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Trial record 10 of 14 for:    photodynamic | Prostate Cancer

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01875393
Recruitment Status : Completed
First Posted : June 11, 2013
Last Update Posted : April 19, 2016
Information provided by (Responsible Party):
Steba Biotech S.A.

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: TOOKAD® Soluble Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : May 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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 Name: WST11

Primary Outcome Measures :
  1. 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 :
  1. 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

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

  3. 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

  4. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01875393

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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.
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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 automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Steba Biotech S.A. Identifier: NCT01875393    
Other Study ID Numbers: CLIN1201 PCM304
First Posted: June 11, 2013    Key Record Dates
Last Update Posted: April 19, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
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:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases