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Radical Prostatectomy for Locally Advanced Prostate Cancer. A Feasibility Study


Phase 2
N/A
70 Years
Not Enrolling
Male
Prostate Cancer

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Trial Information

Radical Prostatectomy for Locally Advanced Prostate Cancer. A Feasibility Study


OBJECTIVES:

- Determine the success rate of radical prostatectomy in patients with locally advanced
adenocarcinoma of the prostate.

- Determine the serious toxic event rate of this surgery in these patients.

- Determine the pN status of patients treated with this surgery.

- Determine the percentage of patients found to have organ-confined tumors (pT2) after
undergoing this surgery.

- Determine the 2-year prostate-specific antigen-free survival rate of patients treated
with this surgery.

- Determine the surgical morbidity rates of patients treated with this surgery.

OUTLINE: This is a multicenter study.

Patients undergo limited pelvic lymphadenectomy and then radical retropubic prostatectomy.

Patients who are found to have pN-positive disease receive further treatment according to
the investigator's discretion. Patients with pN0 disease are followed every 3 months for 1
year and then every 4 months for 1 year.

PROJECTED ACCRUAL: A total of 32-74 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed adenocarcinoma of the prostate

- Unilateral cT3a, cN0, M0

- Well or moderately differentiated tumor

- Gleason score no greater than 7 (4 plus 3 or 3 plus 4)

- Total serum prostate-specific antigen no greater than 20 ng/mL (Hybritech equivalent)

PATIENT CHARACTERISTICS:

Age:

- 70 and under

Performance status:

- WHO 0-1

Life expectancy:

- Not specified

Hematopoietic:

- WBC greater than 3,000/mm^3

- Platelet count greater than 100,000/mm^3

- Hemoglobin greater than 9 g/dL

Hepatic:

- Bilirubin no greater than 1.5 times normal

- ALT or AST less than 3 times normal

- PT and PTT normal

Renal:

- Creatinine no greater than 1.5 mg/dL

Cardiovascular:

- No preexisting uncontrolled cardiac disease, signs of cardiac failure, or rhythm
disturbances requiring therapy

- No myocardial infarction within the past 6 months

Pulmonary:

- No gross abnormalities on chest x-ray

Other:

- No other disease that would preclude surgery

- No other prior malignancy except adequately treated basal cell skin cancer

- No other concurrent primary malignancy

- No psychological, familial, sociological, or geographical condition that would
preclude compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- Not specified

Endocrine therapy:

- No prior hormonal therapy that would affect assessment of clinical T staging, margin
positivity, or definitive pT staging

Radiotherapy:

- No prior pelvic radiotherapy that would affect surgical resectability and
perioperative morbidity

Surgery:

- No prior surgery in the small pelvis (vascular surgery, mesh graft hernia repair, any
surgery for benign prostatic hypertrophy, or transurethral resection of prostate)
that would preclude prostatectomy

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Hein van Poppel, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

U.Z. Gasthuisberg

Authority:

United States: Federal Government

Study ID:

EORTC-30001

NCT ID:

NCT00027794

Start Date:

September 2001

Completion Date:

Related Keywords:

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

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