Prostate Cancer
Conditions
Keywords
Prostatic Disease, Genital Neoplasm,male, Urogenital neoplasm, Genital disease,male, Male urogenital disease, Neoplasms, Neoplasms by site, Prostatic neoplasm, Carcinoma
Brief summary
The aim of this study is to confirm the Efficacy,the Safety and the Quality of Life after TOOKAD® Soluble VTP in localized prostate cancer patients.
Detailed description
The study is designed as a multicenter, single-arm, open label, 12 months follow-up clinical trial. Men with localized prostate cancer will be treated with TOOKAD® Soluble VTP under general anesthesia. Patients will be followed-up for 12 months with patient questionnaires on QoL, erectile and urinary functions, clinical evaluation with study visits at 1, 3, 6 and 12 months , Prostate Specific Antigen(PSA) testing at 3, 6 and 12 months. In addition, they will have biopsy at 6 months (± 2) and 12 months.
Interventions
DRUGTOOKAD® Soluble
The VTP procedure will consist of a single, 10 minute infusion of 4mg/kg TOOKAD® Soluble. The drug will be activated by laser light at 753nm, with a fixed energy of 200Joules/cm, and a fixed power of 150mWatts/cm, delivered through transperineal interstitial optical fibers. The needles are positioned in the prostate under ultra sound image guidance.
Sponsors
Steba Biotech S.A.
Study design
Allocation
NA
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 carcinoma diagnosed using prostate biopsy showing: * Gleason 3+3 prostate * Gleason 3+4 prostate adenocarcinoma is acceptable provided it is not present in more than 2 cores and no more than 50% cancer in any core. * Clinical stage up to cT2a - N0/Nx - M0/Mx. * Serum prostate-specific antigen (PSA) ˂ 20ng/ml * Prostate volume ≥ 25 cc and ≤ 70 cc. * Male subjects aged 18 years or older. * Signed Informed Consent Form by the patient.
Exclusion criteria
* Unwillingness to accept the treatment. * Any prior or current treatment for prostate cancer, including surgery, radiation therapy (external or brachytherapy)or chemotherapy. * Any surgical intervention for benign prostatic hypertrophy. * Any condition or history of illness or surgery that may pose an additional risk to men undergoing the VTP procedure. * Life expectancy less than 10 years. * Participation in another clinical study involving an investigational product within 1 month before study entry. * Subject unable to understand the patient's informed consent document, to give consent voluntarily or to complete the study tasks, especially unable to understand and fulfill the health-related QoL questionnaire. * Subject in custody and or in residence in a nursing home or rehabilitation facility. * Any condition or history of active rectal inflammatory bowel disease or other factors which may increase the risk of fistula formation; * Any hormonal manipulation (excluding 5-alpha-reductase inhibitors) that alters androgen production or use of androgen supplements within the previous 6 months; * Any history of urethral stricture disease; * Any history of acute urinary retention within 6 months of study entry
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To confirm that a significant proportion of patients will be prostate cancer free on the biopsy. | Month 12 | Number of patients with a negative biopsy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in urinary and erectile functions and their potential impact on quality of life using International Prostate Symptom Score (IPSS), International Index of Erectile Function (IIEF) and the General quality of life (EQ5D) questionnaires. | Screening, 1, 3, 6 and 12 months after completing treatment | Patients' reported outcome measures (PROMs) impairment: urinary symptoms using IPSS and erectile functions using IIEF. Quality of life using EQ5D will also be described |
| The rate of adverse events. | Screening-Month 12 | Adverse event reporting. |
| The overall cancer burden in the prostate determined by biopsy as compared to baseline. | Month 12 | Total length of cancer present in all cores taken in any given biopsy session |
| The rate of severe prostate cancer related events: cancer extension to T3, metastasis and prostate cancer related death | Screening-Month 12 | Severe prostate cancer related events: cancer extension to T3, metastasis or prostate cancer-related death. |
Countries
Mexico, Panama, Peru
Outcome results
None listed