurrent local disease. Photodynamic therapy, which
allows the destruction of a tumor by the IV administration of a photosensitizer and the
local application of light, may provide such means. Transperineal interstitial photodynamic
therapy is a minimally invasive procedure to treat selected patients with failed radiation
therapy of prostate cancer. A preliminary phase 1 study using the photosensitizer
meso-tetrahydroxyphenyl chlorine (mTHPC) in 14 patients indicated that PDT could produce
necrosis in prostate involving cancers recurring after radiotherapy, with a low incidence of
complications.
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Inclusion Criteria:
18 years of age or olderAbility 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)
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
John Trachtenberg, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University Health Network, Toronto
Authority:
Canada: Health Canada
Study ID:
HEC/WST03 658 N/WST 2.08
NCT ID:
NCT00308919
Start Date:
April 2004
Completion Date:
November 2005
Related Keywords:
- Recurrent or Persistent Localized Carcinoma of the Prostate Following Radiation Therapy Failure
- Carcinoma
- Prostatic Neoplasms
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