Hormone Therapy and Radiation Therapy in Treating Patients With Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Casodex; Eulexin; LHRH agonist; radiation therapy
Intervention description: Orally at a dose of one 50 mg tablet per day started within (before or after) 14 days of the first LHRH agonist injection.; Orally at a dose of two 125 mg capsules three times a day for a total daily dose of 750 mg (six capsules) started within (before or after) 14 days of the first LHRH agonist injection.; LHRH agonist of choice. The manufacturer's instructions should be followed.; [Prostate and any extraprostatic tumor extension + 1.0-1.5 cm margin receives 70.2 Gy (1.8 Gy/day x 39 fractions, five days/week)] OR [regional nodes, prostate and seminal vesicles + 1.0-1.5 cm margin will receive 46.8 Gy (1.8 Gy/day x 26 fractions, five days/week), followed by a 23.4 Gy (1.8 Gy/day x 13 fractions, five days/week) boost to the prostate and any extraprostatic tumor extension + 1.0-1.5 cm margin]
Intervention MeSH terms: Bicalutamide; Flutamide; Hormones; Prolactin Release-Inhibiting Factors
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1579.0
Sex: Male
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: adenocarcinoma of the prostate; stage IIB prostate cancer; stage IIA prostate cancer; stage III prostate cancer

Summary:

      RATIONALE: Hormones can stimulate the growth of prostate cancer cells. Hormone therapy may
      fight prostate cancer by reducing the production of androgens. Radiation therapy uses
      high-energy x-rays to damage tumor cells. It is not yet known which regimen of hormone
      therapy and radiation therapy is more effective for prostate cancer.

      PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of
      hormone therapy and radiation therapy in treating patients who have prostate cancer.
    

Eligibility criteria:

        Inclusion Criteria

          1. Adenocarcinoma of prostatic origin histologically-confirmed within 180 days of the
             randomization date.

          2. Zubrod Performance Status 0-1 (Appendix II).

          3. Prostatic biopsy tumor grading by the Gleason Score classification (Appendix VI) is
             mandatory prior to randomization.

          4. Patients at intermediate risk for disease relapse as determined by any of the
             following combinations of factors (NOTE: tumor found in one or both lobes on biopsy,
             but not palpable, will not alter T stage):

               -  Clinical stage T1b-4, Gleason score 2-6, and prostate-specific antigen >10 but ≤
                  100.

               -  Clinical stage T1b-4, Gleason score 7, and prostate-specific antigen < 20.

               -  Clinical stage T1b-1c, Gleason score 8-10, and prostate-specific antigen <20.

          5. Clinically negative (N0) lymph nodes (LN) as established by imaging (pelvic ±
             abdominal CT, MRI or LAG), or negative LN by nodal sampling or dissection (laparoscopy
             or laparotomy). Patients with radiologic (e.g., CT, MRI or LAG) or
             radioimmunoscintigraphy (i.e., ProstaScint™) findings suggestive of regional nodal
             involvement are eligible if cytologic (e.g., needle aspiration) or histologic (e.g.,
             surgical sampling) evaluation shows no evidence of a neoplastic process (i.e.,
             prostatic or non-prostatic malignancy). Patients with equivocal radiologic findings
             (maximum nodal size ≤ 1.5 cm) are eligible.

          6. No distant (M0) metastases. Patients with radionuclide imaging (e.g., bone
             scintigraphy, ProstaScint™) findings suggestive, but not diagnostic of metastatic
             disease are eligible if radiologic (e.g., standard or tomographic radiography, or
             CT/MRI) imaging does not confirm metastatic disease.

          7. Pretherapy serum (total) prostate-specific antigen value performed with a Federal Drug
             Administration approved assay method, e.g. Abbott, Hybritech, etc.

          8. Treatment must begin within 6 weeks after randomization.

          9. Alanine aminotransferase (ALT) must be within 2 x upper normal limit.

         10. Patients must sign a study-specific informed consent form (Appendix I) prior to
             randomization.

        Exclusion Criteria

          1. Patients at high risk for disease relapse as determined by either:

               -  Prostate-specific antigen ≥ 20 and Gleason score ≥ 7 (any T stage).

               -  Clinical stage ≥T2 and Gleason score ≥ 8 (any prostate-specific antigen).

          2. Patients at low risk for disease relapse as determined by:

             • Clinical stage ≤T2, Gleason score ≤ 6, and prostate-specific antigen ≤ 10.

          3. Clinical stage Tx, T0, or T1a.

          4. Histologic or radiologic evidence of tumor involvement of regional lymph nodes (N1) or
             the presence of metastatic disease (M1).

          5. Pretherapy serum prostate-specific antigen level > 100.

          6. Co-morbid medical illness which in the opinion of the investigator is expected to
             result in a life expectancy of <10 years.

          7. Any of the following prior therapies:

               -  Pelvic external beam radiation therapy.

               -  Radionuclide prostate brachytherapy.

               -  Prostatectomy or prostatic cryosurgery.

               -  Prior bilateral orchiectomy.

               -  Prior androgen suppression therapy; however, patients begun on LHRH agonist
                  therapy remain eligible if (1) LHRH agonists were started no more than 30 days
                  before randomization, and (2) Casodex or Eulexin was (or will be) started no more
                  than 14 days before or after the date that the LHRH agonist injection was given.
                  Any finasteride therapy administered for prostatic hypertrophy must be
                  discontinued.

               -  Chemotherapy for prostatic carcinoma.

          8. Previous or concomitant invasive cancer, other than localized basal cell or squamous
             cell skin carcinoma (AJCC Stage 0-II), unless continually disease free for at least 5
             years.

          9. Major medical or psychiatric illness which, in the opinion of the investigator, would
             prevent completion of treatment or would interfere with follow-up.

         10. The patient's participation in another medical research study that involves prostate
             cancer treatment.