Systemic therapy in advanced or metastatic prostate cancer: evaluation of d... | Recruiting
Systemic therapy in advanced or met... | Recruiting
Systemic therapy in advanced or metastatic prostate cancer: evaluation of drug efficacy
STAMPEDE

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Medical Conditions
  • Prostate adenocarcinoma
Primary Contact Details
Prof Nicholas James
See all trial contact details
Recruitment Status
Recruiting
Trial source and source ID number
ISRCTN78818544
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Summary
http://www.cancerhelp.org.uk/trials/a-trial-looking-at-hormone-therapy-with-zoledronic-acid-docetaxel-or-celecoxib-for-prostate-cancer
Research Details
  • Current hypothesis as of 15/01/2018:
    Original Comparisons: Research interventions will improve survival over standard-of-care (SOC)
    Abiraterone Comparison: Addition of abiraterone to SOC will improve survival over SOC alone
    M1/RT Comparison: Addition of radiotherapy to SOC will improve survival over SOC alone
    Enzalutamide and Abiraterone Comparison: Addition of enzalutamide, in combination with abiraterone, to SOC will improve survival over SOC alone
    Metformin Comparison: Addition of metformin to SOC will improve survival over SOC alone
    Transdermal Oestradiol Comparison: Transdermal oestrdiol will be non-inferior to standard hormone therapy, while having fewer side-effects and improved quality of life

    Previous hypothesis:
    Updated 11/09/2008:
    Prostate cancer accounts for around one fifth of all cancers among men. In the UK there are around 25,000 new cases of prostate cancer each year, and around 10,000 deaths. Most men are given hormone therapy if their prostate cancer has spread (metastasised), or if the cancer is very likely to spread. This usually stops the tumour from growing for a while. However, in most cases over time the tumour will start to grow again. The trial is testing how well three new drugs work to prevent the tumour from growing again. The drugs are called celecoxib, docetaxel and zoledronic acid and are used with the hormone therapy.

    Updated 23/01/2013:
    Recruitment to the celecoxib arms (D and F) is now closed. An additional arm containing abiraterone was added in protocol version 8.0. A further comparison arm involving prostate radiotherapy for patients with metastatic disease is added in the current protocol version 9.0. The trial has multiple arms; the control arm of the trial is androgen deprivation therapy (ADT) only, achieved through the use of luteinising hormone releasing hormone (LHRH) analogues or LHRH antagonists, or bilateral orchidectomy according to local practice.

    Updated 29/07/2014:
    Recruitment to the zoledronic acid, docetaxel and abiraterone arms (B, C, E and G) have completed recruitment. Protocol version 12.0 was released on 29/07/2014. This includes the addition of arm J which adds abiraterone and enzalutamide to androgen deprivation therapy (ADT).
Phase
Phase II/III
Study Design
Randomised controlled trial
Study Type
Interventional
Intervention

Current interventions as of 15/01/2018:
Currently recruiting interventions as of 19/10/2017
Arm A = Standard of Care - control
Arm K = ADT + Metformin (included from protocol version 15.0)
Arm L = Transdermal Oestradiol therapy (included from protocol version 16.0)

Standard-of-Care: Standard forms of background treatment permitted as part of the STAMPEDE protocol which include licensed androgen deprivation therapy (e.g. LHRH analogues) given in the setting of hormone-naïve prostate cancer and first-line use of docetaxel.
Metformin: This anti-diabetic medication is proposed to have both anti-cancer effects and may help prevent the adverse metabolic effects of long-term ADT.
Transdermal Oestradiol: This form of hormone treatment which can suppress testosterone as effectively as standard ADT and has been shown to avoid some of the side-effects. For example, treatment with transdermal oestradiol does not appear to cause the bone to thin which is a common problem with standard forms of ADT. It may also help to avoid some of the side effects and therefore improve overall quality of life compared with standard forms of ADT.

