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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:
- a follow-up of patients via investigators
- and a follow-up via interviews directly with patients
no intervention (post study follow up)
Department of Urology-Tampere University Hospital-
Active, not recruiting
Steba Biotech S.A.
Published on BioPortfolio: 2019-07-15T10:04:58-0400
This is a prospective evaluation to determine the effectiveness of the Prostate Cancer Supportive Care (PCSC) Program's group therapy program, Living with Prostate Cancer (LPC). LPC is an ...
This research study is being done to collect regular and routine follow-up information related to the outcome of treatment for prostate cancer. This study is also being done to relate tre...
Single center, single-arm, open-label, 60-month follow-up phase IIb clinical trial. Men with localized prostate cancer will receive TOOKAD® Soluble VTP under general anesthesia. To evalu...
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Randomized trial evaluating the role of weight loss in overweight and obese men with early stage prostate Cancer on active surveillance: Rationale and design of the Prostate Cancer Active Lifestyle Study (PALS).
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A glycoprotein that is a kallikrein-like serine proteinase and an esterase, produced by epithelial cells of both normal and malignant prostate tissue. It is an important marker for the diagnosis of prostate cancer.
Study subjects in COHORT STUDIES whose outcomes are unknown e.g., because they could not or did not wish to attend follow-up visits.(from Dictionary of Epidemiology, 5th ed.)
A study in which observations are made before and after an intervention, both in a group that receives the intervention and in a control group that does not.
A study that uses observations at multiple time points before and after an intervention (the "interruption"), in an attempt to detect whether the intervention has had an effect significantly greater than any underlying trend over time.
A synthetic retinoid that is used orally as a chemopreventive against prostate cancer and in women at risk of developing contralateral breast cancer. It is also effective as an antineoplastic agent.
Cancer is not just one disease but many diseases. There are more than 100 different types of cancer. Most cancers are named for the organ or type of cell in which they start - for example, cancer that begins in the colon is called colon cancer; cancer th...
Prostate cancer (cancer de prostata) Prostate cancer (cancer de prostata) is a form of cancer that develops in the prostate, a gland in the male reproductive system. Most prostate cancers are slow growing; however, there are cases of aggressive prostat...
Benign Prostatic Hyperplasia (BPH) Erectile Dysfunction Urology Urology is the branch of medicine concerned with the urinary tract and diseases that affect it. Examples include urethritis, urethrostenosis and incontinence. Urology is a su...