Overview

Hormone Therapy and Radiation Therapy in Treating Patients With Prostate Cancer

Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
Male
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Radiation Therapy Oncology Group
Collaborator:
National Cancer Institute (NCI)
Treatments:
Bicalutamide
Flutamide
Hormones
Prolactin Release-Inhibiting Factors
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.