Interventions closed to recruitment as of 19/10/2017
Arm B = ADT + zoledronic acid
Arm C = ADT + docetaxel
Arm D = ADT + celecoxib
Arm E = ADT + zoledronic acid + docetaxel
Arm F = ADT + zoledronic acid + celecoxib
Arm G = ADT + abiraterone
Arm H = ADT + radiotherapy to the prostate
Arm J = ADT + abiraterone + enzalutamide

Zoledronic acid: Prostate cancer cells can spread to bones and weaken them. Zoledronic acid is a drug that reduces bone destruction and hardens bones. This may make them more resistant to attack by cancer cells.
Docetaxel & Prednisolone: A drug that stops cells replicating that is currently being used to treat a range of cancers including lung, breast and ovarian cancer as well as prostate cancer. Docetaxel prolongs survival in men with relapsed metastatic prostate cancer.
Celecoxib: An aspirin-like drug that is used to treat arthritis. It slows down the growth of cancer cells in the laboratory. We wished to see if it had the same effect on cancer cells in patients. Recruitment to new patients for the evaluation of this drug is finished as a planned interim analysis failed to demonstrate sufficient activity.
Abiraterone Acetate & Prednisolone: An inhibitor of steroid hormone synthesis that blocks prostate cancer cells from generating their own male hormones. This is thought to be a major way in which prostate cancer cells resume growth following castration based therapies. The agent prolongs survival when given to men following failure of docetaxel chemotherapy.
Prostate radiotherapy: A treatment with high-energy x-rays targeted to the prostate gland. This treatment is now mandatory for patients with cancer that is confined to the prostate gland as large trials have shown it improves survival times. We are not certain whether we should give radiotherapy to the prostate if the cancer has already spread.
Enzalutamide: An androgen receptor signaling inhibitor and has gained recent approval for use on its own in the treatment of advanced CRPC, and there is evidence of activity for hormone-naïve prostate cancer.

Current interventions as of 29/07/2014:
Arm A = Androgen deprivation therapy (ADT) - control
Arm H = ADT + radiotherapy to the prostate (included from protocol version 9.0)
Arm J = ADT + abiraterone + enzalutamide (included from protocol version 12.0)

1. Prostate radiotherapy (included from protocol version 9.0): treatment with high-energy x-rays targeted to the prostate gland. This treatment is now mandatory for patients with cancer that is confined to the prostate gland as large trials have shown it improves survival times. We are not certain whether we should give radiotherapy to the prostate if the cancer has already spread.
2. Abiraterone (included from protocol version 8.0): An inhibitor of steroid hormone synthesis that blocks prostate cancer cells from generating their own male hormones. This is thought to be a major way in which prostate cancer cells resume growth following castration based therapies. The agent prolongs survival when given to men following failure of docetaxel chemotherapy.
3. Enzalutamide is a androgen receptor signalling inhibitor and has gained recent approval for use on its own in the treatment of advanced CRPC,(50) and there is evidence of activity for hormone-naïve prostate cancer.

Previous interventions from 23/01/2013 to 29/07/2014:
Arm A = Androgen deprivation therapy (ADT) - control
Arm B = ADT + zoledronic acid
Arm C = ADT + docetaxel
Arm D = ADT + celecoxib
Arm E = ADT + zoledronic acid + docetaxel (NOW CLOSED)
Arm F = ADT + zoledronic acid + celecoxib (NOW CLOSED)
Arm G = ADT + abiraterone (included from protocol version 8.0):
Arm H = ADT + radiotherapy to the prostate (included from protocol version 9.0)

