Systemic therapy in advanced or metastatic prostate cancer: evaluation of drug efficacy
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Prostate adenocarcinoma
- Sponsor
- niversity College London
- Enrollment
- 11992
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
2008 Results article in https://www.ncbi.nlm.nih.gov/pubmed/18728279 results 2009 Results article in https://www.ncbi.nlm.nih.gov/pubmed/19519885 results 2012 Results article in http://www.ncbi.nlm.nih.gov/pubmed/22452894 results 2012 Results article in http://www.ncbi.nlm.nih.gov/pubmed/22978443 results 2013 Results article in https://www.ncbi.nlm.nih.gov/pubmed/23578233 results 2014 Results article in https://www.ncbi.nlm.nih.gov/pubmed/24985962 results 2015 Results article in https://www.ncbi.nlm.nih.gov/pubmed/25301760 results 2016 Results article in https://www.ncbi.nlm.nih.gov/pubmed/26718929 results 2016 Results article in http://www.ncbi.nlm.nih.gov/pubmed/26606329 results 2016 Results article in http://www.ncbi.nlm.nih.gov/pubmed/26719232 results 2016 Results article in https://www.ncbi.nlm.nih.gov/pubmed/27450106 results 2017 Results article in https://www.ncbi.nlm.nih.gov/pubmed/28300506 results 2017 Results article in https://www.ncbi.nlm.nih.gov/pubmed/28578639 results 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35671327/ (added 08/06/2022)
Investigators
Eligibility Criteria
Inclusion Criteria
- •Participant inclusion criteria as of 14/11/2018:
- •Participants must fulfil all the criteria in one of the following three categories:
- •1\. HIGH\-RISK NEWLY DIAGNOSED NON\-METASTATIC NODE\-NEGATIVE DISEASE \- Both:
- •1\.1\. At least two of: Stage T3/4, PSA \= 40 ng/ml or Gleason sum score 8\-10
- •1\.2\. Intention to treat with radical radiotherapy (unless there is a contra\-indication; exemption can sought in advance of consent, after discussion with MRC CTU)
- •2\. NEWLY DIAGNOSED METASTATIC OR NODE\-POSITIVE DISEASE \- At least one of:
- •2\.1\. Stage Tany N\+ M0
- •2\.2\. Stage Tany Nany M\+
- •3\. PREVIOUSLY TREATED WITH RADICAL SURGERY AND/OR RADIOTHERAPY, NOW RELAPSING \- At least one of:
- •3\.1\. PSA \= 4 ng/ml and rising with doubling time less than 6 months
Exclusion Criteria
- •Participant exclusion criteria as of 14/11/2018:
- •1\. Prior systemic therapy for locally\-advanced or metastatic prostate cancer
- •2\. Metastatic brain disease or leptomeningeal disease
- •3\. Abnormal liver functions consisting of any of the following:
- •3\.1\. Serum bilirubin \=1\.5 x ULN (except for participants with Gilbert’s disease, for whom the upper limit of serum bilirubin is 51\.3µmol/l or 3mg/dl)
- •3\.2\. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \=2\.5 x ULN
- •4\. Any other previous or current malignant disease which, in the judgement of the responsible clinician, is likely to interfere with STAMPEDE treatment or assessment
- •5\. Any surgery (e.g. TURP) performed within the past 4 weeks
- •6\. Participants with significant cardiovascular disease, including:
- •6\.1\. Severe/unstable angina
Outcomes
Primary Outcomes
Not specified