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

NCT03849365 | Terminated Phase 4

• 2 other identifiers: CLIN1802 PCM4042018-003228-35
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Risk Prostate Cancer

Outcome Measures

Primary Outcomes (3)

• Cumulated time with toxicity (duration)

  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

  12 months

• Cumulated time with toxicity (prevalence)

  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.

  12 months

• Cumulated time with toxicity (area under the curve)

  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

  12 months

Secondary Outcomes (12)

• Time with erectile dysfunction (duration)

  12 months

• Time with erectile dysfunction (prevalence)

  12 months

• Time with erectile dysfunction (Area under the curve)

  12 months

• Time with urinary incontinence (duration)

  12 months

• Time with urinary incontinence (prevalence)

  12 months

Study Arms (1)

TOOKAD VTP

EXPERIMENTAL

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

Interventions

TOOKAD VTP DRUG

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.

TOOKAD VTP

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Steba Biotech S.A.: lead
• International Drug Development Institute: collaborator
• PrimeVigilance Ltd., UK: collaborator

Study Sites (1)

Centre Hospitalier Universitaire (CHU)

Angers, France

Location

Study Officials

• Abdel-Rahmène AZZOUZI, Professor

  Centre Hospitalier Universitaire (CHU) ANGERS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multiple center, single-arm, open-label, 12-month follow-up phase IV pragmatic clinical trial.

Study Record Dates

• First Submitted: January 24, 2019
• First Posted: February 21, 2019
• Study Start: January 21, 2019
• Primary Completion: November 13, 2020
• Study Completion: November 13, 2020
• Last Updated: March 23, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)