1. Zoledronic acid: Prostate cancer cells can spread to bones and weaken them. Zoledronic acid is a drug that reduces bone destruction and hardens bones. This may make them more resistant to attack by cancer cells.
2. Docetaxel: A drug that stops cells replicating that is currently being used to treat a range of cancers including lung, breast and ovarian cancer as well as prostate cancer. Docetaxel prolongs survival in men with relapsed metastatic prostate cancer.
3. Celecoxib: An aspirin-like drug that is used to treat arthritis. It slows down the growth of cancer cells in the laboratory. We wished to see if it had the same effect on cancer cells in patients. Recruitment to new patients for the evaluation of this drug is finished as a planned interim analysis failed to demonstrate sufficient activity.
4. Abiraterone (included from protocol version 8.0): An inhibitor of steroid hormone synthesis that blocks prostate cancer cells from generating their own male hormones. This is thought to be a major way in which prostate cancer cells resume growth following castration based therapies. The agent prolongs survival when given to men following failure of docetaxel chemotherapy.
5. Prostate radiotherapy (included from protocol version 9.0): treatment with high-energy x-rays targeted to the prostate gland. This treatment is now mandatory for patients with cancer that is confined to the prostate gland as large trials have shown it improves survival times. We are not certain whether we should give radiotherapy to the prostate if the cancer has already spread.

Previous interventions until 23/01/2013:
Patients will be randomised to the control arm (Arm A) or one of the five investigational arms. All patients will receive androgen suppression (AS) to
castration level. The method of AS is a local choice but must be specified for each patient prior to randomisation. All trial treatments should commence as soon as practically possible after randomisation. Patients
having a bilateral orchidectomy should commence any additional treatment within four weeks of the operation unless there is a strong clinical reason not
to do so.

Arm A = Androgen suppression (AS) - control
Arm B = AS + zoledronic acid
Arm C = AS + docetaxel
Arm D = AS + celecoxib
Arm E = AS + zoledronic acid + docetaxel
Arm F = AS + zoledronic acid + celecoxib

Intervention Type
Drug
Primary Outcome Measures
    Current primary outcome measures as of 15/01/2018:
    Pilot phase: Safety
    Efficacy Stage I-III: Failure-free survival (FFS)
    Efficacy Stage IV: Overall survival

    Previous as of 11/09/2008:
    Pilot phase: Safety
    Efficacy Stage I-III: Failure-free survival (FFS)
    Efficacy Stage IV: Overall survival
Secondary Outcome Measures
    Current secondary outcome measures as of 15/01/2018:
    Pilot phase:
    Feasibility

    Efficacy Stage I-III:
    1. Overall survival (OS)
    2. Toxicity
    3. Skeletal related events

    Efficacy Stage IV:
    1. Quality of life
    2. Cost effectiveness
    3. Failure-free survival†
    4. Toxicity
    5. Skeletal related events

    Previous as of 11/09/2008:
    Pilot phase:
    1. Feasibility

    Efficacy Stage I-III:
    2. Overall survival (OS)
    3. Toxicity
    4. Skeletal related events

    Efficacy Stage IV:
    1. Quality of life
    2. Cost effectiveness
    3. Failure-free survival†
    4. Toxicity
    5. Skeletal related events
Publication(s)
2008 results in https://www.ncbi.nlm.nih.gov/pubmed/18728279
2009 results in https://www.ncbi.nlm.nih.gov/pubmed/19519885
2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22452894
2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22978443
2013 results in https://www.ncbi.nlm.nih.gov/pubmed/23578233
2014 results in https://www.ncbi.nlm.nih.gov/pubmed/24985962
2015 results in https://www.ncbi.nlm.nih.gov/pubmed/26718929
2015 results in http://www.ncbi.nlm.nih.gov/pubmed/26719232
2015 results in https://www.ncbi.nlm.nih.gov/pubmed/25301760
2016 results in http://www.ncbi.nlm.nih.gov/pubmed/26606329
2016 results in https://www.ncbi.nlm.nih.gov/pubmed/27450106
2017 results in https://www.ncbi.nlm.nih.gov/pubmed/28300506
2017 results in https://www.ncbi.nlm.nih.gov/pubmed/28578639
Result Reports
Sorry, this information is not available
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Male
Age Range
Adult
Who Can Participate
Patient
Number of Participants
8,100
Participant Inclusion Criteria
    Current inclusion criteria as of 23/01/2013:
    Patients must fulfil both of the criteria in Section 1 or one criterion in Section 2 or at least one criteria in Section 3. Additionally, all patients must fulfil the criteria in Section 4.

