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Phase III Randomized Study of Adjuvant Therapy for High Risk pT3N0 Prostate Cancer


Phase 3
N/A
N/A
Not Enrolling
Male
Prostate Cancer

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Trial Information

Phase III Randomized Study of Adjuvant Therapy for High Risk pT3N0 Prostate Cancer


OBJECTIVES:

- Compare the overall survival, disease-free survival, freedom from distant metastases,
and freedom from PSA failure in patients with high-risk stage II or III prostate cancer
treated in the adjuvant setting with radiotherapy and hormonal therapy vs radiotherapy
alone.

- Compare the qualitative and quantitative toxic effects of these regimens in these
patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
seminal vesicle invasion (yes vs no), preoperative PSA (10 ng/mL or less vs greater than 10
ng/mL), Gleason score (2-6 vs 7 vs 8-10), positive surgical margins (yes vs no), and
neoadjuvant hormonal therapy (yes vs no). Patients are randomized to 1 of 3 treatment arms.
(Arm III closed to accrual as of 12/9/2002.)

- Arm I: Patients undergo radiotherapy once daily 5 days a week for 7 weeks. Beginning
the first day of radiotherapy, patients also receive hormonal therapy comprising a
luteinizing-hormone-releasing hormone agonist once every 1-4 months for 2 years AND
oral flutamide 3 times daily OR oral bicalutamide once daily for 1 month.

- Arm II: Patients undergo radiotherapy as in arm I.

- Arm III (Closed to accrual as of 12/9/2002):Patients receive hormonal therapy as in arm
I.

Patients are followed every 3 months for 1 year, every 6 months for 4 years, and then
annually thereafter.

PROJECTED ACCRUAL: A total of 1,398 patients (699 per treatment arm) will be accrued for
this study within 5 years. (Arm III closed to accrual as of 12/9/2002.)

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed prostate cancer

- T2-3, N0, M0

- No metastatic disease

- High-risk for PSA relapse as defined by Gleason score 7 or higher and ≥ 1 of the
following OR Gleason score < 7 and ≥ 2 of the following:

- Preoperative PSA > 10 ng/mL

- Positive surgical margins

- Seminal vesicle invasion

- Preoperative PSA ≤ 40.0 ng/mL

- Postoperative PSA ≤ 0.2 ng/mL

- Negative lymph node status by lymph node sampling or dissection

- If lymph node status is unknown, must have < 5% risk of involvement by Roach
formula

PATIENT CHARACTERISTICS:

Age:

- Not specified

Performance status:

- Zubrod 0-1

Life expectancy:

- Not specified

Hematopoietic:

- WBC ≥ 3,000/mm^3

- Platelet count ≥ 130,000/mm^3

- Hemoglobin ≥ 11.4 g/dL

Hepatic:

- ALT ≤ 3 times normal

Renal:

- Creatinine ≤ 2.5 mg/dL

Other:

- No other prior or concurrent invasive malignancy within the past 5 years except
superficial nonmelanoma skin cancer

- No other major medical or psychiatric illness that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- At least 5 years since prior chemotherapy

Endocrine therapy:

- At least 60 days since prior finasteride

- At least 90 days since prior testosterone

- Prior pharmacologic androgen ablation for prostate cancer allowed if initiated within
the past 10 months (must switch to study ablation therapy OR discontinue therapy if
randomized to receive radiotherapy only)

Radiotherapy:

- No prior radiotherapy to the pelvis

- No concurrent intensity-modulated radiotherapy

Surgery:

- No prior orchiectomy

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Richard K. Valicenti, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Kimmel Cancer Center (KCC)

Authority:

United States: Federal Government

Study ID:

CDR0000068868

NCT ID:

NCT00023829

Start Date:

August 2001

Completion Date:

Related Keywords:

  • Prostate Cancer
  • stage III prostate cancer
  • stage IIB prostate cancer
  • stage IIA prostate cancer
  • Prostatic Neoplasms

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