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Docetaxel Compared With Observation in Treating Patients Who Have Undergone Radical Prostatectomy for Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Unknown status
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
docetaxel
active surveillance
adjuvant therapy
Sponsored by
Scandinavian Prostate Cancer Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, adenocarcinoma of the prostate

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the prostate meeting one of the following criteria after undergoing radical prostatectomy:

    • pT2 with Gleason score 4+3 or 8-10 and positive margins in the radical prostatectomy specimen
    • Any pT3a tumor with Gleason score ≥ 4+3
    • pT3b tumor with Gleason score ≥ 7
  • Negative lymph nodes at histological examination (N0)
  • Patients with a preoperative prostate-specific antigen (PSA) ≥ 10.0 ng/mL should have undergone a lymph node dissection
  • Postoperative PSA must be < 0.5 ng/mL
  • Considered at high risk for recurrent disease

  • No metastatic (M0) disease

    • Negative bone scan

PATIENT CHARACTERISTICS:

  • WHO/ECOG performance status 0-1
  • Hemoglobin ≥ 11.0 g/dL
  • Neutrophil count ≥ 1,500/mm³
  • Platelet count ≥ 150,000/mm³
  • Creatinine ≤ 1.5 times upper limit of normal (ULN)
  • Bilirubin normal
  • AST and ALT ≤ 1.5 times ULN
  • Alkaline phosphatase < 1.5 times ULN
  • No active untreated infectious disease (e.g., tuberculosis or methicillin-resistant Staphylococcus aureus)
  • No active gastric ulcer
  • No known hypersensitivity to polysorbate 80
  • No symptomatic peripheral neuropathy ≥ grade 2
  • No myocardial infarction within the past 6 months
  • No other unstable cardiovascular disease within the past 6 months
  • No other serious illness or medical condition
  • No altered psychological or physical state that would preclude study compliance
  • No other malignancy within the past 5 years except basal cell or squamous cell skin cancer

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior hormonal therapy (e.g., luteinizing hormone-releasing hormone analogues and/or antiandrogens) affecting prostate cancer cells
  • No prior radiotherapy to the pelvis
  • No prior chemotherapy
  • More than 6 months since prior systemic corticosteroids
  • No other concurrent anticancer therapy or investigational drugs

Sites / Locations

  • Aarhus Universitetshospital - Aarhus SygehusRecruiting
  • Copenhagen County Herlev University HospitalRecruiting
  • Tampere University HospitalRecruiting
  • Landspitalinn University HospitalRecruiting
  • Ullevaal University HospitalRecruiting
  • Norwegian University of Science and TechnologyRecruiting
  • Lund University HospitalRecruiting
  • Malmo University HospitalRecruiting

Outcomes

Primary Outcome Measures

Prostate-specific antigen (PSA) progression

Secondary Outcome Measures

PSA doubling time
Quality of Life
Metastasis-free survival
Overall survival

Full Information

First Posted
September 13, 2006
Last Updated
August 23, 2013
Sponsor
Scandinavian Prostate Cancer Group
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1. Study Identification

Unique Protocol Identification Number
NCT00376792
Brief Title
Docetaxel Compared With Observation in Treating Patients Who Have Undergone Radical Prostatectomy for Prostate Cancer
Official Title
An Open Randomized Phase III Trial of Six Cycles of Docetaxel Versus Surveillance After Radical Prostatectomy in High Grade Prostate Cancer Patients With Margin Positive T2 or T3 Tumours
Study Type
Interventional

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Unknown status
Study Start Date
October 2005 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Scandinavian Prostate Cancer Group

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving docetaxel after surgery may kill any tumor cells that remain after surgery. Sometimes, after surgery, the tumor may not need more treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether giving docetaxel after surgery is more effective than observation in treating prostate cancer. PURPOSE: This randomized phase III trial is studying docetaxel to see how well it works compared with observation in treating patients who have undergone radical prostatectomy for prostate cancer.
Detailed Description
OBJECTIVES: Primary Compare time to prostate-specific antigen (PSA) progression in patients with margin-positive tumors after undergoing radical prostatectomy for high-grade prostate cancer treated with docetaxel versus observation. Secondary Compare PSA doubling time in patients treated with these regimens. Compare quality of life of these patients. Compare overall and metastasis-free survival of patients treated with these regimens. OUTLINE: This is a prospective, open-label, randomized, multicenter study. Patients are stratified according to participating center and tumor stage (pT2 vs pT3). Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, directly after and 6 months after completing study treatment, and then annually thereafter. Arm II: Patients undergo observation until PSA progression (defined as PSA ≥ 0.5 ng/mL) Quality of life is assessed at baseline, week 19, and annually thereafter. After completion of study treatment, patients are followed periodically for 5 years. PROJECTED ACCRUAL: A total of 396 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, adenocarcinoma of the prostate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Masking
None (Open Label)
Allocation
Randomized
Enrollment
396 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
docetaxel
Intervention Type
Other
Intervention Name(s)
active surveillance
Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy
Primary Outcome Measure Information:
Title
Prostate-specific antigen (PSA) progression
Secondary Outcome Measure Information:
Title
PSA doubling time
Title
Quality of Life
Title
Metastasis-free survival
Title
Overall survival

