Efficacy,Safety and Quality of Life After TOOKAD® Soluble Vascular Targeted Photodynamic Therapy for Localized Prostate Cancer (PCM304)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Steba Biotech S.A.
ClinicalTrials.gov Identifier:
NCT01875393
First received: June 7, 2013
Last updated: June 27, 2014
Last verified: June 2014
  Purpose

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: Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Adverse event reporting.

  • The overall cancer burden in the prostate determined by biopsy as compared to baseline. [ Time Frame: Month 12 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Severe prostate cancer related events: cancer extension to T3, metastasis or prostate cancer-related death.


Enrollment: 81
Study Start Date: May 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: July 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  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 ClinicalTrials.gov identifier: NCT01875393

Locations
Mexico
Hospital Dr. Ajusco Medio
Del Tlalpan, Mexico, 14250
Hospital General Tlahuac
Mexico DF, Mexico, 13278
Panama
Pan-American Medical Research Institute (PAMRI)
Panama city, Panama
Peru
Hospital Nacional Cayetano Heredia
San Martin de Porres, Peru
Sponsors and Collaborators
Steba Biotech S.A.
Investigators
Principal Investigator: Jose Arturo Rodriguez Rivera, Dr Hospital General Tlahuac
Principal Investigator: Jose Arturo Ramirez, Dr Hospital Dr. Ajusco Medio
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)
  More Information

No publications provided

Responsible Party: Steba Biotech S.A.
ClinicalTrials.gov Identifier: NCT01875393     History of Changes
Other Study ID Numbers: CLIN1201 PCM304
Study First Received: June 7, 2013
Last Updated: June 27, 2014
Health Authority: Mexico: Federal Commission for Sanitary Risks Protection
Peru: Instituto Nacional de Salud
Panama: Ministry of Health

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

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on July 29, 2014