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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

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Trial Conditions
  • Prostate Cancer
What is the purpose of this trial?

RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as leuprolide, goserelin, flutamide, or bicalutamide, may stop the adrenal glands from making androgens. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving these drugs together with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well androgen suppression with either leuprolide or goserelin and either flutamide or bicalutamide together with radiation therapy works in treating patients with prostate cancer.

Date & Status

Completed

Who can Participate?

Eligibility

Ages:
18 and older

Gender:
Male

Eligibility

DISEASE CHARACTERISTICS:

- 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

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- ECOG 0-2

Life expectancy:

- Not specified

Hematopoietic:

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

- Platelet count ≥ 100,000/mm^3

Hepatic:

- Bilirubin ≤ 1.5 times upper limit of normal

Renal:

- Not specified

Other:

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No prior immunotherapy for prostate cancer

Chemotherapy:

- 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

Radiotherapy:

- No prior radiotherapy for prostate cancer

Surgery:

- No prior surgery for prostate cancer

- No prior transurethral resection of the prostate

Other:

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

Gender: Male
Steward Physician(s)
  • Mark Hurwitz, MD
Facilities
  • Saint Anne's Hospital - Completed
Trial Interventions
Drug
  • LHRH agonist
  • antiandrogen
Radiation
  • radiation therapy
  • Brachytherapy boost
Physician Researcher

Investigator Name:

  • Mark Hurwitz, MD

Other Information

Sponsor: Cancer and Leukemia Group B
Phase: Phase 2
Trial ID: NCT00006359
Volunteers:  Not Accepting Healthy Volunteers

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