Status:
COMPLETED
Efficacy,Safety and Quality of Life After TOOKAD® Soluble VTP for Localized Prostate Cancer
Lead Sponsor:
Steba Biotech S.A.
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT01875393
Start Date
May 1 2013
End Date
March 1 2015
Last Update
April 19 2016
Active Locations (3)
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1
Hospital General Tlahuac
Mexico City, Mexico, 13278
2
Pan-American Medical Research Institute (PAMRI) then moved to Consultario del Dr Rodriguez
Panama City, Panama
3
Hospital Nacional Cayetano Heredia
San Martín de Porres, Peru