An observational study in Cancer of the Prostate, sponsored by Steba Biotech S.A.. Completed at 36 sites in 8 countries. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-03-22.
Sponsored by Steba Biotech S.A. · Observational
This is an open observational extended follow-up study of patients originally randomized into TOOKAD® Soluble VTP therapy or active surveillance (control group). Additional 60-month follow-up study
This is an open observational extended follow-up study of patients originally randomized into TOOKAD® Soluble VTP therapy or active surveillance (control group). No intervention or further intervention with TOOKAD® Soluble is mandated in this additional 60-month follow-up study where patients in the original TOOKAD® Soluble group and active surveillance (control) group are both managed by their physician as appropriate to their condition using any treatment available following a 'local standard of care' principle from the end of the trial (M24) up to the end of follow-up (M84). Management decisions are entirely left to clinicians and their patients in this pragmatic extension of the trial (no criteria imposed) where standard of care that reflects clinical practice within each centre is applied.
All patients originally randomised in study CLIN1001 PCM301, whether allocated to the TOOKAD® Soluble VTP arm (n=206) or Active surveillance arm (n=207 and who did not withdraw their consent will be included in this extension study.
This extension study consists of 2 different follow-up:
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's enrollment of 374 is above the median of 200 across 1,310 observational 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.
Counted across the registry records on this site, refreshed daily.
Patients with localized low risk prostate cancer initialy randomized in the study CLIN 1001 PCM301
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
All subjects originally randomized in study CLIN1001 PCM301 are included in this follow-up study. As a reminder, they all met the following criteria at entry (from the original protocol):
Low risk prostate cancer diagnosed using one trans-rectal ultrasound guided (TRUS) using from 10 to 24 cores, within 12 months of enrolment and showing the following:
Exclusion Criteria:
As a reminder, all subjects originally randomized did not met the following criteria at entry (from the original protocol):
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.
Subjects randomized in the treatment arm (TOOKAD VTP treatment) in the initial period of the study.
Other: no intervention (post study follow up)
Subjects randomized in the control group (active surveillance) in the initial period of the study.
Other: no intervention (post study follow up)
No intervention (post study follow up)
Disease progression
Progression of disease from low risk prostate cancer to moderate or higher risk prostate cancer in men initially randomized to TOOKAD® Soluble VTP compared to men originally randomized on active surveillance.
Time frame: Over the 5 years of follow up
Other prostate cancer therapy
Use of other prostate cancer therapy: radical therapy (surgery, radiotherapy, cryotherapy, ultrasound therapy), hormonal therapy or chemotherapy or any therapy indicated for the treatment of prostate cancer in the countries of the study.
Time frame: Over the 5 years of follow up
Prostate cancer-related death.
Any death related to Prostate cancer
Time frame: Over the 5 years of follow up
Absence of cancer
The proportion of absence of cancer at biopsy (when available)
Time frame: Over the 5 years of follow up
Radical therapy
The rate of prostate cancer radical therapy;
Time frame: Over the 5 years of follow up
Cancer burden
The total cancer burden in the prostate
Time frame: Over the 5 years of follow up
Urinary incontinence
The description of incontinence in terms of mean, median, SD, inter-quartile ranges, min-max
Time frame: Over the 5 years of follow up
Erectile dysfunction
The description of erectile dysfunction in terms of mean, median, SD, inter-quartile ranges, min-max
Time frame: Over the 5 years of follow up
Urethral stenosis
The rate of urethral stenosis
Time frame: Over the 5 years of follow up
Prostate cancer complication
The rate of severe prostate cancer related events: cancer extension to T3, metastasis and prostate cancer related death
Time frame: Over the 5 years of follow up
Patients Questionnaires Quality of life
Overal Quality of Life will be recorded for potential utility and descriptives studies
Time frame: Over the 5 years of follow up
Plan to share: No
No publications or documents are linked to this record.
Ran from Mar 2016 to primary completion in Jun 2020, 50 months.
Of 541 non-industry observational studies under Prostatic Neoplasms, half reached primary completion within 67 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 162. This study's 50 months is below that.
Counting every sponsor, half of 650 studies reached it within 60 months; a quarter within 29 and three quarters within 141.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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Steba Biotech S.A.