Neoplasms

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Urogenital Neoplasms

Male Urogenital Diseases

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Prostatic Diseases

Genital Diseases, Male

Genital Neoplasms, Male

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

Active surveillance is one of the management strategy in men who have low-risk prostate cancer

TOOKAD® Soluble-VTP procedure will consist of an IntraVenous (IV) administration to patients using a 753nm laser light at a fixed power of 150mW/cm and a fixed energy at 200J/cm delivered through transperineal interstitial optical fibers. The needles are positioned in the prostate under ultra sound image guidance

TOOKAD® Soluble

Mark Emberton, Professor

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).

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.

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

A European Randomised Phase 3 Study to Assess the Efficacy and Safety of TOOKAD® Soluble for Localised Prostate Cancer Compared to Active Surveillance

The data are available in case report form for each patient

Histological changes are assessed using biopsies or any other pathology result obtained during the study planned or not.

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

Number of patients undergoing a radical treatment for prostate cancer such as: radical prostatectomy, radiotherapy, brachytherapy divided by the total number of patients.

Total number of biopsy sample containing tumor cells at the month 24 biopsy

Number of patients experiencing urinary incontinence, erectile dysfunction or urinary symptoms events divided by the total number of patients.

Number of patients experiencing adverse events divided by the total number of patients.

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.

Results of the International Index of Erectile Function (IIEF) and International Prostate Symptoms Score (IPSS) patients questionaires.

Steba Biotech S.A.

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

Active surveillance is one of the management strategy in men who have intermediate risk localised prostate cancer

TOOKAD® -VTP procedure will consist of an IntraVenous (IV) administration to patients using a 753nm laser light at a fixed power of 150mW/cm and a fixed energy at 200J/cm delivered through transperineal interstitial optical fibers. The needles are positioned in the prostate under ultra sound image guidance

TOOKAD®

Jonathan Coleman, MD

Multi-center, prospective, randomized controlled clinical trial that will compare two treatment methods (PGA with TOOKAD® VTP and Active Surveillance) for treating localized prostate cancer. The study will include criteria for evaluation, biopsy, eligibility, informed consent, subsequent management and decision making conducted based on data provided locally at each center that follow a set of standardized criteria.

The primary endpoint requires follow-up through 30 months, but all subjects will be followed for 72 months regardless of initiation of other local or systemic prostate cancer treatments, which will allow assessments of recurrence rates and morbidity after conversion to radical therapy, long-term safety and tolerability, as well as oncologic outcomes.

This is multi-center, prospective, randomized controlled phase III clinical trial that will compare two treatment methods (PGA with TOOKAD® VTP and Active Surveillance) for treating localized prostate cancer who meet the inclusion criteria will be approached for participation in the clinical study. Patients consenting to participate will be individually randomized to TOOKAD® VTP or Active Surveillance with a 1:1 ratio. Central randomization will be performed using an independent web-based allocation system. Randomization will be stratified by center using minimization. Ongoing assessment of patients in both arms will be balanced, including follow up examinations, PSA testing, MRI and biopsies at defined intervals.

Subjects in the experimental arm will receive the experimental treatment consisting of unilateral TOOKAD® VTP treatment applied to the index lobe containing pattern 4 cancer. The treatment will be administered under general anesthesia. Routine ultrasound examination in the operating room will be performed for morphometric description of the prostate and to facilitate accurate treatment planning and probe placement. Ultrasound will not be used for diagnostic purposes.

Evaluation of Efficacy of TOOKAD® (VTP) Versus Active Surveillance for Intermediate Risk Localized Prostate Cancer

An Evaluation of the Efficacy of Partial Gland Ablation (PGA) With TOOKAD® Vascular Targeted Photodynamic Therapy (VTP) Versus Active Surveillance for Men With Intermediate Risk Localized Prostate Cancer

To evaluate the difference in the rate of objective progression of cancer between men treated with TOOKAD -VTP and men managed with Active Surveillance for localized prostate cancer.

