Radiation Therapy With or Without Antiandrogen Therapy in Treating Patients With Stage I or Stage II Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: flutamide; Zoladex; Lupron; radiation therapy
Intervention description: Two 125 mg capsules (t.i.d., p.o.) beginning two months before RT and continuing until RT is completed.; 3.6 mg s.c. monthly x 4 beginning two months before RT and continuing until RT is completed. The 3-month preparation may be used instead of three separate monthly injections.; 7.5 mg IM (intramuscular) monthly x 4 beginning two months before RT and continuing until RT is completed. The 3-month preparation may be used instead of three separate monthly injections.; 46.8 Gy (1.8 Gy/day four to five times a week [26 fx]) to regional lymphatics followed by 19.8 Gy (1.8 Gy/day x 11 fx) for a total of 66.6 Gy to the prostate. Prostate only may be treated in defined circumstances.
Intervention MeSH terms: Leuprolide; Goserelin; Flutamide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 2028.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: adenocarcinoma of the prostate; stage I prostate cancer; stage IIB prostate cancer; stage IIA prostate cancer

Summary:

      RATIONALE: Radiation therapy (RT) uses high-energy x-rays to damage tumor cells. Androgens
      can stimulate the growth of prostate cancer cells. Hormone therapy using flutamide,
      goserelin, and leuprolide may fight prostate cancer by reducing the production of androgens.
      It is not yet known which regimen of antiandrogen therapy is most effective for prostate
      cancer.

      PURPOSE: Randomized phase III trial to study the effectiveness of radiation therapy with or
      without antiandrogen therapy in treating patients who have stage I or stage II prostate
      cancer.
    

Eligibility criteria:

        Inclusion criteria:

          -  Histologically confirmed locally confined adenocarcinoma of the prostate with primary
             tumors confined to the prostate, clinical stage T1b,1c, 2a or 2b.

          -  Negative nodes evaluated by imaging methods (classified in the study as NX) or by
             surgical sampling (classified in the study as N0).

          -  Karnofsky performance status ≥ 70.

          -  PSA is mandatory, must be ≤ 20)

          -  No prior hormonal therapy, radiation or chemotherapy.

          -  Prior finasteride for prostate hypertrophy allowed if discontinued at least 60 days
             prior to randomization.

          -  Prior testosterone administration allowed if at least 90 days elapsed since last
             administration.

          -  No evidence of distant metastasis or other synchronous primary. Patients with prior
             invasive malignancy who were disease free for at least 5 years could be eligible with
             pre-randomization approval by the study chairman.

          -  Treatment begins within 21 days after randomization.

          -  Patients signs a study-specific informed consent form.

          -  Alanine Aminotransferase (ALT) within 2x upper normal limits.

        Exclusion criteria:

          -  Stage T1a or ≥ T2c disease.

          -  Lymph node involvement (N1 - N3).

          -  Evidence of distant metastasis. (M1)

          -  PSA > 20.

          -  Radical surgery or cryosurgery for carcinoma of the prostate, previous irradiation,
             antiandrogen therapy or chemotherapy.

          -  Previous or concurrent cancers other than basal cell or squamous cell skin carcinoma.

        Patients with squamous cell carcinomas required to be NED (no evidence of disease) for a
        minimum of two years prior to study entry.

          -  Major medical or psychiatric illness which, in the investigator's opinion, would
             prevent completion of treatment and would interfere with follow-up.

          -  Karnofsky performance status of < 70.