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History of Changes for Study: NCT00268476
Androgen Suppression Alone or Combined With Zoledronate, Docetaxel, Prednisolone, and/or Celecoxib in Treating Patients With Locally Advanced or Metastatic Prostate Cancer
Latest version (submitted April 17, 2023) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 December 20, 2005 None (earliest Version on record)
2 January 12, 2006 Contacts/Locations and Study Status
3 February 6, 2006 Contacts/Locations and Study Status
4 February 9, 2006 Contacts/Locations and Study Status
5 April 5, 2006 Contacts/Locations, Arms and Interventions and Study Status
6 May 2, 2006 Contacts/Locations, Arms and Interventions and Study Status
7 May 16, 2006 Study Status and Contacts/Locations
8 May 23, 2006 Study Status
9 June 7, 2006 Study Status
10 September 29, 2006 Contacts/Locations and Study Status
11 November 8, 2006 Contacts/Locations, Study Design, Conditions, Study Status, Eligibility, Outcome Measures and Study Identification
12 December 4, 2006 Contacts/Locations and Study Status
13 January 11, 2007 Study Status
14 January 30, 2007 Sponsor/Collaborators, Eligibility and Study Status
15 February 8, 2007 Study Description and Study Status
16 February 20, 2007 Eligibility and Study Status
17 March 5, 2007 Arms and Interventions and Study Status
18 June 6, 2007 Contacts/Locations and Study Status
19 July 3, 2007 Contacts/Locations and Study Status
20 August 6, 2007 Arms and Interventions and Study Status
21 September 10, 2007 Contacts/Locations and Study Status
22 September 27, 2007 Contacts/Locations and Study Status
23 October 1, 2007 Contacts/Locations and Study Status
24 October 13, 2007 Contacts/Locations and Study Status
25 October 19, 2007 Arms and Interventions and Study Status
26 October 25, 2007 Arms and Interventions and Study Status
27 November 9, 2007 Contacts/Locations and Study Status
28 November 15, 2007 Arms and Interventions and Study Status
29 November 16, 2007 Contacts/Locations and Study Status
30 December 11, 2007 Contacts/Locations and Study Status
31 December 20, 2007 Contacts/Locations and Study Status
32 December 25, 2007 Study Status
33 January 3, 2008 Contacts/Locations and Study Status
34 February 6, 2008 Contacts/Locations and Study Status
35 March 8, 2008 Sponsor/Collaborators and Study Status
36 March 18, 2008 Contacts/Locations and Study Status
37 April 1, 2008 Study Status
38 April 30, 2008 Contacts/Locations and Study Status
39 May 23, 2008 Arms and Interventions and Study Status
40 July 23, 2008 Study Design and Study Status
41 October 2, 2008 Contacts/Locations and Study Status
42 February 6, 2009 Arms and Interventions and Study Status
43 May 28, 2009 Contacts/Locations and Study Status
44 June 25, 2009 Contacts/Locations and Study Status
45 September 22, 2009 References and Study Status
46 February 12, 2010 References and Study Status
47 January 6, 2011 Contacts/Locations and Study Status
48 May 19, 2011 Contacts/Locations and Study Status
49 August 5, 2011 Contacts/Locations and Study Status
50 February 29, 2012 Study Identification, Arms and Interventions, Contacts/Locations, Study Design, Sponsor/Collaborators, Study Status, Study Description, References, Eligibility, Outcome Measures and Oversight
51 March 12, 2012 Sponsor/Collaborators and Study Status
52 February 25, 2013 Arms and Interventions, Contacts/Locations, Study Status, Study Description, References, Eligibility, Study Design, Oversight and Study Identification
53 July 24, 2014 Arms and Interventions, Contacts/Locations, References, Study Description, Study Status, Eligibility, Study Design and Study Identification
54 September 21, 2017 Contacts/Locations, Arms and Interventions, Study Status, Outcome Measures, Eligibility, Study Description and Study Identification
55 March 23, 2018 Contacts/Locations, Arms and Interventions, Study Identification, Study Status, Outcome Measures, Study Design, Oversight, Eligibility, Conditions and Study Description
56 March 27, 2018 Arms and Interventions and Study Status
57 August 20, 2018 Study Status and Outcome Measures
58 August 22, 2018 Outcome Measures and Study Status
59 November 5, 2018 References, Study Status, Eligibility and Study Design
60 February 19, 2020 Study Status, Contacts/Locations and Arms and Interventions
61 November 9, 2020 Study Status, References, Contacts/Locations and Arms and Interventions
62 November 11, 2020 Eligibility and Study Status
63 April 5, 2022 Study Status and Outcome Measures
64 April 17, 2023 Recruitment Status, Study Status, Contacts/Locations and Study Design
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Study NCT00268476
Submitted Date:  December 20, 2005 (v1)

Open or close this module Study Identification
Unique Protocol ID: CDR0000455008
Brief Title: Androgen Suppression Alone or Combined With Zoledronate, Docetaxel, Prednisolone, and/or Celecoxib in Treating Patients With Locally Advanced or Metastatic Prostate Cancer
Official Title: Phase II/III Randomized Pilot Study of Androgen Suppression (AS) Alone Versus AS in Varying Combinations With Zoledronate, Docetaxel, Prednisolone, and/or Celecoxib in Patients With Locally Advanced or Metastatic Prostate Cancer
Secondary IDs: MRC-STAMPEDE
EU-205102
MRC-PR08
ISRCTN78818544
EUDRACT-2004-000193-31
Open or close this module Study Status
Record Verification: December 2005
Overall Status: Recruiting
Study Start:
Primary Completion:
Study Completion:
First Submitted: December 20, 2005
First Submitted that
Met QC Criteria:
December 20, 2005
First Posted: December 22, 2005 [Estimate]
Last Update Submitted that
Met QC Criteria:
December 20, 2005
Last Update Posted: December 22, 2005 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Medical Research Council
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
Brief Summary:

RATIONALE: Androgens can cause the growth of prostate cancer cells. Androgen suppression may stop the adrenal glands from making androgens. Zoledronate may stop the growth of tumor cells in bone and help relieve some of the symptoms caused by bone metastases. It may also delay or prevent bone metastases in patients with nonmetastatic prostate cancer. Drugs used in chemotherapy, such as docetaxel and prednisolone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking the blood flow to the tumor. It is not yet known whether giving androgen suppression together with zoledronate, docetaxel, prednisolone, and/or celecoxib is more effective than giving androgen suppression alone in treating prostate cancer.

PURPOSE: This randomized phase II/III trial is studying how well giving androgen suppression together with zoledronate, docetaxel, prednisolone, and/or celecoxib works and compares it to androgen suppression alone in treating patients with locally advanced or metastatic prostate cancer.

Detailed Description:

OBJECTIVES:

Primary

  • Compare the safety of androgen suppression (AS) alone vs AS in varying combinations with zoledronate, docetaxel, prednisolone, and celecoxib in patients with locally advanced or metastatic prostate cancer.
  • Compare failure-free survival and overall survival of patients treated with these regimens.

OUTLINE: This is a randomized, controlled, multicenter, pilot study. Patients are randomized to 1 of 6 treatment arms.

  • Arm I (androgen suppression [AS] only [control]): Patients undergo bilateral orchidectomy or receive luteinizing hormone-releasing hormone (LHRH) analogues to achieve castration levels of testosterone.
  • Arm II (AS and zoledronate): Patients undergo AS as in arm I. Patients also receive zoledronate IV over 15 minutes on day 1. Treatment repeats every 3 weeks for 6 courses and then every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
  • Arm III (AS, docetaxel, and prednisolone): Patients undergo AS as in arm I. Patients also receive docetaxel IV over 1 hour on day 1 and oral prednisolone twice daily on days 1-21. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
  • Arm IV (AS and celecoxib): Patients undergo AS as in arm I. Patients also receive oral celecoxib twice daily for 1 year in the absence of disease progression or unacceptable toxicity.
  • Arm V (AS, zoledronate, docetaxel, and prednisolone): Patients undergo AS as in arm I. Patients also receive zoledronate as in arm II and docetaxel and prednisolone as in arm III.
  • Arm VI (AS, zoledronate, and celecoxib): Patients undergo AS as in arm I. Patients also receive zoledronate as in arm II and celecoxib as in arm IV.

After completion of study treatment, patients are followed periodically thereafter.

PROJECTED ACCRUAL: Approximately 3,300 patients will be accrued for this study.

Open or close this module Conditions
Conditions: Stage III Prostate Cancer
Stage IV Prostate Cancer
Recurrent Prostate Cancer
Adenocarcinoma of the Prostate
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2/Phase 3
Interventional Study Model:
Number of Arms:
Masking: (masked roles unspecified)
Enrollment:
Open or close this module Arms and Interventions
Intervention Details:
Drug: celecoxib
Drug: docetaxel
Drug: prednisolone
Drug: zoledronate
Procedure: ablative endocrine surgery
Procedure: anti-cytokine therapy
Procedure: antiangiogenesis therapy
Procedure: biological response modifier therapy
Procedure: bone metastases prevention
Procedure: chemotherapy
Procedure: endocrine therapy
Procedure: enzyme inhibitor therapy
Procedure: growth factor antagonist therapy
Procedure: hormone therapy
Procedure: hypercalcemia therapy
Procedure: orchiectomy
Procedure: releasing factor agonist therapy
Procedure: supportive care/therapy
Open or close this module Outcome Measures
Open or close this module Eligibility
Minimum Age: 0 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

DISEASE CHARACTERISTICS:

  • Diagnosis of locally advanced or metastatic adenocarcinoma of the prostate, meeting 1 of the following criteria:
  • High risk newly diagnosed disease, meeting 1 of the following criteria:
  • Histologically confirmed T3-4, N0, M0 disease with prostate-specific antigen (PSA) ≥ 40 ng/mL or Gleason sum score 8-10
  • Histologically confirmed disease with any T, N+, M0 OR any T, any N, M+
  • Multiple sclerotic bone metastases with a PSA ≥ 100 ng/mL without histological confirmation
  • Histologically confirmed previously treated disease with radical surgery or radiotherapy that is now relapsing AND meets 1 of the following criteria:
  • PSA ≥ 4 ng/mL and rising with doubling time less than 6 months
  • PSA ≥ 20 ng/mL
  • Intention to treat with long-term androgen suppression
  • Testosterone normal (prior to the start of hormonal therapy)
  • No metastatic brain disease or leptomeningeal disease