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the prostate meeting one of the following criteria after undergoing radical prostatectomy: pT2 with Gleason score 4+3 or 8-10 and positive margins in the radical prostatectomy specimen Any pT3a tumor with Gleason score ≥ 4+3 pT3b tumor with Gleason score ≥ 7 Negative lymph nodes at histological examination (N0) Patients with a preoperative prostate-specific antigen (PSA) ≥ 10.0 ng/mL should have undergone a lymph node dissection Postoperative PSA must be < 0.5 ng/mL Considered at high risk for recurrent disease No metastatic (M0) disease Negative bone scan PATIENT CHARACTERISTICS: WHO/ECOG performance status 0-1 Hemoglobin ≥ 11.0 g/dL Neutrophil count ≥ 1,500/mm³ Platelet count ≥ 150,000/mm³ Creatinine ≤ 1.5 times upper limit of normal (ULN) Bilirubin normal AST and ALT ≤ 1.5 times ULN Alkaline phosphatase < 1.5 times ULN No active untreated infectious disease (e.g., tuberculosis or methicillin-resistant Staphylococcus aureus) No active gastric ulcer No known hypersensitivity to polysorbate 80 No symptomatic peripheral neuropathy ≥ grade 2 No myocardial infarction within the past 6 months No other unstable cardiovascular disease within the past 6 months No other serious illness or medical condition No altered psychological or physical state that would preclude study compliance No other malignancy within the past 5 years except basal cell or squamous cell skin cancer PRIOR CONCURRENT THERAPY: See Disease Characteristics No prior hormonal therapy (e.g., luteinizing hormone-releasing hormone analogues and/or antiandrogens) affecting prostate cancer cells No prior radiotherapy to the pelvis No prior chemotherapy More than 6 months since prior systemic corticosteroids No other concurrent anticancer therapy or investigational drugs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Goran Ahlgren, MD, PhD
Organizational Affiliation
Skane University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Per Flodgren, MD, PhD
Organizational Affiliation
Lund University Hospital
Facility Information:
Facility Name
Aarhus Universitetshospital - Aarhus Sygehus
City
Aarhus
ZIP/Postal Code
DK 8200
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Borre, MD, PhD, DMsci
Phone
45-89-495-566
Facility Name
Copenhagen County Herlev University Hospital
City
Copenhagen
ZIP/Postal Code
DK-2730
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa Sengelov, MD, PhD
Phone
45-44-884-488
Email
lise@herlevhosp.kbhamt.dk
Facility Name
Tampere University Hospital
City
Tampere
ZIP/Postal Code
33521
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pirkko Kellokumpu-Lehtinen
Phone
358-3-247-3227
Email
pirkko-liisa.kellokumpu-lehtinen@uta.fi
Facility Name
Landspitalinn University Hospital
City
Reykjavik
ZIP/Postal Code
125
Country
Iceland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Asgerdur Sverrisdottir, MD
Phone
354-543-1000
Email
asgerds@landspitali.is
Facility Name
Ullevaal University Hospital
City
Oslo
ZIP/Postal Code
0407
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jon R. Iversen, MD
Phone
47-22-119-310
Email
joiv@uus.no
Facility Name
Norwegian University of Science and Technology
City
Trondheim
ZIP/Postal Code
N-7005
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anders Angelsen, MD, PhD
Phone
47-73-868-000
Facility Name
Lund University Hospital
City
Lund
ZIP/Postal Code
SE-22185
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Per Flodgren, MD, PhD
Phone
46-46-177-520
Facility Name
Malmo University Hospital
City
Malmo
ZIP/Postal Code
S-20502
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Goran Ahlgren, MD, PhD
Phone
46-40-33-3754
Email
goran.ahlgren@skane.se

12. IPD Sharing Statement

Learn more about this trial

Docetaxel Compared With Observation in Treating Patients Who Have Undergone Radical Prostatectomy for Prostate Cancer

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