    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)

    OR
    2. NEWLY DIAGNOSED METASTATIC OR NODE-POSITIVE DISEASE - At least one of:
    2.1. Stage Tany N+ M0
    2.2. Stage Tany Nany M+

    OR
    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
    3.2. PSA ≥ 20 ng/ml
    3.3. N+
    3.4. M+

    AND
    4. FOR ALL PATIENTS
    4.1. Histologically confirmed prostate adenocarcinoma
    4.2. Intention to treat with long-term androgen deprivation therapy
    4.3. Fit for all protocol treatment2 and follow-up, WHO performance status 0-23
    4.4 Have completed the appropriate investigations prior to randomisation
    4.5. Adequate haematological function: neutrophil count >1.5x109/l and platelets >100x109/l
    4.6. Estimated creatinine clearance >30ml/min
    4.7. Serum potassium ≥3.5mmol/L
    4.8. Written informed consent
    4.9. Willing and expected to comply with follow-up schedule
    4.10. Using effective contraceptive method if applicable

    Previous inclusion criteria until 23/01/2013:
    Patients must fulfil one of the inclusion criteria in section one or one of the inclusion criteria in section two. Additionally, all patients must fulfil the inclusion criteria in section three:

    Section one - high risk newly diagnosed patients must fulfil one of the following criteria:
    1. Stage T3/4 N0 M0 histologically confirmed prostate adenocarcinoma with Prostate Specific Antigen (PSA) = 40 ng/ml or Gleason sum score eight to ten
    2. Stage Tany N + M0 or Tany Nany M + histologically confirmed prostate adenocarcinoma
    3. Multiple sclerotic bone metastases with a PSA = 100 ng/ml

    Section two - patients with histologically confirmed prostate adenocarcinoma previously treated with radical surgery or radiotherapy that are now relapsing. (Please note that prior hormone therapy for localised disease must have been completed 12 months previously, have been no longer than 12 months in duration and given as adjuvant or neoadjuvant therap:
    1. PSA = 4 ng/ml and rising with doubling time less than six months
    2. PSA = 20 ng/ml

    Section three - for all patients:
    1. Intention to treat with long-term androgen suppression
    2. Fit for all protocol treatment and follow-up, World Health Organisation (WHO) performance status zero to two
    3. Have completed the appropriate investigations prior to randomisation
    4. Adequate haematological function: neutrophil count more than 1.5 x 10^9 l and platelets more than 100 x 10^9 l
    5. Adequate renal function: Serum creatinine less than 1.5 Upper Limit of Normal (ULN)
    6. Adequate liver function: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) less than 1.5 ULN, bilirubin less than ULN
    7. Normal testosterone level prior to treatment
    8. Written informed consent
    9. Willing and expected to comply with follow-up schedule
Participant Exclusion Criteria
    Current exclusion criteria as of 16/01/2018:
    Patients must not fulfil any of the criteria, below.
    1. Prior systemic therapy for locally-advanced or metastatic prostate cancer except as listed in 1.3
    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 patients 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. Patients with significant cardiovascular disease, including:
    6.1. Severe/unstable angina
    6.2. Myocardial infarction less than 6 months prior to randomisation
    6.3. Arterial thrombotic events less than 6 months prior to randomisation
    6.4. Clinically significant cardiac failure requiring treatment (NYHA II-IV)³
    6.5. Cerebrovascular disease (e.g. stroke or transient ischemic episode) less than 6 months prior to randomisation
    6.6. Patients with uncontrolled hypertension defined as systolic BP greater or equal than 160mmHg or diastolic BP greater or equal than 95mmHg⁴
    6.7. Or any other significant cardiovascular disease that in the investigator’s opinion means the patient is unfit for any of the study treatments
    7. Prior chemotherapy for prostate cancer (excluding patients receiving docetaxel as part of the new SOC)
    8. Prior exposure to long-term hormone therapy before randomisation
    9. Prior exposure to systemic treatment for prostate cancer (excluding hormone therapy) e.g. abiraterone and enzalutamide

