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Prostate CancerPhase 3NCT00255606

Docetaxel and Prednisone in Treating Patients With Hormone-Refractory Metastatic Prostate Cancer

A Phase 3 study testing docetaxel and prednisone in people with Prostate Cancer, run by Tampere University at 19 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
docetaxel and prednisone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
360 participants
Where
19 sitesin 3 countries
Study dates
Aug 2005to Aug 2010
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 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed adenocarcinoma of the prostate
  • Metastatic disease by imaging or clinical examination
  • Hormone-refractory disease, defined as prostate-specific antigen (PSA) level > 10 µg/L AND rising between 2 sequential measurements
  • Testosterone within castration levels by orchiectomy or medical castration comprising luteinizing hormone-releasing hormone (LHRH) analogues

PATIENT CHARACTERISTICS:

Age

  • Over 18

Performance status

  • WHO 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Neutrophil count ≥ 1,500/mm^3
  • Hemoglobin ≥ 11.0 g/dL
  • Platelet count ≥ 100,000/mm^3

Hepatic

  • ALT and AST ≤ 2.5 times upper limit of normal (ULN)
  • Bilirubin normal
  • Alkaline phosphatase ≤ 6 times ULN (unless due to the presence of extensive bone disease)
  • No serious liver disease

Renal

  • Creatinine ≤ 1.5 times ULN

Cardiovascular

  • No ischemic or thromboembolic cardiac disease
  • No myocardial infarction within the past 12 months
  • No other serious cardiac disease

Pulmonary

  • No pulmonary emboli

Immunologic

  • No active infection
  • No autoimmune disease, including any of the following:
  • Lupus
  • Scleroderma
  • Rheumatoid polyarthritis

Other

  • No active peptic ulcer
  • No unstable diabetes mellitus
  • No contraindication to corticosteroids
  • No other malignant disease within the past 5 years except basalioma
  • No functional iron deficiency (i.e., transferrin saturation < 20%) that cannot be treated with iron supplementation
  • No other serious illness or medical condition

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • More than 2 months since prior recombinant human epoetin alfa or any other erythropoiesis-stimulating drug

Chemotherapy

  • At least 3 weeks since prior estramustine

Endocrine therapy

  • See Disease Characteristics
  • At least 3 weeks since prior antiandrogen treatment
  • Concurrent chemical castration with LHRH allowed provided patient has begun treatment prior to study entry
  • No initiation of chemical castration therapy during study treatment

Radiotherapy

  • No prior radiotherapy to > 25% of bone marrow
  • No prior radioisotope therapy
  • Concurrent local palliative radiotherapy for pain allowed

Surgery

  • See Disease Characteristics
  • At least 4 weeks since prior surgery

Other

  • No other prior cytostatic treatment
  • Concurrent bisphosphonates allowed provided patient has begun treatment prior to study entry
  • No initiation of bisphosphonates during study treatment

Trial locations and contacts

19 sites in 3 countries.

19 sites in 3 countries

Finland9 sites

  • Helsinki University Central Hospital

    Helsinki, FIN-00029

  • Kainuu Central Hospital

    Kajaani, 87140

  • Keski-Pohjanmaa Central Hospital

    Kokkola, 67200

  • Kymenlaakso Central Hospital

    Kotka, 48210

  • Tampere University Hospital

    Lahti, 15850

  • Oulu University Hospital

    Oulu, FIN-90014

  • Satakunta Central Hospital

    Pori, 28500

  • Tampere University Hospital

    Tampere, 33521

  • Turku University Central Hospital

    Turku, FIN-20521

Other trials in Finland

Ireland8 sites

  • Bons Secours Hospital

    Cork

  • Mercy University Hospital

    Cork

  • Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital

    Dublin, 24

  • Mater Misericordiae University Hospital

    Dublin, 7

  • St. James's Hospital

    Dublin, 8

  • Beaumont Hospital

    Dublin, 9

  • Galway University Hospital

    Galway

  • Mid-Western Cancer Centre at Mid-Western Regional Hospital

    Limerick, 0009

Other trials in Ireland

Sweden2 sites

  • Karlstad Central Hospital

    Karlstad, 65185

  • Karolinska University Hospital - Solna

    Stockholm, S-171 76

Other trials in Sweden

About this study

Official title: A Phase III Trial Comparing Docetaxel Every Third Week to Biweekly Docetaxel Monotherapy in Metastatic Hormone Refractory Prostate Cancer Patients - PROSTY Trial

RATIONALE: Drugs used in chemotherapy, such as docetaxel and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known which schedule of docetaxel and prednisone is more effective in treating prostate cancer.