To confirm the differences between men treated with VTP and men managed with Active Surveillance in overall rate of conversion to radical local or systemic therapy

To confirm the differences between men treated with VTP and men managed with Active Surveillance in overall rate of conversion to radical local or systemic therapy following objective progression

To confirm the differences between men treated with VTP and men managed with Active Surveillance in the rate of biopsy progression in the index lobe (the lobe initially diagnosed with GG2 cancer) defined as:

* Any Grade Group 3 or higher cancer in a biopsy core of the index lobe
* Increase in total length of Gleason pattern 4 \>1mm above baseline and \>2mm in total length in a follow-up biopsy of the index lobe

The rate of clinical local or distant progression defined as any of the following:

* Clinical stage ≥ T3N0M0 cancer
* MRI evidence of extracapsular extension of cancer (MRI read as "definite", "frank" or "gross" ECE, or MRI lesion with \>10mm capsular contact) in an area with biopsy proven cancer.
* Seminal vesicle invasion, identified as "probable" or "definite," on DRE or MRI
* Radiographically suspicious lymph node involvement confirmed with biopsy or PET scan.
* Metastatic disease
* Prostate cancer-specific death

The rate, severity, onset and duration of adverse events (AEs) and serious adverse events (SAEs)

The FACT-P is a multidimensional, self-report QoL instrument specifically designed for use with prostate cancer patients. It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being. Only Question GP5 will be assessed to determine bother related to adverse events.

The NCI Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) is a new patient-reported outcome measurement system developed to characterize the frequency, severity and interference of 78 symptomatic treatment toxicities. These include symptomatic toxicities such as pain, fatigue, nausea, and cutaneous side effects such as rash and hand-foot syndrome, all toxicities that can be meaningfully reported from the patient perspective. Only Urinary Questions 61 - 65 will be assessed

The NCI Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) is a new patient-reported outcome measurement system developed to characterize the frequency, severity and interference of 78 symptomatic treatment toxicities. These include symptomatic toxicities such as pain, fatigue, nausea, and cutaneous side effects such as rash and hand-foot syndrome, all toxicities that can be meaningfully reported from the patient perspective.Only Pain Question 48 will be assessed

The NCI Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) is a new patient-reported outcome measurement system developed to characterize the frequency, severity and interference of 78 symptomatic treatment toxicities. These include symptomatic toxicities such as pain, fatigue, nausea, and cutaneous side effects such as rash and hand-foot syndrome, all toxicities that can be meaningfully reported from the patient perspective. Only Bowel Symptoms questions 17 and 18 will be assessed

The NCI Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) is a new patient-reported outcome measurement system developed to characterize the frequency, severity and interference of 78 symptomatic treatment toxicities. These include symptomatic toxicities such as pain, fatigue, nausea, and cutaneous side effects such as rash and hand-foot syndrome, all toxicities that can be meaningfully reported from the patient perspective. Only Sexual Function questions 66-68 and 70-72 will be assessed

The NCI Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) is a new patient-reported outcome measurement system developed to characterize the frequency, severity and interference of 78 symptomatic treatment toxicities. These include symptomatic toxicities such as pain, fatigue, nausea, and cutaneous side effects such as rash and hand-foot syndrome, all toxicities that can be meaningfully reported from the patient perspective.Only Anxiety question 54 will be assessed

The Memorial Anxiety Scale for Prostate Cancer (MAX-PC) has been developped to facilitate the identification and assessment of men with prostate cancer-related anxiety. This scale consists of three subscales that measure general prostate cancer anxiety, anxiety related to prostate specific antigen (PSA) levels in particular, and fear of recurrence. Only Anxiety Questions 15-18 will be assessed

The physician will evaluate the ease or difficulties of radical, local or systemic therapy after VTP procedure using a scale . The instrument to be used to assess feasibility of performing RT will be a 5-point Likert Scale.

