AzTrials
AzTrials

Prostate CancerPhase 3NCT00376792

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

A Phase 3 study testing docetaxel, active surveillance and adjuvant therapy in people with Prostate Cancer, run by Scandinavian Prostate Cancer Group at 8 sites in 5 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years, men only
Conditions the study is for
Prostate Cancer
What is being tested?
docetaxel, active surveillance and adjuvant therapy
Type of treatment
Surgery or procedure
How many people
396 participants
Where
8 sitesin 5 countries
Study dates
Oct 2005to Dec 2012
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

8 sites in 5 countries.

8 sites in 5 countries

Denmark2 sites, 2 recruiting

  • Aarhus Universitetshospital - Aarhus Sygehus

    Aarhus, DK 8200

    Michael Borre, MD, PhD, DMsci, 45-89-495-566

    Recruiting

  • Copenhagen County Herlev University Hospital

    Copenhagen, DK-2730

    Lisa Sengelov, MD, PhD, 45-44-884-488, lise@herlevhosp.kbhamt.dk

    Recruiting

Other trials in Denmark

Norway2 sites, 2 recruiting

  • Ullevaal University Hospital

    Oslo, 0407

    Jon R. Iversen, MD, 47-22-119-310, joiv@uus.no

    Recruiting

  • Norwegian University of Science and Technology

    Trondheim, N-7005

    Anders Angelsen, MD, PhD, 47-73-868-000

    Recruiting

Other trials in Norway

Sweden2 sites, 2 recruiting

  • Lund University Hospital

    Lund, SE-22185

    Per Flodgren, MD, PhD, 46-46-177-520

    Recruiting

  • Malmo University Hospital

    Malmö, S-20502

    Goran Ahlgren, MD, PhD, 46-40-33-3754, goran.ahlgren@skane.se

    Recruiting

Other trials in Sweden

Finland1 site, 1 recruiting

  • Tampere University Hospital

    Tampere, 33521

    Pirkko Kellokumpu-Lehtinen, 358-3-247-3227, pirkko-liisa.kellokumpu-lehtinen@uta.fi

    Recruiting

Other trials in Finland

Iceland1 site, 1 recruiting

  • Landspitalinn University Hospital

    Reykjavik, 125

    Asgerdur Sverrisdottir, MD, 354-543-1000, asgerds@landspitali.is

    Recruiting

Other trials in Iceland

About this study

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

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.

Read the 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.

Conditions
Prostate Cancer
Being tested
docetaxel, active surveillance, adjuvant therapy
Keywords
stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, adenocarcinoma of the prostate
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prostate-specific antigen (PSA) progression

Secondary outcomes (4)

  1. PSA doubling time

  2. Quality of Life

  3. Metastasis-free survival

  4. Overall survival

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2006 (estimated)
  2. Study startOct 2005
  3. Primary completionDec 2012 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Masking
None (open label)
Enrolment
396 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00376792
Sponsor's protocol ID
CDR0000456773
Other IDs
SPCG-12, EUDRACT-2005-002355-40, EU-20638, SANOFI-AVENTIS-SPCG-12, SPCG-ADPRO
Status last verified
Jun 2009
First submitted
13 Sep 2006
Last updated
26 Aug 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing docetaxel, active surveillance and adjuvant therapy in people with Prostate Cancer, run by Scandinavian Prostate Cancer Group at 8 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Denmark, Norway, Sweden, Finland, Iceland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prostate-specific antigen (PSA) progression. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00376792.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2013.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in