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Study of Erectile Dysfunction, Urinary Incontinence and Related QoL After TOOKAD® VTP for Low Risk Prostate Cancer

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ClinicalTrials.gov Identifier: NCT03849365
Recruitment Status : Recruiting
First Posted : February 21, 2019
Last Update Posted : March 1, 2019
Sponsor:
Collaborators:
International Drug Development Institute
PrimeVigilance LTD
Information provided by (Responsible Party):
Steba Biotech S.A.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Low Risk Prostate Cancer Drug: TOOKAD VTP Phase 4

Detailed Description:

This is a multiple center, single-arm, open-label, 12-month follow-up phase IV pragmatic clinical trial. Men with unilateral prostate cancer meeting eligibility criteria for the drug (as per the EEA Marketing Authorisation) will receive TOOKAD® VTP under general anesthesia. The primary objective is 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. Prior to the TOOKAD® VTP, patients will undergo routine ultrasound examination in the operating room for morphometric description of the prostate and to facilitate accurate treatment guidance for the treatment with TOOKAD® VTP. Treatment will then be applied to the prostate gland as a hemi-ablation procedure designed to destroy the lobe of the prostate gland that contains the cancer. Afterwards, patients will be followed for 12 months with clinical evaluation, data collection on erectile and urinary functions at 1, 2, 3 6 and 12 months, using the Expanded Prostate Cancer Index Composite (EPIC), International Index of Erectile Function (IIEF) and International Prostate Score Symptom (IPSS) questionnaires on Quality Of Life (QOL) and Prostate Specific Antigen (PSA) testing at 3, 6 and 12 months.

The clinical follow-up of patients will follow local standard of care processes, based on recommendations in the European Summary of Product Characteristics (SmPC).

This study is a phase IV pragmatic trial using optimal dose of TOOKAD® and optimal light-energy level conditions that were determined during development and approved by the European Commission.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Multiple center, single-arm, open-label, 12-month follow-up phase IV pragmatic clinical trial.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : January 21, 2019
Estimated Primary Completion Date : January 2, 2021
Estimated Study Completion Date : January 2, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TOOKAD VTP
TOOKAD is administered as part of focal VTP under general anaesthetic. TOOKAD® VTP consists of the combination of a single, 10-minute IV infusion of TOOKAD® at the dose of 3.66 mg/kg, followed by the illumination of the zone to be treated with a 753-nm laser light delivered through transperineal interstitial optical fibers at a power of 150 mW/cm and light energy of 200 J/cm applied over 22 minutes and 15 seconds.
Drug: TOOKAD VTP
TOOKAD® VTP consists of the combination of a single, 10-minute IV infusion of TOOKAD® at the dose of 3.66 mg/kg, followed by the illumination of the zone to be treated with a 753-nm laser light delivered through transperineal interstitial optical fibers at a power of 150 mW/cm and light energy of 200 J/cm applied over 22 minutes and 15 seconds.




Primary Outcome Measures :
  1. Cumulated time with toxicity (duration) [ Time Frame: 12 months ]
    Time to onset, average duration and average time to resolution (either Erectile Dysfunction (ED) and/or Urinary Incontinence(UI)) during the 12 months following VTP of ED with severity grade 2 or over and/or UI of severity grade 2 or over, as assessed using the EPIC instrument

  2. Cumulated time with toxicity (prevalence) [ Time Frame: 12 months ]
    Prevalence at different points in time (either ED and/or UI) during the 12 months following VTP of ED with severity grade 2 or over and/or UI of severity grade 2 or over, as assessed using the EPIC instrument.

  3. Cumulated time with toxicity (area under the curve) [ Time Frame: 12 months ]
    Area under the curve with the presence of ED with severity grade 2 or over and/or UI of severity grade 2 or over, as assessed using the EPIC instrument


Secondary Outcome Measures :
  1. Time with erectile dysfunction (duration) [ Time Frame: 12 months ]
    Time to onset, duration, time to resolution of erectile dysfunction grade 2 or above, as assessed using the EPIC instrument

  2. Time with erectile dysfunction (prevalence) [ Time Frame: 12 months ]
    Prevalence at different points in time of erectile dysfunction grade 2 or above, as assessed using the EPIC instrument

  3. Time with erectile dysfunction (Area under the curve) [ Time Frame: 12 months ]
    Area under the curve with the presence of erectile dysfunction grade 2 or above, as assessed using the EPIC instrument

  4. Time with urinary incontinence (duration) [ Time Frame: 12 months ]
    Time to onset, duration, time to resolution of urinary Incontinence grade 2 or above, as assessed using the EPIC instrument,

  5. Time with urinary incontinence (prevalence) [ Time Frame: 12 months ]
    Prevalence at different points in time of urinary Incontinence grade 2 or above, as assessed using the EPIC instrument.

  6. Time with urinary incontinence (Area under the curve) [ Time Frame: 12 months ]
    Area under the curve with the presence of urinary Incontinence grade 2 or above, as assessed using the EPIC instrument.

  7. Correspondence between results of EPIC and IIEF instruments [ Time Frame: 12 months ]
    Average variation on urinary symptoms (UI) using the EPIC and IPSS instruments, erectile functions (ED) using the EPIC and IIEF instruments, and bowel function using the EPIC instrument, prior to treatment beginning and then at 1, 2, 3, 6 and 12 months after completing treatment: absolute scores and changes as compared to baseline (absolute difference of means and proportion change)

  8. PSA density [ Time Frame: 12 months ]
    Average changes from baseline in PSA density at month 12

  9. Rate of Adverse Events [ Time Frame: 12 months ]
    Rate of adverse events (AE) of TOOKAD® VTP treatment : all AE, important AE identified in Risk Management Plan (RMP) and suspected AE listed in RMP.

  10. Time to resolution of Adverse events [ Time Frame: 12 months ]
    Time to resolution of adverse events for each adverse event reported

  11. Additional prostate cancer treatments [ Time Frame: 12 months ]
    Rate of additional treatment as decided by local practice, such as radical therapy (surgical removal of the prostate gland, radiation treatment to the prostate gland) or other intervention therapy to the ipsilateral and/or contralateral lobe, use of hormone or chemotherapies.

  12. Extension of prostate cancer [ Time Frame: 12 months ]
    Rate of reported extension of prostate cancer based on locally decided investigations (such as clinical examination, biopsy, Magnetic resonance Imaging (MRI), other).



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
Criteria

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 :

  • 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.

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 ClinicalTrials.gov identifier (NCT number): NCT03849365


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

Locations
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France
Centre Hospitalier Universitaire (CHU) Recruiting
Angers, France
Contact: Abdel-Rahmène AZZOUZI, Professor    +33 2 41 35 35 18    arazzouzi@chu-angers.fr   
Principal Investigator: Abdel-Rahmène, AZZOUZI, Professor         
Sponsors and Collaborators
Steba Biotech S.A.
International Drug Development Institute
PrimeVigilance LTD
Investigators
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Principal Investigator: Abdel-Rahmène AZZOUZI, Professor Centre Hospitalier Universitaire (CHU) ANGERS

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Responsible Party: Steba Biotech S.A.
ClinicalTrials.gov Identifier: NCT03849365     History of Changes
Other Study ID Numbers: CLIN1802 PCM404
2018-003228-35 ( EudraCT Number )
First Posted: February 21, 2019    Key Record Dates
Last Update Posted: March 1, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Erectile Dysfunction
Prostatic Neoplasms
Urinary Incontinence
Enuresis
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological