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

Phase 2
18 Years
75 Years
Not Enrolling
Prostate Cancer

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Trial Information

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

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

Inclusion Criteria:

1. Diagnosis of prostate adenocarcinoma on a radical prostatectomy.

2. Prior radical prostatectomy within less than 2 years from the time of first PSA rise.

3. Demonstration of biochemical recurrence based on a PSA detectable >0.03 less than 24
months after radical prostatectomy and confirmed on 2 additional tests.

4. 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.

5. Karnofsky performance status (KPS) >=70%

6. 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.

7. Neoadjuvant hormone therapy prior to radical prostatectomy is allowed provided that
the total duration of therapy did not exceed 6 months.

8. Subjects must have signed an informed consent document stating that they understand
the investigational or nature of the proposed treatment.

9. Subjects must be willing and able to comply with scheduled visits, treatment plans,
laboratory tests and other procedures.

Exclusion Criteria:

1. Clinical significant cardiac disease (New York Heart Association Class III/IV), or
severe debilitating pulmonary disease.

2. Uncontrolled serious active infection.

3. Anticipated duration of life less than 2 years.

4. 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.

5. Peripheral neuropathy >=2 grade 2

6. Concurrent experimental treatment or involvement in other clinical trials involving

7. 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.

8. Subjects who participated in another clinical study/received investigational product
within 30 days of screening for this study.

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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.

Outcome Time Frame:

3 to 6 months

Safety Issue:


Principal Investigator

Yves Fradet, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre Hospitalier Universitaire de Quebec (CHUQ)


Canada: Health Canada

Study ID:




Start Date:

May 2008

Completion Date:

July 2008

Related Keywords:

  • Prostate Cancer
  • Prostate cancer
  • High-risk prostate cancer
  • Radical prostatectomy
  • Early rising PSA
  • Taxotere
  • Docetaxel
  • Prostatic Neoplasms