PURPOSE: This randomized phase III trial is studying two different schedules of docetaxel and prednisone to compare how well they work in treating patients with metastatic prostate cancer.

Read the detailed description

OBJECTIVES:

Primary

  • Compare the time to treatment failure in patients with hormone-refractory metastatic prostate cancer treated with two different schedules of docetaxel in combination with prednisone.

Secondary

  • Compare overall survival of patients treated with these regimens.
  • Compare the response rate in patients treated with these regimens.
  • Compare the safety of these regimens in these patients.
  • Compare the quality of life of patients treated with these regimens.
  • Compare the need for epoetin beta in patients treated with these regimens.
  • Determine the effect of epoetin beta on hemoglobin response rate, transfusion rate, and quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, controlled, multicenter study. Patients are stratified according to participating center and WHO performance status (0-1 vs 2). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive docetaxel IV over 1 hour on days 1 and 15 and oral prednisone once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients receive docetaxel IV over 1 hour on day 1 and prednisone once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients who experience anemia (hemoglobin < 11 g/dL) receive epoetin beta subcutaneously once weekly during chemotherapy.

Quality of life is assessed at baseline, every 6 weeks during study treatment, at completion of study treatment, and then every 2 months thereafter.

After completion of study treatment, patients are followed every 2 months.

PROJECTED ACCRUAL: A total of 360 patients (180 per treatment arm) will be accrued for this study within 4 years.

Conditions
Prostate Cancer
Being tested
docetaxel, prednisone
Keywords
adenocarcinoma of the prostate, stage IV prostate cancer, recurrent prostate cancer
Medical subject headings
Prostatic Neoplasms

What participants receive

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

Study groups in NCT00255606
Study groupRoleWhat they receive
Arm IExperimentalPatients receive docetaxel IV over 1 hour on days 1 and 15 and oral prednisone once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Receives: Drug: docetaxel; Drug: prednisone
Arm IIExperimentalPatients receive docetaxel IV over 1 hour on day 1 and prednisone once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Receives: Drug: docetaxel; Drug: prednisone

What is being measured

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

  1. Time to treatment failure (TTF)

Secondary outcomes (5)

  1. Quality of life every 6 weeks until TTF

  2. Safety

  3. Overall survival

  4. Response rate

  5. Use of epoetin beta

Timeline

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

  1. First posted21 Nov 2005 (estimated)
  2. Study startAug 2005
  3. Primary completionMay 2009
  4. Study completionAug 2010

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
Enrolment
360 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00255606
Sponsor's protocol ID
AVENTIS-FIN-1-2003
Other IDs
CDR0000442891, FINNISH-URO-OGS-1-2003, PROSTY-FIN-1-2003, ICORG-06-14-Prosty, EU-20891
Status last verified
Sep 2010
First submitted
18 Nov 2005
Last updated
26 Jun 2013
Results posted
No

Publications

  • Kellokumpu-Lehtinen PL, Harmenberg U, Joensuu T, McDermott R, Hervonen P, Ginman C, Luukkaa M, Nyandoto P, Hemminki A, Nilsson S, McCaffrey J, Asola R, Turpeenniemi-Hujanen T, Laestadius F, Tasmuth T, Sandberg K, Keane M, Lehtinen I, Luukkaala T, Joensuu H; PROSTY study group. 2-Weekly versus 3-weekly docetaxel to treat castration-resistant advanced prostate cancer: a randomised, phase 3 trial. Lancet Oncol. 2013 Feb;14(2):117-24. doi: 10.1016/S1470-2045(12)70537-5. Epub 2013 Jan 4.

    PubMed 23294853

  • Hervonen P, Joensuu H, Joensuu T, Ginman C, McDermott R, Harmenberg U, Nyandoto P, Luukkaala T, Hemminki A, Zaitsev I, Heikkinen M, Nilsson S, Luukkaa M, Lehtinen I, Kellokumpu-Lehtinen PL. Biweekly docetaxel is better tolerated than conventional three-weekly dosing for advanced hormone-refractory prostate cancer. Anticancer Res. 2012 Mar;32(3):953-6.

    PubMed 22399616

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing docetaxel and prednisone in people with Prostate Cancer, run by Tampere University at 19 sites in 3 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: finished, as of the sponsor's last update on 26 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in Finland, Ireland, Sweden. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to treatment failure (TTF). 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 NCT00255606, which also lists 2 linked publications.

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 Jun 2013.

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