prostate cancer
Conditions
Interventions
In order to activate the treatment, patients must undergo Vascular Targeted
Photodynamic therapy (VTP). Subjects will be placed in the lithotomy position
and will remain in this position throughout
Sponsors
Steba Biotech SA
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1) Low risk prostate cancer diagnosed using one transrectal ultrasound guided biopsy (TRUS) using from 10 to 24 cores, within 12 months of enrolment, and showing the following:;• Gleason 3 + 3 prostate adenocarcinoma as a maximum,;• Two (2) to three (3) cores positive for cancer. Patients with only one positive core can be included provided they have at least 3 mm of cancer core length.;• A maximum cancer core length of 5 mm in any core;;2) Cancer clinical stage up to T2a (pathological or radiological up to T2c disease permitted);;3) Serum prostate specific antigen (PSA) of 10 ng/mL or less;;4) Prostate volume equal or greater than 25 cc and less than 70 cc;;5) Male subjects aged 18 years or older.
Exclusion criteria
Exclusion criteria: 1) Unwillingness to accept randomisation to either of the two arms of the study. 2) Any prior or current treatment for prostate cancer, including surgery, radiation therapy (external or brachytherapy) or chemotherapy. 3) Any surgical intervention for benign prostatic hypertrophy. 4) Life expectancy less than 10 years. 5) Any condition or history of illness or surgery that may pose an additional risk to men undergoing the VTP procedure. 6) Participation in another clinical study or recipient of an investigational product within 1 month of study entry. 7) Subject unable to understand the patient's information document, to give consent or complete study tasks. Subject in custody or in residence in a nursing home or rehabilitation facility. 8) Contra-indication to MRI (e.g., pacemaker, history of allergic reaction to gadolinium), or factors excluding accurate reading of pelvic MRI (e.g., hip prosthesis).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Co-primary endpoint 'A' Absence of any histological result definitely positive for cancer. Co-primary endpoint 'B' Failure of treatment due to progression of cancer from low to moderate or higher risk over the 24 month followup. Moderate or higher risk is defined as the observation of: • More than 3 cores positive for cancer when considering all histological examination available during follow-up of study; • or any Gleason primary or secondary pattern 4 or more; • or at least one cancer core length greater than 5 mm; • or PSA>10ng/mL in 3 consecutive measures; • or any T3 prostate cancer; • or any metastasis; • or any prostate cancer related death. Histological changes are assessed at 12 and 24 months using from 10 to 24 cores TRUS biopsies, with the same number and distribution of core samples per zone used for the initial biopsy at study entry or 1 core per 2 cc of tissue in case of significant prostate shrinkage, or any other pathology result obtained during the study planned or not. The follow-up is done up to loss to follow-up, early study termination or 24 months after randomisation, whatever the treatment events occurring (drop-out, radical treatment). A panel blinded to the exposure status reviews the histological reports of all patients, whether reported positive or negative for cancer, and all the PSA data. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Notification of initiation of radical therapy • Total number of cores positive for cancer • Patients* reported outcome measures (PROMs) impairment: urinary symptoms, erectile functions • Adverse event reporting • Severe prostate cancer related events: cancer extension to T3, metastasis or prostate cancer-related death Quality of life will also be described. | — |
Countries
Netherlands
Outcome results
None listed