PATIENT CHARACTERISTICS:

  • WHO performance status 0-2
  • Neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • ALT or AST ≤ 1.5 times upper limit of normal (ULN)
  • Bilirubin normal
  • Serum creatinine ≤ 1.5 times ULN
  • No renal insufficiency with estimated creatinine clearance < 30 mL/min
  • No severe congestive heart failure
  • No history of severe/unstable angina
  • No history of myocardial infarction
  • No history of New York Heart Association class II-IV severe cardiac failure
  • No history of cerebrovascular disease (e.g., stroke or transient ischemic episode)
  • No symptomatic peripheral neuropathy ≥ grade 2
  • No active peptic ulceration, gastrointestinal bleeding, or inflammatory bowel disease
  • No other previous or current malignant disease which, in the judgement of the responsible physician, is likely to interfere with study treatment or assessment
  • Willing and expected to comply with follow-up schedule

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Prior adjuvant or neoadjuvant hormonal therapy for localized disease must have been completed at least 12 months ago and have been no longer than 12 months in duration
  • No prior cyclooxygenase-2 inhibitor therapy that lasted ≥ 6 months prior to study entry
  • No surgery (e.g., transurethral resection of the prostate [TURP]) performed within the past 4 weeks
  • No prior systemic therapy for locally advanced or metastatic prostate cancer
  • No other concurrent cyclooxygenase-2 inhibitors
  • No concurrent participation in another clinical trial for prostate cancer
Open or close this module Contacts/Locations
Study Officials: Jacqueline Nuttal
Study Chair
Medical Research Council
Locations: United Kingdom, England
Queen Elizabeth Hospital at University of Birmingham
[Recruiting]
Birmingham, England, United Kingdom, B15 2TH
Contact:Contact: Nicholas D. James, MD 44-121-697-8314 n.d.james@bham.ac.uk
Castle Hill Hospital
[Recruiting]
Cottingham, England, United Kingdom, HU16 5JQ
Contact:Contact: J.W. Hetherington, MD 44-1482-622183 jwhurologist@yahoo.co.uk
Medical Research Council Clinical Trials Unit
[Recruiting]
London, England, United Kingdom, NW1 2DA
Contact:Contact: Jacqueline Nuttal 44-207-670-4831
Oxford Radcliffe Hospital
[Recruiting]
Oxford, England, United Kingdom, 0X3 9DU
Contact:Contact: Andrew Protheroe, MD 44-1865-226-183 kay.castle@cancer.org.uk
Salford Royal Hospitals NHS Trust
[Recruiting]
Salford, England, United Kingdom, M6 8HD
Contact:Contact: Noel Clarke 44-161-206-5568
Royal Hallamshire Hospital
[Recruiting]
Sheffield, England, United Kingdom, S1O 2JF
Contact:Contact: John Anderson 44-114-271-3482
Weston General Hospital
[Recruiting]
Sheffield, England, United Kingdom, S1O 2SJ
Contact:Contact: Peter Kirkbride, MD 44-114-226-5000 peter.kirkbride@sth.nhs.uk
Southampton General Hospital
[Recruiting]
Southampton, England, United Kingdom, SO16 6YD
Contact:Contact: Catherine Heath 44-23-8079-4202
Sunderland Royal Hospital
[Recruiting]
Sunderland, England, United Kingdom, SR4 7TP
Contact:Contact: Ian Pedley 44-191-256-3575
Royal Marsden NHS Foundation Trust - Surrey
[Recruiting]
Sutton, England, United Kingdom, SM2 5PT
Contact:Contact: David P. Dearnaley, MD, FRCP, FRCR 0208-661-3271
Torbay Hospital
[Recruiting]
Torquay Devon, England, United Kingdom, TQ2 7AA
Contact:Contact: Anna Lydon, MD 44-1803-655-376
United Kingdom, Northern Ireland
Belfast City Hospital Trust
[Recruiting]
Belfast, Northern Ireland, United Kingdom, BT9 7AB
Contact:Contact: Joe O'Sullivan 44-28-9026-3697 joe.osullivan@qub.ack.uk
United Kingdom, Scotland
Western General Hospital
[Recruiting]
Edinburgh, Scotland, United Kingdom, EH4 2XU
Contact:Contact: Duncan McLaren 44-131-537-5931
United Kingdom, Wales
Velindre Cancer Center at Velinde Hospital
[Recruiting]
Cardiff, Wales, United Kingdom, CF14 2TL
Contact:Contact: Malcolm D. Mason, MD 44-29-2031-6964 masonmd@cardiff.ac.uk
Singleton Hospital
[Recruiting]
Swansea, Wales, United Kingdom, SA 2 8QA
Contact:Contact: G. Bertelli 44-179-228-5826
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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