Efficacy,Safety and Quality of Life After TOOKAD® Soluble VTP for Localized Prostate Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2015-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TOOKAD® Soluble

TOOKAD® Soluble, lyophilized formulation,given at a dose of 4 mg/kg.

Group Type EXPERIMENTAL

TOOKAD® Soluble

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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WST11

Eligibility Criteria

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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.
* Any condition or history of active rectal inflammatory bowel disease or other factors which may increase the risk of fistula formation;
* Any hormonal manipulation (excluding 5-alpha-reductase inhibitors) that alters androgen production or use of androgen supplements within the previous 6 months;
* Any history of urethral stricture disease;
* Any history of acute urinary retention within 6 months of study entry

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No