Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase III Randomized Study of Hypofractionated 3D-CRT/MRT Versus Conventionally Fractionated 3D-CRT/MRT in Patients With Favorable-Risk Prostate Cancer
Brief Summary: RATIONALE: Giving radiation therapy that uses a 3-dimensional (3-D) image of the tumor to help focus thin beams of radiation directly on the tumor, and giving hypofractionated radiation therapy (higher doses over a shorter period of time), may be less costly with fewer side effects and just as effective in treating prostate cancer.

PURPOSE: This randomized phase III trial is studying several different radiation therapy regimens to compare how well they work in treating patients with stage II prostate cancer.


Options:
A: Inclusion Criteria:

Fit for the treatments and estimates life expectancy of 10 years Registration with eligible primary care practice

Exclusion Criteria:

Unable to give written informed consent. Concomitant or past malignancy.
B: Inclusion Criteria:

* locally confined adenocarcinoma of the prostate
* all T-stages with a PSA \< 60ng/ml, except any T1a tumor and well-differentiated (or Gleason score \< 5) T1b-c tumors with PSA-levels ≤ 4 ng/ml
* Karnofsky Performance Status of 80 or more

Exclusion Criteria:

* distant metastases
* positive regional lymph nodes proven by surgical or cytological sampling
* on anticoagulants
* previous prostatectomy
* previous pelvic irradiation
C: Inclusion Criteria:

* Patients with stage T1 or T2 untreated adenocarcinoma of the prostate, with a Gleason score that is less than or equal to 6, as well as a prostate-specific antigen (PSA) between 10-20 (intermediate risk) or patients with stage T1 or T2 untreated adenocarcinoma of the prostate, with a Gleason score that is equal to 7, as well as a PSA equal to or less than 20 (intermediate risk).
* Performance status score of 0-1
* Patients must sign a consent form before starting the study.
* No evidence of regional disease
* Patients with a previous history of cancer are eligible on the condition that they have been disease-free for more than five years.
* Non-invasive epidermoid cancers of the skin are eligible.
* The patient must be available for treatments and follow-up visits.
* No evidence of metastatic disease, confirmed by a negative bone scan.

Exclusion Criteria:

* Severe medical or psychiatric problems that may compromise study compliance
* Chronic hepatic disease; abnormal hepatic function, i.e. aspartate aminotransferase and alanine aminotransferase \> 1.5 times the upper normal limit.
D: DISEASE CHARACTERISTICS:

* Histologically confirmed adenocarcinoma of the prostate within the past 6 months

  * Clinical stage T1-2c
* Combined Gleason score 2-6
* Prostate-specific antigen (PSA) \< 10 ng/mL within the past 6 months

  * PSA evaluated at least 10 days after prostate biopsy
  * For patients who received finasteride, PSA evaluated at least 30 after completion of finasteride
  * For patients who received dutasteride, PSA evaluated at least 90 after completion of dutasteride
* No regional lymph node involvement
* No distant metastases

PATIENT CHARACTERISTICS:

* Zubrod performance status 0-1
* No unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months
* No transmural myocardial infarction within the past 6 months
* No acute bacterial or fungal infection requiring IV antibiotics
* No chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study treatment
* No hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
* No known AIDS
* No prior or concurrent lymphomatous/hematogenous malignancy or other invasive malignancy except nonmelanomatous skin cancer or any other cancer for which the patient has been continually disease-free for ≥ 5 years (e.g., carcinoma in situ of the bladder or oral cavity)
* No other severe, active comorbidity

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No prior radical prostatectomy or cryosurgery for prostate cancer
* No prior hormonal therapy, including any of the following:

  * Luteinizing hormone-releasing hormone agonists (e.g., goserelin or leuprolide)
  * Antiandrogens (e.g., flutamide or bicalutamide)
  * Estrogens \[e.g., diethylstilbestrol (DES)\]
  * Surgical castration (bilateral orchiectomy)
* No prior pelvic radiotherapy or prostate brachytherapy
* No prior or concurrent cytotoxic chemotherapy for prostate cancer
* At least 30 days since prior finasteride
* At least 90 days since prior dutasteride
* No concurrent neoadjuvant or adjuvant hormonal therapy
* Concurrent warfarin or other blood-thinning agents allowed

Answer: D