Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Parallel-Group Trial Comparing Bicalutamide (Casodex) 150mg Once Daily With Placebo in Patients With Non-metastatic Prostate Cancer
Brief Summary: The purpose of this trial is to study the effect of adjuvant or immediate hormonal therapy, versus placebo, in subjects who have either undergone a primary therapy (principally radical prostatectomy or radiotherapy) or who were otherwise to be managed by watchful waiting.


Options:
A: 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.
B: Inclusion Criteria:

* Biopsy proven prostate cancer
* Negative bone scan
* Lymph nodes by CT or MRI
* Adequate blood work
* Performance Status - ECOG 0-1
* Life expectancy of at least 10 years
* \>40 years of age

Exclusion Criteria:

* Prior history of malignancy
* Prior hormonal therapy or chemotherapy
* Prior pelvic radiation therapy
* Unable to tolerate lying still 5-10 minutes/day
C: 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
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: A