Efficacy,Safety and Quality of Life After TOOKAD® Soluble VTP for Localized Prostate Cancer (PCM304)

April 17, 2016 updated by: Steba Biotech S.A.

Study of the Efficacy,Safety and Quality of Life After TOOKAD® Soluble Vascular Targeted Photodynamic Therapy (VTP) for Minimally Invasive Treatment of Localized Prostate Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

81

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Mexico DF, Mexico, 13278
        • Hospital General Tlahuac
  • Panama
      • Panama city, Panama
        • Pan-American Medical Research Institute (PAMRI) then moved to Consultario del Dr Rodriguez
  • Peru
      • San Martin de Porres, Peru
        • Hospital Nacional Cayetano Heredia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TOOKAD® Soluble
TOOKAD® Soluble, lyophilized formulation,given at a dose of 4 mg/kg.
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.
Other Names:
  • WST11

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To confirm that a significant proportion of patients will be prostate cancer free on the biopsy.
Time Frame: Month 12
Number of patients with a negative biopsy.
Month 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 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
Screening, 1, 3, 6 and 12 months after completing treatment
The rate of adverse events.
Time Frame: Screening-Month 12
Adverse event reporting.
Screening-Month 12
The overall cancer burden in the prostate determined by biopsy as compared to baseline.
Time Frame: Month 12
Total length of cancer present in all cores taken in any given biopsy session
Month 12
The rate of severe prostate cancer related events: cancer extension to T3, metastasis and prostate cancer related death
Time Frame: Screening-Month 12
Severe prostate cancer related events: cancer extension to T3, metastasis or prostate cancer-related death.
Screening-Month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Steba Biotech S.A.

Investigators

  • Principal Investigator: Jose Arturo Rodriguez Rivera, Dr, Hospital General Tlahuac
  • Principal Investigator: Mary Lol Ve Mendoza Medina, Dr, Hospital General Tlahuac
  • Principal Investigator: Luis Zegarra Montes, Professor, Hospital Nacional Cayetano Heredia
  • Principal Investigator: Ramón Rodriguez, Professor, Pan-American Medical Research Institute (PAMRI) then moved to Consultario del Dr Rodriguez

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

June 7, 2013

First Submitted That Met QC Criteria

June 7, 2013

First Posted (Estimate)

June 11, 2013

Study Record Updates

Last Update Posted (Estimate)

April 19, 2016

Last Update Submitted That Met QC Criteria

April 17, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLIN1201 PCM304

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

The data are available in case report form for each patient

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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