Please select the eligibility criteria that correspond to the clinical trial below.
Title: Phase III Study for Prostate Cancer, Randomizing Between Two Radiation Dose Levels (68 Gy vs. 78 Gy) and Utilizing Three Dimensional Conformal Radiotherapy
Brief Summary: 3-D conformal radiotherapy offers the opportunity to reach higher tumor doses with acceptable complication rates compared to conventional radiotherapy. There are retrospective and preliminary prospective reports of a better local control / disease free survival (including PSA control) using higher tumor doses. A prospective randomised phase III study is required to validate these reports. The purpose of this randomized phase III study is to investigate and compare the tumor control and toxicity in prostate cancer patients treated to 68 Gy and 78 Gy;


Options:
A: 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.
B: 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.
C: DISEASE CHARACTERISTICS:

* Histologically confirmed adenocarcinoma of the prostate

  * Unfavorable disease, defined by at least 1 of the following criteria:

    * Clinical stage T3 or T4
    * Gleason score ≥8
    * Serum prostate-specific antigen (PSA) ≥20 ng/mL and ≤100 ng/mL
* pN0 disease allowed if lymphadenectomy performed before patient began hormone therapy
* No pelvic lymph nodes ≥15 mm by CT scan or MRI
* No axillary lymph node involvement (pN1)
* No bone metastasis
* Must be starting hormonal treatment on or up to 6 months before beginning radiotherapy

PATIENT CHARACTERISTICS:

* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Life expectancy \>5 years
* Must be enrolled in a social security program
* No other cancer, except basal cell skin cancer, that has been treated or relapsed within the past 5 years
* No severe uncontrolled hypertension (systolic BP ≥160 mm Hg or diastolic BP ≥90 mm Hg)
* No contraindication to luteinizing hormone-releasing hormone agonists
* No contraindication to pelvic irradiation (e.g., scleroderma, chronic inflammatory gastrointestinal disease)
* No hip prosthesis
* Must not be deprived of liberty or under guardianship
* No geographical, social, or psychological reasons that would preclude follow up

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No prior pelvic irradiation
* At least 3-4 months since prior transurethral resection
* No other prior surgery for prostate cancer
* No concurrent participation in another clinical trial which would require approval upon entry to this trial
D: 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

Answer: D