Phase II Study of Docetaxel for Clinically Asymptomatic High Risk Prostate Cancer Patients (TAX1)

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.

Study Overview

• Status: Terminated
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: Docetaxel

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.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 drugs.
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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Docetaxel; Docetaxel (Taxotere) 75 mg/m² IV every 3 weeks for 8 cycles.	Drug: Docetaxel; 75 mg/m2 iv every 3 weeks for 8 cycles; Other Names: Taxotere

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	3 to 6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
To evaluate the response rate to subsequent androgen deprivation therapy in patients not responding and in those having a biochemical recurrence after complete response.	3-6 months

Collaborators and Investigators

• Sponsor: CHU de Quebec-Universite Laval
• Investigators: Principal Investigator: Yves Fradet, MD, Centre hospitalier universitaire de Québec (CHUQ); Principal Investigator: Pierre Ouellet, MD, CHU de Quebec-Universite Laval

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (ACTUAL): July 1, 2008
• Study Completion (ACTUAL): July 1, 2008

Study Registration Dates

• First Submitted: July 10, 2008
• First Submitted That Met QC Criteria: July 10, 2008
• First Posted (ESTIMATE): July 14, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): October 31, 2012
• Last Update Submitted That Met QC Criteria: October 30, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: Docetaxel; Prostate cancer; Radical prostatectomy; Taxotere; High-risk prostate cancer; Early rising PSA
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Docetaxel
• Other Study ID Numbers: Project 5.2.08.02