MedTrace Logo

Efficacy,Safety and Quality of Life After TOOKAD® Soluble VTP for Localized Prostate Cancer

NCT01875393 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2016-04-19

No results posted yet for this study

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.

Conditions

Interventions

DRUG

TOOKAD® 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 & Collaborators

  • Steba Biotech S.A.

    lead OTHER

Principal Investigators

  • Jose Arturo Rodriguez Rivera, Dr · Hospital General Tlahuac

  • Mary Lol Ve Mendoza Medina, Dr · Hospital General Tlahuac

  • Luis Zegarra Montes, Professor · Hospital Nacional Cayetano Heredia

  • Ramón Rodriguez, Professor · Pan-American Medical Research Institute (PAMRI) then moved to Consultario del Dr Rodriguez

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2014-12-31
Completion
2015-03-31

Countries

  • Mexico
  • Panama
  • Peru

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01875393 on ClinicalTrials.gov