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

This study has been completed.
Information provided by (Responsible Party):
Steba Biotech S.A. Identifier:
First received: June 7, 2013
Last updated: April 17, 2016
Last verified: April 2016
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.

Condition Intervention Phase
Prostate Cancer
Drug: TOOKAD® Soluble
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Steba Biotech S.A.:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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

  • The rate of adverse events. [ Time Frame: Screening-Month 12 ]
    Adverse event reporting.

  • 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

  • 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.

Enrollment: 81
Study Start Date: May 2013
Study Completion Date: March 2015
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: WST11

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01875393

Hospital General Tlahuac
Mexico DF, Mexico, 13278
Pan-American Medical Research Institute (PAMRI) then moved to Consultario del Dr Rodriguez
Panama city, Panama
Hospital Nacional Cayetano Heredia
San Martin de Porres, Peru
Sponsors and Collaborators
Steba Biotech S.A.
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
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Steba Biotech S.A. Identifier: NCT01875393     History of Changes
Other Study ID Numbers: CLIN1201 PCM304
Study First Received: June 7, 2013
Last Updated: April 17, 2016
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: The data are available in case report form for each patient

Keywords provided by Steba Biotech S.A.:
Prostatic Disease
Genital Neoplasm,male
Urogenital neoplasm
Genital disease,male
Male urogenital disease
Neoplasms by site
Prostatic neoplasm

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases processed this record on April 28, 2017