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

Primary Purpose

Prostate Cancer

Status

Terminated

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

Docetaxel

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate cancer, High-risk prostate cancer, Radical prostatectomy, Early rising PSA, Taxotere, Docetaxel

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

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.
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.

Exclusion Criteria:

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Docetaxel

Arm Description

Docetaxel (Taxotere) 75 mg/m² IV every 3 weeks for 8 cycles.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00714376

First Posted

July 10, 2008

Last Updated

October 30, 2012

Sponsor

CHU de Quebec-Universite Laval

1. Study Identification

Unique Protocol Identification Number

NCT00714376

Brief Title

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

Acronym

TAX1

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2012

Overall Recruitment Status

Terminated

Why Stopped

Prematurely terminated due to financial considerations

Study Start Date

May 2008 (undefined)

Primary Completion Date

July 2008 (Actual)

Study Completion Date

July 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

CHU de Quebec-Universite Laval

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

Prostate cancer, High-risk prostate cancer, Radical prostatectomy, Early rising PSA, Taxotere, Docetaxel

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Docetaxel

Arm Type

Experimental

Arm Description

Docetaxel (Taxotere) 75 mg/m² IV every 3 weeks for 8 cycles.

Intervention Type

Drug

Intervention Name(s)

Docetaxel

Other Intervention Name(s)

Taxotere

Intervention Description

75 mg/m2 iv every 3 weeks for 8 cycles

Primary Outcome Measure Information:

Title

Time Frame

3 to 6 months

Secondary Outcome Measure Information:

Title

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

Time Frame

3-6 months

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yves Fradet, MD

Organizational Affiliation

Centre Hospitalier Universitaire de Quebec (CHUQ)

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Pierre Ouellet, MD

Organizational Affiliation

CHU de Quebec-Universite Laval

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Quebec

Country

Canada

12. IPD Sharing Statement

Learn more about this trial

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

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