Cancer of the Prostate
Conditions
Brief summary
This is an open observational extended follow-up study of patients originally randomized into TOOKAD® Soluble VTP therapy or active surveillance (control group). Additional 60-month follow-up study
Detailed description
This is an open observational extended follow-up study of patients originally randomized into TOOKAD® Soluble VTP therapy or active surveillance (control group). No intervention or further intervention with TOOKAD® Soluble is mandated in this additional 60-month follow-up study where patients in the original TOOKAD® Soluble group and active surveillance (control) group are both managed by their physician as appropriate to their condition using any treatment available following a 'local standard of care' principle from the end of the trial (M24) up to the end of follow-up (M84). Management decisions are entirely left to clinicians and their patients in this pragmatic extension of the trial (no criteria imposed) where standard of care that reflects clinical practice within each centre is applied. All patients originally randomised in study CLIN1001 PCM301, whether allocated to the TOOKAD® Soluble VTP arm (n=206) or Active surveillance arm (n=207 and who did not withdraw their consent will be included in this extension study. This extension study consists of 2 different follow-up: * a follow-up of patients via investigators * and a follow-up via interviews directly with patients
Interventions
OTHERno intervention (post study follow up)
No intervention (post study follow up)
Sponsors
International Drug Development Institute
ICON plc
Steba Biotech S.A.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Inclusion criteria
* All subjects originally randomized in study CLIN1001 PCM301 are included in this follow-up study. As a reminder, they all met the following criteria at entry (from the original protocol): 1. Low risk prostate cancer diagnosed using one trans-rectal 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
* As a reminder, all subjects originally randomized did not met the following criteria at entry (from the original protocol): 1. Unwillingness to accept randomization 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 the study tasks. Subject in custody and 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 | Description |
|---|---|---|
| Disease progression | Over the 5 years of follow up | Progression of disease from low risk prostate cancer to moderate or higher risk prostate cancer in men initially randomized to TOOKAD® Soluble VTP compared to men originally randomized on active surveillance. |
| Other prostate cancer therapy | Over the 5 years of follow up | Use of other prostate cancer therapy: radical therapy (surgery, radiotherapy, cryotherapy, ultrasound therapy), hormonal therapy or chemotherapy or any therapy indicated for the treatment of prostate cancer in the countries of the study. |
| Prostate cancer-related death. | Over the 5 years of follow up | Any death related to Prostate cancer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Urinary incontinence | Over the 5 years of follow up | The description of incontinence in terms of mean, median, SD, inter-quartile ranges, min-max |
| Erectile dysfunction | Over the 5 years of follow up | The description of erectile dysfunction in terms of mean, median, SD, inter-quartile ranges, min-max |
| Absence of cancer | Over the 5 years of follow up | The proportion of absence of cancer at biopsy (when available) |
| Prostate cancer complication | Over the 5 years of follow up | The rate of severe prostate cancer related events: cancer extension to T3, metastasis and prostate cancer related death |
| Patients Questionnaires Quality of life | Over the 5 years of follow up | Overal Quality of Life will be recorded for potential utility and descriptives studies |
| Urethral stenosis | Over the 5 years of follow up | The rate of urethral stenosis |
| Radical therapy | Over the 5 years of follow up | The rate of prostate cancer radical therapy; |
| Cancer burden | Over the 5 years of follow up | The total cancer burden in the prostate |
Countries
Finland, France, Germany, Italy, Netherlands, Spain, Sweden, United Kingdom
Outcome results
None listed