Please select the eligibility criteria that correspond to the clinical trial below.
Title: Conformational, Curative Ratiotherapy For Prostate Cancer (NO, N-): Phase III Multicenter Study Of The Contribution To Survival Without Clinical Or Biological Change With A Dose Variation Of 15% (80 Gy VS 70 Gy)
Brief Summary: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which regimen of radiation therapy is more effective for prostate cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of different regimens of radiation therapy in treating patients who have localized prostate cancer.


Options:
A: 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
B: DISEASE CHARACTERISTICS: Localized prostate cancer: T2a-T3a OR T1b or T1c with PSA at least 10 ng/mL OR T1b or T1c with Gleason score 7-10 No T3b or T4; positive biopsy of nodal excision N0, or any N with bilateral removal and the estimated risk of nodal invasion is at least 10% M0 (by bone scintograph and chest x-ray) PSA less than 50 ng/mL

PATIENT CHARACTERISTICS: Age: Under 75 Performance status: WHO 0-1 Life expectancy: At least 10 years Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No other prior invasive malignancy within the past 5 years except basal cell carcinoma No social, familial, or geographic obstacles that would preclude study

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy No concurrent biologic therapy Chemotherapy: No prior chemotherapy No concurrent chemotherapy Endocrine therapy: No prior hormonal therapy including adjuvant therapy No concurrent hormonal therapy Radiotherapy: No prior pelvic radiotherapy Surgery: No prior radical anterior prostatectomy for cancer No prior castration
C: 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.
D: 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

Answer: B