    Comparison-Specific Selection Criteria
    Metformin Comparison
    1. Patients with known diabetes mellitus are not eligible for randomisation. All non-diabetic patients require an HbA1c to be performed prior to randomisation (ideal timeline: within 8 weeks prior to randomisation), to confirm their non-diabetic status.
    2. HbA1c <48mmol/mol (equivalent to <6.5%)
    3. Adequate renal function, defined as GFR ≥45ml/min/1.73m²
    4. No history of lactic acidosis or pre-disposing conditions
    5. Not current or previous treatment with metformin
    6. No contra-indications to metformin

    Transdermal Oestradiol Comparison
    Patients who have any of the following are not eligible for the transdermal oestradiol comparison
    1. >8 weeks of anti-androgen use
    2. >1 dose of monthly or 4 weekly LHRH agonist/antagonist
    3. Prior LHRH agonist injection with a stated duration of effect greater than 1 month
    4. >12 weeks since first dose of any hormone therapy
    5. Bilateral orchidectomy
    6. Cyproterone acetate started prior to randomisation
    7. Known porphyria
    8. Any history of deep vein thrombosis or pulmonary embolism confirmed radiologically
    Known thrombophilic disorder (e.g. Protein C, Protein S, antithrombin deficiency)

    Current exclusion criteria as of 29/07/2014:
    1. Prior systemic therapy for locally advanced or metastatic prostate cancer except as listed in Section 4.1.3
    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 patients 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 physician, is likely to interfere with STAMPEDE treatment or assessment
    5. Patients with contra-indications to prednisolone, including active peptic ulceration or a history of gastrointestinal bleeding
    6. Patients with active inflammatory bowel disease
    7. Symptomatic peripheral neuropathy grade 2 (NCI CTC)5
    8. Any surgery (e.g. TURP) performed within the past 4 weeks
    9. Patients with significant cardiovascular disease such that, in the investigator's opinion, the patient is unfit for any of the study treatments. This might include:
    9.1. Severe/unstable angina
    9.2. Myocardial infarction less than 6 months prior to randomisation
    9.3. Arterial thrombotic events less than 6 months prior to randomisation
    9.4. Clinically significant cardiac failure requiring treatment (NYHA II-IV)6
    9.5. Cerebrovascular disease (e.g. stroke or transient ischaemic episode) less than 2 years prior to randomisation
    9.6. Patients with uncontrolled hypertension defined as systolic BP greater or equal than 160 mmHg or diastolic BP greater or equal than 95 mmHg
    10. Patients receiving treatment with drugs known to induce CYP3A4 (including phenytoin, carbamazepine, Phenobarbital)7
    11. Prior exposure to abiraterone
    12. Prior exposure to enzalutamide
    13. Prior chemotherapy for prostate cancer
    14. Prior therapy with zoledronic acid or other bisphosphonates other than treatment for hypercalcaemia or low bone density
    15. Prior exposure to policy of long-term hormone therapy before randomisation (unless as described in Section 4.4.2)
    16. History of seizure including any febrile seizure, loss of consciousness, or transient ischaemic attack within 12 months of randomisation or any condition that may pre-dispose to seizure (e.g., prior stroke, brain arteriovenous malformation, head trauma with loss of consciousness requiring hospitalization)
    17. Unexplained history of loss of consciousness within 12 months of randomisation
    18. Operation of heavy machinery during treatment

    SELECTION CRITERIA FOR COMPARISON OF RESEARCH (M1) RT FOR METASTATIC DISEASE
    All patients meeting criteria the above criteria are eligible for the trial, but not all can be allocated to the research (M1) radiotherapy arm. The selection criteria for this 'RT to the prostate' comparison are:
    1. Newly-diagnosed prostate cancer
    2. Demonstrable M1 disease
    3. No contraindication to radiotherapy e.g. no previous pelvic radiotherapy and no history of inflammatory bowel disease
    4. No previous radical prostatectomy

    Any patients meeting these criteria will have a chance to be allocated to Arm H.

