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Prostate CancerPhase 2TAX1NCT00714376

Phase II Study of Docetaxel for Clinically Asymptomatic High Risk Prostate Cancer Patients

A Phase 2 study testing Docetaxel in people with Prostate Cancer, run by CHU de Quebec-Universite Laval at 1 site in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to assess the response to Taxotere (docetaxel) chemotherapy given as a primary treatment to patients with early and rapid PSA rising after prostatectomy for high risk disease. Read more about this study

Who is it for?
Ages 18 to 75 years, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Docetaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteCanada
Study dates
May 2008to Jul 2008
Phase
Phase 2
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 75 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of prostate adenocarcinoma on a radical prostatectomy.
  • Prior radical prostatectomy within less than 2 years from the time of first PSA rise.
  • Demonstration of biochemical recurrence based on a PSA detectable >0.03 less than 24 months after radical prostatectomy and confirmed on 2 additional tests.
  • PSA doubling time over three values must be <= 9 months for PSA >=0.4 and PSA <=10. If PSA is >10, there is no need for PSA doubling time.
  • Karnofsky performance status (KPS) >=70%
  • Adequate organ function as defined by hemogram with haemoglobin >8.0, platelet >100 000, white blood cell >3,500, creatinine clearance >=60 cc/min and normal liver function tests.
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  • Neoadjuvant hormone therapy prior to radical prostatectomy is allowed provided that the total duration of therapy did not exceed 6 months.
  • Subjects must have signed an informed consent document stating that they understand the investigational or nature of the proposed treatment.
  • Subjects must be willing and able to comply with scheduled visits, treatment plans, laboratory tests and other procedures.

Who cannot join

  • Clinical significant cardiac disease (New York Heart Association Class III/IV), or severe debilitating pulmonary disease.
  • Uncontrolled serious active infection.
  • Anticipated duration of life less than 2 years.
  • Less than 5-year history of successful treatment for other cancers or concurrent active non prostate cancer other than non melanoma dermatologic tumors and non-muscle invasive bladder tumors.
  • Peripheral neuropathy >=2 grade 2
  • Concurrent experimental treatment or involvement in other clinical trials involving drugs.
  • Other severe acute or chronic medical conditions including psychiatric diseases or significant laboratory abnormality requiring further investigation that may cause undue risk for the subject's safety.
  • Subjects who participated in another clinical study/received investigational product within 30 days of screening for this study.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Centre de recherche clinique et evaluative en oncologie, L'Hôtel-Dieu de Québec-CHUQ

    Québec, Quebec

Other trials in Canada

About this study

Official title: Phase II Single Center Study of Docetaxel for Clinically Asymptomatic High Risk Prostate Cancer Patients With an Early Rising PSA Following Radical Prostatectomy

The purpose of this study is to assess the response to Taxotere (docetaxel) chemotherapy given as a primary treatment to patients with early and rapid PSA rising after prostatectomy for high risk disease.

Read the detailed description

Patients with high-risk prostate cancer have a high probability of PSA failure after radical prostatectomy. However, more than half of these patients will remain free of PSA recurrence for more than 10 years. To the contrary, patients with early PSA recurrence and a doubling time less than 10 months have a mortality rate approaching 50% at 10 years despite hormone therapy. Although androgen deprivation therapy (ADT) remains the standard treatment for patients with early and rapidly rising PSA after prostatectomy, this treatment is not curative on the long term for most patients. The recent demonstration of activity of Taxotere (docetaxel) in a high proportion of patients with advanced metastatic disease has stimulated a great interest in it use at an earlier stage of the disease. Recent studies performed in animal models of prostate cancer suggested that the response rate of prostate cancer cells to docetaxel-induced cell death was significantly enhanced by androgen stimulation in AR-positive, androgen-dependent prostate cancer cells (i.e. before ADT). Therefore, this protocol proposes to assess the response rate to primary Taxotere chemotherapy in patients with early and rapid PSA rising after prostatectomy for high risk disease.

Conditions
Prostate Cancer
Being tested
Docetaxel
Keywords
Prostate cancer, High-risk prostate cancer, Radical prostatectomy, Early rising PSA, Taxotere, Docetaxel
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • DocetaxelDrug

    Also called Taxotere

    75 mg/m2 iv every 3 weeks for 8 cycles

Study groups in NCT00714376
Study groupRoleWhat they receive
DocetaxelExperimentalDocetaxel (Taxotere) 75 mg/m² IV every 3 weeks for 8 cycles.
Receives: Drug: Docetaxel

What is being measured

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

  1. To evaluate the rate of partial and complete biochemical response to 8 cycles of Taxotere in patients with early (<2 years) PSA recurrence after radical prostatectomy with a PSA doubling time of <=9 months.

    Measured: 3 to 6 months

Secondary outcomes (1)

  1. To evaluate the response rate to subsequent androgen deprivation therapy in patients not responding and in those having a biochemical recurrence after complete response.

    Measured: 3-6 months

Timeline

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

  1. First posted14 Jul 2008 (estimated)
  2. Study startMay 2008
  3. Primary completionJul 2008
  4. Study completionJul 2008

Why it stopped: Prematurely terminated due to financial considerations

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00714376
Sponsor's protocol ID
Project 5.2.08.02
Acronym
TAX1
Status last verified
Oct 2012
First submitted
10 Jul 2008
Last updated
31 Oct 2012
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Docetaxel in people with Prostate Cancer, run by CHU de Quebec-Universite Laval at 1 site in Canada.

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

Who may be eligible to take part?

The sponsor lists 9 inclusion and 8 exclusion criteria. 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: stopped early, as of the sponsor's last update on 31 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 was stopped early (reason given: Prematurely terminated due to financial considerations). Results are not available in the source record.

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?

To evaluate the rate of partial and complete biochemical response to 8 cycles of Taxotere in patients with early (<2 years) PSA recurrence after radical prostatectomy with a PSA doubling time of <=9 months. (time frame: 3 to 6 months). 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 NCT00714376.

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 31 Oct 2012.

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