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Phase II Trial of Androgen Suppression for 6 Months Combined With External Beam Radiotherapy (EBRT) With Brachytherapy (BT) Boost for Intermediate Risk Prostate Cancer

Phase 2
18 Years
Open (Enrolling)
Prostate Cancer

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Trial Information

Phase II Trial of Androgen Suppression for 6 Months Combined With External Beam Radiotherapy (EBRT) With Brachytherapy (BT) Boost for Intermediate Risk Prostate Cancer


- Determine the feasibility of androgen-suppression therapy combined with external-beam
radiotherapy and boost brachytherapy (EBRT+BT) in patients with intermediate-risk
localized prostate cancer.

- Determine the safety of EBRT+BT in these patients.

- Determine, in a preliminary manner, the efficacy of EBRT+BT in terms of rate of local
recurrence at 5 years, time to prostate-specific antigen failure, and time to first
rectal/bladder injury, in these patients.

OUTLINE: Patients receive either leuprolide intramuscularly or goserelin subcutaneously once
every 12 weeks for a total of 24 weeks. Patients also receive either oral flutamide three
times daily or oral bicalutamide once daily for 4 weeks.

Within 4 weeks after initiation of androgen-suppression therapy, patients undergo
external-beam radiotherapy (EBRT) once daily, 5 days a week, for 5 weeks. At 2-4 weeks after
completion of EBRT, patients undergo transrectal ultrasound-guided boost brachytherapy with
implanted iodine I 125 or palladium Pd 103 seeds.

Patients are followed every 3 months for 2 years and then every 6 months for 4 years.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

Inclusion Criteria


- Histologically confirmed adenocarcinoma of the prostate

- Must have one of the following prognostic factors:

- Stage T1-2, N0; prostate-specific antigen (PSA) ≤ 10 ng/mL; and Gleason
score > 6

- Stage T1-2, N0; PSA > 10 ng/mL and < 20 ng/mL; and Gleason score ≤ 6

- Stage T3a, N0; PSA ≤ 10 ng/mL; and Gleason score ≤ 6

- Prostate volume < 60 cc by transrectal ultrasound

- No distant or nodal metastases

- No metastatic disease by bone scan, CT scan, or MRI



- 18 and over

Performance status:

- ECOG 0-2

Life expectancy:

- Not specified


- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3


- Bilirubin ≤ 1.5 times upper limit of normal


- Not specified


- Fertile patients must use effective contraception


Biologic therapy:

- No prior immunotherapy for prostate cancer


- No prior chemotherapy for prostate cancer

Endocrine therapy:

- Prior androgen-suppression therapy for up to 4 weeks duration allowed if initiated
within 4 weeks of study radiotherapy

- No other prior hormonal therapy


- No prior radiotherapy for prostate cancer


- No prior surgery for prostate cancer

- No prior transurethral resection of the prostate


- No prior alternative therapy (e.g., PC-SPES) for prostate cancer

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Outcome Time Frame:

q 3 mon for 2 yrs post tx initiation

Safety Issue:


Principal Investigator

Mark Hurwitz, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Dana-Farber/Brigham and Women's Cancer Center


United States: Federal Government

Study ID:




Start Date:

September 2000

Completion Date:

March 2012

Related Keywords:

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



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