    Previous exclusion criteria from 23/01/2013 to 29/07/2014:
    1. Prior systemic therapy for locally advanced or metastatic prostate cancer except as listed in Section 4.1.3.
    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 patients 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 physician, is likely to interfere with STAMPEDE treatment or assessment
    5. Patients with active peptic ulceration, gastrointestinal bleeding, inflammatory bowel disease
    6. Symptomatic peripheral neuropathy grade 2 (NCI CTC)5
    7. Any surgery (e.g. TURP) performed within the past 4 weeks
    8. Patients with significant cardiovascular disease such that, in the investigator's opinion, the patient is unfit for any of the study treatments. This might include:
    8.1. Severe/unstable angina
    8.2. Myocardial infarction less than 6 months prior to randomisation
    8.3. Arterial thrombotic events less than 6 months prior to randomisation
    8.4. Clinically significant cardiac failure requiring treatment (NYHA II-IV)6
    8.5. Cerebrovascular disease (e.g. stroke or transient ischaemic episode) less than 2 years prior to randomisation
    8.6. Patients with uncontrolled hypertension defined as systolic BP greater or equal than 160 mmHg or diastolic BP greater or equal than 95 mmHg
    9. Patients who have been scheduled to have major dental extractions within the next 2 years
    10. Patients receiving treatment with drugs known to induce CYP3A4 (including phenytoin, carbamazepine, Phenobarbital)7
    11. Prior exposure to abiraterone
    12. Prior chemotherapy for prostate cancer
    13. Prior therapy with zoledronic acid other than short-term treatment for hypercalcaemia
    14. Prior exposure to policy of long-term hormone therapy before randomisation (unless as described in Section 4.4.2 of the protocol)

    SELECTION CRITERIA FOR COMPARISON OF RESEARCH (M1) RT FOR METASTATIC DISEASE
    All patients meeting criteria above are eligible for the trial, but not all can be allocated to the research (M1) radiotherapy arm. The selection criteria for this “RT to the prostate” comparison are:
    1. Newly diagnosed prostate cancer
    2. Demonstrable M1 disease
    3. No contraindication to radiotherapy e.g. no previous pelvic radiotherapy,
    4. No previous radical prostatectomy
    Patients meeting these criteria will have a chance to be allocated to Arms A and H.

    Previous exclusion criteria until 23/01/2013:
    1. Prior systemic therapy for locally advanced or metastatic prostate cancer except as listed in section two
    2. Metastatic brain disease or leptomeningeal disease
    3. Any other previous or current malignant disease which, in the judgement of the responsible physician, is likely to interfere with STAMPEDE treatment or assessment
    4. Symptomatic peripheral neuropathy grade two (National Cancer Institute Common Toxicity Criteria [NCI CTC])
    5. Any surgery (e.g. transurethral resection of the prostate [TURP]) performed within the past four weeks
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Pfizer Investigational Site
Birmingham
B15 2TT
Trial Contact(s)
Primary Trial Contact
Prof Nicholas James
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
Switzerland, United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
Systemic therapy in advanced or metastatic prostate cancer: evaluation of drug efficacy
EudraCT Number
2004-000193-31
Funder(s)
  • Cancer Research UK (UK)
Other Study ID Numbers
N/A
Sponsor(s)
Medical Research Council (UK)
Key Dates

Recruitment Start Date

17 Oct 2005

Recruitment End Date

01 Dec 2020

Trial Start Date

17 Oct 2005

Trial End Date

01 Dec 2024

Date added to source

03 Aug 2004

Date updated in source

16 Jan 2018