Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Related Information
Registry Information

Alternate Title

Hormone Therapy and Radiation Therapy or Hormone Therapy and Radiation Therapy Followed by Docetaxel and Prednisone in Treating Patients With Localized Prostate Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	18 and over	NCI	RTOG-0521 NCT00288080

Special Category: NCI Web site featured trial, CTSU trial

Objectives

Primary

1. Compare the relative efficacy, in terms of overall survival, of the combination of androgen suppression and radiotherapy versus androgen suppression and radiotherapy followed by docetaxel and prednisone in patients with localized, high-risk prostate cancer.

Secondary

1. Compare the disease-free survival and incidence of adverse events in patients treated with these regimens.
2. Compare the biochemical control, local control, and freedom from distant metastases in patients treated with these regimens.
3. Determine the validity of prostate-specific antigen (PSA)-defined endpoints as a surrogate for overall survival of patients treated with these regimens.
4. Compare the time interval between biochemical failure and distant metastases with respect to testosterone level in patients treated with these regimens.

Entry Criteria

Disease Characteristics:

• Histologically confirmed prostate cancer at high-risk for recurrence within the past 180 days as determined by 1 of the following combinations (risk groups):
  • Gleason score ≥ 9, prostate-specific antigen (PSA) ≤ 150 ng/mL, and any T stage
  • Gleason score 8, PSA < 20 ng/mL, and stage ≥ T2
  • Gleason score 8, PSA 20-150 ng/mL, and any T stage
  • Gleason score 7, PSA 20-150 ng/mL, and any T stage
• Clinically negative lymph nodes by imaging (pelvic CT scan or pelvic MRI), nodal sampling, or dissection within 90 days prior to study entry
  • Equivocal or questionable lymph nodes ≤ 1.5 cm by imaging allowed
  • Positive lymph nodes by capromab pendetide (ProstaScint^®) scan with a corresponding lymph node ≤ 1.5 cm by CT scan or MRI allowed
• PSA ≤ 150 ng/mL
  • Cannot have been obtained during any of the following time points:
    • 10-day period after prostate biopsy
    • After initiation of hormonal therapy
    • Within 30 days after discontinuation of finasteride
    • Within 90 days after discontinuation of dutasteride
• No distant metastases by physical exam and bone scan
  • Equivocal bone scan findings allowed if plain films are negative

Prior/Concurrent Therapy:

• At least 60 days since prior 5-alpha reductase inhibitor (e.g., finasteride) for prostatic hypertrophy
• At least 90 days since prior testosterone
• Prior pharmacologic androgen ablation for prostate cancer allowed provided androgen ablation was initiated no more than 50 days prior to study entry
• No prior radical prostatectomy, cryosurgery for prostate cancer, or bilateral orchiectomy
• No prior systemic chemotherapy for prostate cancer
  • Prior chemotherapy for a different cancer is allowed
• No prior radiotherapy, including brachytherapy, to the region of prostate cancer that would result in overlap of radiotherapy fields
• Intensity modulated radiotherapy allowed

Patient Characteristics:

• Zubrod performance status 0-1
• Platelet count ≥ 100,000/mm³
• Absolute neutrophil count ≥ 1,800/mm³
• Hemoglobin ≥ 8 g/dL (transfusion or other intervention allowed)
• ALT and AST ≤ 1.5 times upper limit of normal (ULN)
• Alkaline phosphatase ≤ 2.5 times ULN
• Bilirubin ≤ 1.5 times ULN
• Fertile patients must use effective contraception during and for at least 3 months after completion of study treatment
• No prior invasive malignancy, except nonmelanomatous skin cancer or other malignancy, unless disease-free for ≥ 3 years (e.g., carcinoma in situ of the oral cavity or bladder are allowed)
• No unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months
• No transmural myocardial infarction within the past 6 months
• No acute bacterial or fungal infection requiring intravenous antibiotics
• No AIDS
• No prior allergic reaction to any study drugs or other drugs formulated with polysorbate 80
• No existing peripheral neuropathy ≥ grade 2

Expected Enrollment

A total of 600 patients will be accrued for this study.

Outcomes

Survival at 4 years after registration

Biochemical control by prostate-specific antigen (PSA) ≥ 2 ng/mL above nadir at 4 years after registration

Outline

This is an open-label, randomized, multicenter study. Patients are stratified according to risk group.

• Arm I: Patients receive androgen suppression therapy comprising luteinizing hormone-releasing hormone (LHRH) agonist (e.g., leuprolide acetate, goserelin, buserelin, or triptorelin) and oral antiandrogen (i.e., oral flutamide 3 times daily for 2 months or oral bicalutamide once daily for 2 months). Beginning at week 8, patients undergo radiotherapy 5 days a week for approximately 8 weeks. Antiandrogen therapy is discontinued at completion of radiotherapy, but LHRH agonist therapy continues for 20 months.
• Arm II: Patients receive androgen suppression therapy and undergo radiotherapy as in arm I. Beginning 4 weeks after completion of radiotherapy, patients receive docetaxel IV over 1 hour on day 1 and oral prednisone daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients continue LHRH agonist therapy as in arm I.

After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Patel AR, Sandler HM, Pienta KJ: Radiation Therapy Oncology Group 0521: a phase III randomized trial of androgen suppression and radiation therapy versus androgen suppression and radiation therapy followed by chemotherapy with docetaxel/prednisone for localized, high-risk prostate cancer. Clin Genitourin Cancer 4 (3): 212-4, 2005.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Radiation Therapy Oncology Group

Howard Sandler, MD, Protocol chair		Ph: 734-936-9338; 800-865-1125 Email: hsandler@umich.edu
Seth Rosenthal, MD, Protocol co-chair		Ph: 916-454-6699
Kenneth Pienta, MD, FACP, Protocol co-chair		Ph: 734-936-1831; 800-865-1125
Leonard Gomella, MD, Protocol co-chair		Ph: 215-955-6963; 800-533-3669

Related Information

Featured trial article

Registry Information
Official Title		A Phase III Protocol of Androgen Suppression (AS) and 3DCTR/IMRT Vs AS and 3DCTR/IMRT Followed by Chemotherapy With Docetaxel and Prednisone for Localized, High-Risk, Prostate Cancer
Trial Start Date		2005-12-08
Trial Completion Date		2011-08-15 (estimated)
Registered in ClinicalTrials.gov		NCT00288080
Date Submitted to PDQ		2005-12-02
Information Last Verified		2009-08-19
NCI Grant/Contract Number		CA21661

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