|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
6 May 2013 |
|
Main ID: |
NCT00321698 |
|
Date of registration:
|
02/05/2006 |
|
Primary sponsor: |
|
|
Public title:
|
Radiation Therapy and Docetaxel in Treating Patients Who Are Undergoing Surgery for Localized Prostate Cancer
|
|
Scientific title:
|
Phase I/II Study of Preoperative Radiation and Docetaxel Activity in High Risk Localized Prostate Cancer |
|
Date of first enrolment:
|
January 2006 |
|
Target sample size:
|
25 |
|
Recruitment status: |
Active, not recruiting |
|
URL:
|
http://clinicaltrials.gov/show/NCT00321698 |
|
Study type:
|
Interventional |
|
Study design:
|
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Mark Garzotto, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
OHSU Knight Cancer Institute |
| | |
|
Key inclusion & exclusion criteria
|
DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the prostate
- Localized disease, meeting 1 of the following staging criteria:
- Clinical stage T2b (palpable bilateral movement) disease
- Surgically resectable T3 disease
- Meets any of the following high-risk* features:
- PSA = 15 ng/mL
- Gleason grade = 4+3 (4+3, 4+4, or 5+any, but not 3+4) NOTE: *High risk defined
as > 50% chance of failure with local therapy
- Plans to undergo prostatectomy as primary therapy
- No evidence of lymph nodes = 2 cm in diameter by pelvic CT scan
- Scan only required in patients with a PSA = 40 ng/mL
- No evidence of bone metastases by bone scan
PATIENT CHARACTERISTICS:
- Life expectancy = 10 years
- ECOG performance status 0-2
- WBC > 3,000/mm^3
- Neutrophil count > 1,500/mm^3
- Platelet count > 100,000/mm^3
- Direct bilirubin normal
- ALT < 2.0 times upper limit of normal (ULN) (1.5 times ULN if alkaline phosphatase
[AP] > 2.5 times ULN)
- AP < 4.0 times ULN
- No other serious medical condition that would preclude study treatment
- No other malignancy within the past 5 years except nonmelanoma skin cancer
- No peripheral neuropathy = grade 2
- No hypersensitivity to drugs formulated with polysorbate 80
- No significant contraindications to corticosteroids
- No history of scleroderma
- No active inflammatory bowel disease (IBD) or IBD that is being medically treated
- Inclusion of patients with a remote history of IBD is at the discretion of
radiotherapist
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior therapy for prostate cancer, including any of the following:
- Conventional hormonal therapy (e.g., orchiectomy, luteinizing hormone-releasing
hormone therapy, antiandrogen therapy, or estrogen therapy)
- External-beam radiotherapy or brachytherapy
- Cryotherapy
- Cytotoxic chemotherapy
- No prior pelvic radiotherapy
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Male
|
|
Health Condition(s) or Problem(s) studied
|
|
Prostate Cancer
|
|
Intervention(s)
|
|
Drug: docetaxel
|
|
Radiation: radiation therapy
|
|
Primary Outcome(s)
|
|
Maximum tolerated dose
[Time Frame: Between treatment groups]
|
|
Pathologic response rate at the phase II dose
[Time Frame: End of treatment]
|
|
Secondary Outcome(s)
|
|
Clinical progression-free rate
[Time Frame: Regular intervals]
|
|
Clinical response to treatment as measured by urologic examination
[Time Frame: Regular intervals]
|
|
Correlative serum biomarkers following study completion
[Time Frame: Data analysis]
|
|
Efficacy assessed using Health-Related Quality of Life by Expanded Prostate Cancer Index Composite and urinary symptom scores by American Urological Association's measures
[Time Frame: Regular intervals]
|
|
Long-term safety
[Time Frame: Regular intervals]
|
|
Molecular impact by RNA content (gene expression profile) compared before and after treatment
[Time Frame: Data analysis]
|
|
Prostate-specific antigen short-term response rate
[Time Frame: Regular intervals]
|
|
Response by assessing biologic markers in tissue and serum before treatment
[Time Frame: Data analysis]
|
|
Surgical margin status at time of prostatectomy
[Time Frame: End of treatment]
|
|
Secondary ID(s)
|
|
CDR0000467219
|
|
IIT16179
|
|
OHSU-1581
|
|
OHSU-SOL-05077-L
|
|
PVAMC-11-1205/ M1675
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|