Efficacy and Safety Study of TOOKAD® Soluble for Localised Prostate Cancer Compared to Active Surveillance.

Phase 3

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: TOOKAD® Soluble

• Registration Number: NCT01310894
• Lead Sponsor: Steba Biotech S.A.

Brief Summary

The aims of this study are:

* to assess the impact of TOOKAD® Soluble-Vascular Targeted Photodynamic Therapy (VTP) on the rate of absence of definite cancer using patients on active surveillance as a comparison (co-primary objective A) and

* to determine the difference in rate of treatment failure associated with observed progression of disease from low risk prostate cancer to moderate or higher risk prostate cancer in men who undergo TOOKAD® Soluble-VTP compared to men on active surveillance (co-primary objective B).

Detailed Description

This is a Phase 3, multicentre, open label, randomised controlled study in subjects diagnosed with low risk prostate cancer on TransRectal Ultrasound (TRUS) guided biopsy.

Subjects will be randomised to either Active Surveillance or TOOKAD® Soluble VTP. Subjects will remain in the study for approximately 24 months following randomisation. A total of 400 subjects will be entered into the study; 200 will receive Active Surveillance and 200 will receive TOOKAD® Soluble-VTP.

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-03-01
• Study First Submitted QC: 2011-03-05
• Study First Posted: 2011-03-09
• Primary Completion: 2015-06
• Study Completion: 2015-08
• Status Verified: 2016-04
• Last Update Submitted: 2019-07-10
• Last Update Posted: 2019-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 413

Inclusion Criteria

Subjects will be eligible for inclusion in the study if all of the following criteria are met:

1. Low risk prostate cancer diagnosed using one transrectal ultrasound guided biopsy (TRUS)using from 10 to 24 cores performed less than 12 months prior to enrolment, and showing the following:

   • Gleason 3 + 3 prostate adenocarcinoma as a maximum,
   • Two (2) to three (3) cores positive for cancer
   • A maximum cancer core length of 5 mm in any core.

2. Cancer clinical stage up to T2a (pathological or radiological up to T2c disease permitted)

3. Serum prostate specific antigen (PSA) of 10 ng/mL or less

4. Prostate volume equal or greater than 25 cc and less than 70 cc.

5. Male subjects aged 18 years or older.

Exclusion Criteria

Subjects will not be eligible for the study if meeting any of the following criteria:

1. Unwillingness to accept randomisation to either of the two arms of the study
2. Any prior or current treatment for prostate cancer, including surgery, radiation therapy (external or brachytherapy) or chemotherapy.
3. Any surgical intervention for benign prostatic hypertrophy
4. Life expectancy less than 10 years.
5. Any condition or history of illness or surgery that may pose an additional risk to men undergoing the VTP procedure.
6. Participation in another clinical study or recipient of an investigational product within 1 month of study entry.
7. Subject unable to understand the patient's information document, to give consent or complete the study tasks.
8. Subject in custody and or in residence in a nursing home or rehabilitation facility
9. Contra-indication to Magnetic resonance Imaging (MRI) (e.g., pacemaker, history of allergic reaction to gadolinium), or factors excluding accurate reading of pelvic MRI (e.g., hip prosthesis)
10. Any condition or history of illness or surgery that may pose an additional risk to men undergoing the TOOKAD® Soluble VTP procedure.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TOOKAD® Soluble	TOOKAD® Soluble	TOOKAD® Soluble, lyophilized formulation, given at a dose of 4mg/Kg.

Primary Outcome Measures

Name	Time	Method
Co-primary endpoint 'A': Rate of absence of definite cancer using patients on active surveillance as a comparison.	Month 24	Histological changes are assessed using biopsies or any other pathology result obtained during the study planned or not.
Co-primary endpoint 'B': Difference in rate of treatment failure associated with observed progression of disease from low risk prostate cancer to moderate or higher risk prostate cancer.	Over 24 months follow-up.	Moderate or higher risk is defined as the observation of: * More than 3 cores positive for cancer when considering all histological examination available during follow-up of study; * or any Gleason primary or secondary pattern 4 or more; * or at least one cancer core length greater than 5 mm; * or PSA\>10ng/mL ( in 3 consecutive measures); * or any T3 prostate cancer,; * or metastasis; * or prostate cancer related death

Secondary Outcome Measures

Name	Time	Method
The rate of additional prostate cancer radical therapy	Over 24 months follow-up	Number of patients undergoing a radical treatment for prostate cancer such as: radical prostatectomy, radiotherapy, brachytherapy divided by the total number of patients.
The rate of incontinence, erectile dysfunction, urinary symptoms	Randomisation visit, Day 7 after VTP , Month 3, Month 6, Month 9, Month 12, Month 24	Number of patients experiencing urinary incontinence, erectile dysfunction or urinary symptoms events divided by the total number of patients.
The rate of adverse events	Screening-Month 24	Number of patients experiencing adverse events divided by the total number of patients.
Total number of cores positive for cancer	Month 24	Total number of biopsy sample containing tumor cells at the month 24 biopsy
The rate of severe prostate cancer related events: cancer extension to T3, metastasis and prostate cancer related death	Screening-Month 24	Number of patients experiencing severe prostate cancer related events: cancer extension to T3, metastasis and prostate cancer related death divided by the total number of patients.
The overall quality of life will be recorded for potential utility and descriptive studies.	Randomisation visit; Month 12; Month 24	Results of the International Index of Erectile Function (IIEF) and International Prostate Symptoms Score (IPSS) patients questionaires.

Trial Locations

Locations (50)

Dept. of Urology-University Hospitals Leuven; 🇧🇪 Leuven, Belgium

Department of Urology-Tampere University Hospital-; 🇫🇮 Tampere, Finland

Service d'Urologie - Centre Hospitalier Universitaire d'Angers; 🇫🇷 Angers, France

CHRU Hopital Jean Minjoz; 🇫🇷 Besançon, France

Site Médipole; 🇫🇷 Cabestany, France

Polyclinique Sévigné; 🇫🇷 Cesson Sévigné, France

Clinique d'Urologie et de Transplantation Rénale CHU Grenoble; 🇫🇷 Grenoble, France

Hôpital Claude Huriez; 🇫🇷 Lille, France

Hôpital La Conception; 🇫🇷 Marseille, France

Clinique Ambroise Paré; 🇫🇷 Neuilly sur Seine, France

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