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Phase I/II Study of Preoperative Radiation and Docetaxel Activity in High Risk Localized Prostate Cancer

Phase 1/Phase 2
18 Years
Open (Enrolling)
Prostate Cancer

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Trial Information

Phase I/II Study of Preoperative Radiation and Docetaxel Activity in High Risk Localized Prostate Cancer



- Determine the maximum tolerated dose (MTD) of neoadjuvant radiotherapy and docetaxel in
patients who are undergoing prostatectomy for high-risk localized prostate cancer.

- Determine the pathologic response rate in patients treated at the phase II dose.


- Determine the prostate-specific antigen (PSA) short-term response rate in patients
treated with this regimen.

- Determine the long-term safety of this regimen prior to radical prostatectomy in these

- Determine the clinical response to this regimen by urologic examination of these

- Determine the surgical margin status at the time of prostatectomy in patients treated
with this regimen.

- Determine the effect of this regimen, in terms of Health-Related Quality of Life by
Expanded Prostate Cancer Index Composite (EPIC) and urinary symptom scores by the
American Urological Association's measures, in these patients.

- Determine the clinical progression-free rate in patients treated with this regimen.

- Identify pretreatment predictors of response in these patients by examining tissue
biomarkers in preserved pretreatment biopsy specimens.

- Determine the biologic impact of this regimen on these patients by examining the
prostatectomy specimens.

- Collect frozen serum for future analysis of correlative biomarkers.

- Compare the RNA content (gene expression profile) of pre- and post-treatment tumor
specimens in order to describe the molecular impact of this regimen on prostate cancer.

OUTLINE: This is a phase I, dose-escalation study of docetaxel followed by a phase II study.
All patients undergo a biopsy of the prostate to gather research-only specimens prior to the
beginning of treatment.

- Phase I: Patients undergo radiotherapy once daily, 5 days a week, for 5 weeks. Patients
also receive docetaxel IV on days 1, 8, 15, 22, and 29. Treatment continues in the
absence of disease progression or unacceptable toxicity. Approximately 4-6 weeks after
completion of chemoradiotherapy, patients undergo a radical prostatectomy.

Cohorts of 3-6 patients receive escalating doses of docetaxel until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2
of 6 patients experience a dose-limiting toxicity. At least 6 patients are treated at the

- Phase II: Patients undergo radiotherapy as in phase I. Patients also receive docetaxel
at the MTD determined in phase I and then undergo prostatectomy as in phase I.

PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study.

Inclusion Criteria


- 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


- 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


- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose

Outcome Time Frame:

Between treatment groups

Safety Issue:


Principal Investigator

Mark Garzotto, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

OHSU Knight Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

January 2006

Completion Date:

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • stage II prostate cancer
  • stage III prostate cancer
  • Prostatic Neoplasms



Veterans Affairs Medical Center - Portland Portland, Oregon  97207
OHSU Knight Cancer Institute Portland, Oregon  97239