Please select the eligibility criteria that correspond to the clinical trial below.
Title: Phase III Randomized Comparison of Pelvic Radiotherapy Alone vs Pelvic Radiotherapy Plus the LHRH Analogue Goserelin and Cyproterone Acetate in Carcinoma of the Prostate at High Risk for Metastasis
Brief Summary: RATIONALE: Radiation therapy uses high energy x rays to kill tumor cells. This may be an effective treatment for prostate cancer. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as goserelin and cyproterone, may lessen the amount of androgens made by the body and reduces the amount of androgens available to the body. It is not yet know whether radiation therapy alone is more effective than radiation therapy given together with goserelin and cyproterone in treating patients with prostate cancer.

PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared to giving radiation therapy together with goserelin and cyproterone in treating patients with prostate cancer that is at high risk for metastasis.


Options:
A: DISEASE CHARACTERISTICS:

* Histologically confirmed adenocarcinoma of the prostate
* Prostate-specific antigen (PSA) relapse OR incurable disease diagnosed within the past 2 months AND meets criteria for either of the following groups:

  * Group 1

    * In PSA relapse after definitive radical treatment (prostatectomy or radiotherapy), as evidenced by 1 the following:

      * Post-prostatectomy PSA level ≥ 0.2 ng/mL
      * At least 3 rising PSA levels (post-radiotherapy) obtained ≥ 1 month apart, with the last PSA obtained within the past 2 months
    * No metastatic disease by bone scan or abdomino-pelvic CT scan
  * Group 2

    * Not suitable for radical treatment at primary diagnosis
    * Not planning to receive curative treatment
    * Localized or metastatic disease

      * No symptomatic disease requiring radiotherapy or immediate hormonal therapy
* No symptomatic disease requiring therapy

PATIENT CHARACTERISTICS:

Age

* Any age

Performance status

* Not specified

Life expectancy

* At least 5 years

Hematopoietic

* Not specified

Hepatic

* Not specified

Renal

* Not specified

Other

* No other significant comorbid condition that would limit life expectancy to \< 5 years

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* Not specified

Endocrine therapy

* At least 12 months since prior androgen deprivation therapy (ADT) administered in the neoadjuvant or concurrent (with radiotherapy) setting (group 1)
* No prior ADT (group 2)

Radiotherapy

* See Disease Characteristics
* See Endocrine therapy

Surgery

* See Disease Characteristics

Other

* No concurrent enrollment in TROG-96.01 or TROG-RADAR protocols
B: DISEASE CHARACTERISTICS: Histologically proven prostatic adenocarcinoma of the following TNM stages and WHO grades: T1 or T2 and grade G3 T3 or T4 and any histologic grade No evidence of distant metastases No evidence of positive common iliac or para-aortic lymph nodes Confirmed by bone scan, chest x-ray, negative ultrasound or CT of the liver, and CT of the retroperitoneum and/or bipedal lymphangiography Extraperitoneal pelvic lymph node biopsy may be either positive or negative provided stage and grade criteria are met

PATIENT CHARACTERISTICS: Age: Under 80 Performance status: WHO 0-2 Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No history of second malignancy except basal cell skin carcinoma

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for prostate cancer Endocrine therapy: No prior hormonal therapy for prostate cancer Radiotherapy: No prior radiotherapy for prostate cancer Surgery: No prior radical prostatectomy No prior transperitoneal lymph node staging
C: Inclusion Criteria:

* Prostate cancer in the early stage of disease
* Prostate removed and/or radiation therapy to the prostate area

Exclusion Criteria:

* Previous systemic therapy for prostate cancer
* Previous history of another form of cancer (not prostate) within 5 years of study start.
D: Inclusion Criteria:

* Clinical diagnosis of non-metastatic cancer of the prostate gland
* Patient to be 18 years and above

Exclusion Criteria:

* Previous systemic therapy for prostate cancer
* Previous history of another form of cancer (not prostate) within 5 years of study start.

Answer: B