The question may be similar to the following:

"What was the difficulty in performing radical treatment on the subject" and proposed anwers will be: None, Minimal, Moderate, Severe or Extreme

Safety recorded as incidence of Adverse events and Serious Adverse Events

Biochemical Response recorded as serum PSA change as absolute measurement in ng/dL and as percentage increase or decrease over time

Clinical recurrence recorded as physician recorded objective recurrence of tumor on physical exam or imaging.

Identification of the primary cause for conversion to radical treatment as assessed by physician:

* Pre-defined cancer progression
* Changes in clinical parameters in absence of objective progression (physicial examination findings, PSA, imaging (MRI, CT, PET), biopsy, or other tests to be documented such as genomic tests)
* Significant change in anxiety about prostate cancer (Defined as increase of last MAX-PC (Memorial Anxiety Scale for Prostate Cancer)-fear of recurrence score prior to conversion to radical therapy by 3 points or more vs. baseline) in the absence of objective progression or change in clinical parameters
* Patient preference in absence of objective progression, change in clinical parameters, or documented prostate cancer anxiety

Assessment of PSA level in predicting or monitoring oncologic outcomes of local recurrence, and local or systemic progression. PSA serum level to be recorded as ng/ml

Assessment of PSA density in predicting or monitoring oncologic outcomes of local recurrence, and local or systemic progression. PSA density is calculated as total PSA (ng/ml) divided by prostate volume (ml).

Assessment of PSA kinetics in predicting or monitoring oncologic outcomes of local recurrence, and local or systemic progression. PSA kinetics is evaluated as change in PSA serum level in ng/ml over time.

Change in size of initial lesion on MRI in cm3

Change in PIRADS v2 Score of initial lesion

Changes in imaging results to indicate potential progression of prostate cancer outside the prostate gland (Changes in level of suspicion for Extra Capsular Extension (ECE), Semical vesicle invasion (SVI), Lymph node (LN) metastases used to identify local recurrence, and local, regional or distant progression).

Behaviors and Mental Disorders

Quality of Life

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

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.

Jose Arturo Rodriguez Rivera, Dr

Mary Lol Ve Mendoza Medina, Dr

Luis Zegarra Montes, Professor

Ramón Rodriguez, Professor

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.

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.

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

Study of the Efficacy,Safety and Quality of Life After TOOKAD® Soluble Vascular Targeted Photodynamic Therapy (VTP) for Minimally Invasive Treatment of Localized Prostate Cancer

Number of patients with a negative biopsy.

Patients' reported outcome measures (PROMs) impairment: urinary symptoms using IPSS and erectile functions using IIEF. Quality of life using EQ5D will also be described

Total length of cancer present in all cores taken in any given biopsy session

Severe prostate cancer related events: cancer extension to T3, metastasis or prostate cancer-related death.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Efficacy and Safety Study of TOOKAD® Soluble for Localised Prostate Cancer Compared to Active Surveillance.	NCT01310894	Prostate Cancer	TOOKAD® Soluble	18 Years -	Steba Biotech S.A.
Efficacy and Safety Study of TOOKAD® Soluble for Localised Prostate Cancer Compared to Active Surveillance.	NCT01310894	Prostate Cancer	TOOKAD® Soluble	18 Years -	Steba Biotech S.A.
Evaluation of Efficacy of TOOKAD® (VTP) Versus Active Surveillance for Intermediate Risk Localized Prostate Cancer	NCT04225299	Localized Prost...	TOOKAD®	18 Years -	Steba Biotech S.A.
Efficacy,Safety and Quality of Life After TOOKAD® Soluble VTP for Localized Prostate Cancer	NCT01875393	Prostate Cancer	TOOKAD® Soluble	18 Years -	Steba Biotech S.A.

Spots Global Cancer Trial Database for genital neoplasm,male