Prostate Cancer
Conditions
Keywords
Prostate cancer after radiation therapy
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.
Interventions
DRUGTreatment with WST09 Vascular Photodynamic therapy
Sponsors
STEBA France
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Prostate biopsy results at Month 6 after treatment. | 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PSA levels taken periodically for 1 year after the procedure | Month 1,3,6 and 1 year | — |
| Hypoperfusion according to MRI at Week 1 after the procedure. | 1 week and Month 6 | — |
| Percentage of positive cores in the biopsies prior to and 6 months after the WST09-mediated VTP. | 6 months | — |
| Nadir of the PSA after the WST09-mediated VTP compared with the nadir of PSA after radiation therapy | Month 1,3,6 and 1 year | — |
| To assess the safety and tolerability of WST09-mediated VTP treatment in this patient population | Day1,Day 7, Month1,3,6,and 12 | The evaluation of safety will be based on reported adverse events, changes in vital signs and laboratory tests from the Treatment Visit until the study is completed. |
| Calculated PSA velocity before and after WST09-mediated VTP. | Month 1,3,6 and 1 year | — |
Countries
Canada
Outcome results
None listed