Clinical trial NCT00312442: Phase II/III Study of WST09 in Prostate Cancer After Radiation Therapy
Official title: Study of Photodynamic Therapy With WST09 in Patients With Recurrent or Persistent Localized Carcinoma of the Prostate Following Radiation Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Prostate Cancer
Keywords: Prostate cancer after radiation therapy
Lead sponsor: STEBA France
Sponsor class: INDUSTRY
First posted: 2006-04-10
Enrollment: 16
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this clinical trial is to evaluate the efficacy and safety of the WST09-mediated vascular-targeted photodynamic therapy (VTP) in patients with localized prostate cancer recurrent after external radiation therapy or temporary (High Dose Rate, or HDR) brachytherapy.

Detailed description: This is a multicentre, open labelled, phase II/III, 6-month clinical trial with an additional follow-up at Month 12, aiming to determine the efficacy and tolerability of the WST09-mediated VTP treatment. This treatment consists of an I.V. infusion of WST09 (2 mg/kg), in combination with per-cutaneous interstitial illumination using laser light (wavelength at 763nm) delivered through optical fibres positioned through the perineum in the prostatic lobes.

Patients who are eligible to participate in the study must have a clinically diagnosed positive biopsy of the prostate (up to stage T2b-N0-M0) diagnosed after external radiotherapy or temporary brachytherapy (no seeds), and present with increasing PSA levels on three consecutive occasions (at least 3 months apart) post-radiation treatment.

Eligibility criteria: Inclusion Criteria:

Histologically proven localized prostate cancer after receiving external radiation therapy;

Exclusion Criteria:

Patients unwilling or unable to give informed consent; Patients who received or are receiving chemotherapy; Patients previously treated with HIFU, cryotherapy, other salvage treatments, or with a trans-urethral resection of the prostate (TURP); Patients whose previous radiation therapy caused extensive cystitis and/or proctitis.

Patients suspected of Disseminated Intravascular Coagulation (DIC). Patients with prior history of coronary artery disease, angina pectoris, myocardial infarction, coronary angioplasty or coronary artery bypass graft, severe valvulopathy, cardiac failure, artrial fibrillation and / or sustained arrhythmia.

Patients whose cardiac status does not allow general anesthesia. Patients with history of thromboses or thrombo-embolisms. Patients with history of stroke or transient ischemic attack.

Primary outcomes:
measure: Prostate biopsy results at Month 6 after treatment.
timeFrame: 6 months
Secondary outcomes:
measure: Percentage of positive cores in the biopsies prior to and 6 months after the WST09-mediated VTP.
timeFrame: 6 months
measure: PSA levels taken periodically for 1 year after the procedure
timeFrame: Month 1,3,6 and 1 year
measure: Hypoperfusion according to MRI at Week 1 after the procedure.
timeFrame: 1 week and Month 6
measure: Calculated PSA velocity before and after WST09-mediated VTP.
timeFrame: Month 1,3,6 and 1 year
measure: Nadir of the PSA after the WST09-mediated VTP compared with the nadir of PSA after radiation therapy
timeFrame: Month 1,3,6 and 1 year
measure: To assess the safety and tolerability of WST09-mediated VTP treatment in this patient population
timeFrame: Day1,Day 7, Month1,3,6,and 12
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Princess Margaret Hospital
name: John Trachtenberg, MD FRCS(C)
role: PRINCIPAL_INVESTIGATOR
References: