A Phase 3 interventional study of TOOKAD® Soluble in Prostate Cancer, sponsored by Steba Biotech S.A.. Completed at 51 sites in 10 countries. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-11.
Sponsored by Steba Biotech S.A. · Phase 3, Interventional, and Treatment
The aims of this study are:
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.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's enrollment of 413 is above the median of 60 across 5,348 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Steba Biotech S.A. is the lead sponsor of 13 studies on the registry; none are open to participants now.
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Subjects will be eligible for inclusion in the study if all of the following criteria are met:
Low risk prostate cancer diagnosed using one transrectal ultrasound guided (TRUS)using from 10 to 24 cores performed less than 12 months prior to enrolment, and showing the following:
Exclusion Criteria:
Subjects will not be eligible for the study if meeting any of the following criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TOOKAD® Soluble, lyophilized formulation, given at a dose of 4mg/Kg.
Drug: TOOKAD® Soluble
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
Also known as: WST11
Co-primary endpoint 'A': Rate of absence of definite cancer using patients on active surveillance as a comparison.
Histological changes are assessed using biopsies or any other pathology result obtained during the study planned or not.
Time frame: Month 24
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.
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
Time frame: Over 24 months follow-up.
The rate of additional prostate cancer radical therapy
Number of patients undergoing a radical treatment for prostate cancer such as: radical prostatectomy, radiotherapy, brachytherapy divided by the total number of patients.
Time frame: Over 24 months follow-up
Total number of cores positive for cancer
Total number of biopsy sample containing tumor cells at the month 24 biopsy
Time frame: Month 24
The rate of incontinence, erectile dysfunction, urinary symptoms
Number of patients experiencing urinary incontinence, erectile dysfunction or urinary symptoms events divided by the total number of patients.
Time frame: Randomisation visit, Day 7 after VTP , Month 3, Month 6, Month 9, Month 12, Month 24
The rate of adverse events
Number of patients experiencing adverse events divided by the total number of patients.
Time frame: Screening-Month 24
The rate of severe prostate cancer related events: cancer extension to T3, metastasis and prostate cancer related death
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.
Time frame: Screening-Month 24
The overall quality of life will be recorded for potential utility and descriptive studies.
Results of the International Index of Erectile Function (IIEF) and International Prostate Symptoms Score (IPSS) patients questionaires.
Time frame: Randomisation visit; Month 12; Month 24
Plan to share: Yes — The data are available in case report form for each patient
Time frame: Data available on request.
The record gives a start of Feb 2011, a primary completion of Jun 2015 and a completion of Aug 2015. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Padeliporfin
Steba Biotech S.A.