Study of Erectile Dysfunction, Urinary Incontinence and Related Quality of Life After TOOKAD® Vascular Targeted Photodynamic Therapy (VTP) for Minimally Invasive Treatment of Unilateral Low Risk Prostate Cancer

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Study of Erectile Dysfunction, Urinary Incontinence and Related Quality of Life After TOOKAD® Vascular Targeted Photodynamic Therapy (VTP) for Minimally Invasive Treatment of Unilateral Low Risk Prostate Cancer

Condition: Low Risk Prostate Cancer

Intervention:

  • Drug: TOOKAD VTP

Purpose: Multiple center, single-arm, open-label, 12-month follow-up phase IV pragmatic clinical trial in men with unilateral prostate cancer meeting eligibility criteria for the drug (as per the European Economic Area (EEA) Marketing Authorisation) to assess the occurrence and dynamics of the time with toxicities (urinary incontinence Grade 2 and over and/or erectile dysfunction Grade 2 and over) in patients 12 months following TOOKAD® VTP.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03849365

Sponsor: Steba Biotech S.A.

Primary Outcome Measures:

  • Measure: Cumulated time with toxicity (duration)
  • Time Frame: 12 months
  • Safety Issue:
  • Measure: Cumulated time with toxicity (prevalence)
  • Time Frame: 12 months
  • Safety Issue:
  • Measure: Cumulated time with toxicity (area under the curve)
  • Time Frame: 12 months
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Time with erectile dysfunction (duration)
  • Time Frame: 12 months
  • Safety Issue:
  • Measure: Time with erectile dysfunction (prevalence)
  • Time Frame: 12 months
  • Safety Issue:
  • Measure: Time with erectile dysfunction (Area under the curve)
  • Time Frame: 12 months
  • Safety Issue:
  • Measure: Time with urinary incontinence (duration)
  • Time Frame: 12 months
  • Safety Issue:
  • Measure: Time with urinary incontinence (prevalence)
  • Time Frame: 12 months
  • Safety Issue:
  • Measure: Time with urinary incontinence (Area under the curve)
  • Time Frame: 12 months
  • Safety Issue:
  • Measure: Correspondence between results of EPIC and IIEF instruments
  • Time Frame: 12 months
  • Safety Issue:
  • Measure: PSA density
  • Time Frame: 12 months
  • Safety Issue:
  • Measure: Rate of Adverse Events
  • Time Frame: 12 months
  • Safety Issue:
  • Measure: Time to resolution of Adverse events
  • Time Frame: 12 months
  • Safety Issue:
  • Measure: Additional prostate cancer treatments
  • Time Frame: 12 months
  • Safety Issue:
  • Measure: Extension of prostate cancer
  • Time Frame: 12 months
  • Safety Issue:

Estimated Enrollment: 200

Study Start Date: January 21, 2019

Phase: Phase 4

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  • Men over 18 years of age with a life expectancy ≥ 10 years -.Unilateral adenocarcinoma of the prostate accurately located and confirmed as unilateral using high resolution biopsy strategies based on current best practice, such as multi- parametric MRI based strategies or template-based biopsy procedures.
  • Clinical stage T1c or T2a,
  • Gleason Score ≤ 6, based on high-resolution biopsy strategies
  • 3 positive cancer cores with a maximum cancer core length of 5 mm in any one core or 1 -2 positive cancer cores with ≥ 50 % cancer involvement in any one core or a PSA density ≥ 0.15 ng/mL/cm3.
  • PSA ≤ 10 ng/mL
  • If the patient is sexually active with women who are capable of getting pregnant, he and/or his partner should use an effective form of birth control to prevent getting pregnant during a period of 90 days after the VTP procedure.
  • Signed Informed Consent Form Exclusion Criteria: GENERAL

Exclusion Criteria:

  • GENERAL EXCLUSION CRITERIA :
  • Unwillingness to accept the treatment;
  • Any previous prostatic interventions where the internal urinary sphincter may have been damaged, including trans-urethral resection of the prostate (TURP) for benign prostatic hypertrophy.
  • Participation in another clinical study involving an investigational product within 1 month before study entry;
  • Inability to understand the informed consent document, to give consent voluntarily or to complete the study tasks, especially inability to understand and fulfill the health-related QOL questionnaire;
  • Subjects in custody and or residing in a nursing home or rehabilitation facility;
  • Biopsy proven locally advanced or metastatic prostate cancer. SURGERY AND OTHER TREATMENT-RELATED CONDITIONS OF EXCLUSION
  • Any condition or history of illness or surgery that in the opinion of the investigator might affect the conduct and results of the study or pose additional risks to the subject or any medical condition that precludes the administration of a general anaesthetic or invasive procedures.
  • Hypersensitivity to the active substance or to the excipient (mannitol)
  • Current or prior treatment for prostate cancer.
  • Patients who have been diagnosed with cholestasis.
  • Current exacerbation of rectal inflammatory bowel disease.
  • Anticoagulant medicinal products and those that decrease platelet aggregation (e.g. acetylsalicylic acid) should be stopped at least 10 days before the procedure with TOOKAD. Medicinal products that prevent or reduce platelet aggregation should not be started for at least 3 days after the procedure.

Contact:

  • Abdel-Rahmène AZZOUZI, Professor
  • arazzouzi@chu-angers.fr
  • +33 2 41 35 35 18

Location:

  • Centre Hospitalier Universitaire (CHU)
  • Angers France

View trial on ClinicalTrials.gov

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