Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase III Randomized Study Of High Dose 3D-CRT/IMRT Versus Standard Dose 3D-CRT/IMRT In Patients Treated For Localized Prostate Cancer
Brief Summary: RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. It is not yet known which dose of radiation therapy is more effective in treating stage II prostate cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of two different doses of specialized radiation therapy in treating patients who have stage II prostate cancer.


Options:
A: 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
B: 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
C: Inclusion Criteria:

1. Biopsy proof of adenocarcinoma of the prostate.
2. Bone scan (If PSA \>10 ng/ml or T3 disease) within 3 months of starting androgen ablation or signing protocol consent if no androgen ablation.
3. CT-scan of pelvis (If Stage T3 disease) within 3 months of starting androgen ablation or signing protocol consent if no androgen ablation.
4. Suitable medical condition; Zubrod \<2.
5. Pretreatment PSA \</=20 ng/ml. If PSA \<4, must have Gleason greater than or equal to 7 and/or Stage T2b-T2c. PSA within 30 days of signing protocol consent. If neoadjuvant androgen ablation has been given, then the preandrogen ablation PSA should be used for stratification.
6. Clinical (palpable) Stage T1b - T3b disease (1992 AJCC staging system).
7. While a transrectal ultrasound will be obtained before treatment, the staging will not be based on these findings. If palpable T3 disease is present, then must have Gleason score \<8 and pretreatment PSA less than or equal to 10 ng/ml
8. Gleason score \<10.
9. If Gleason score 8 or 9, then must have stage T1/T2 disease and pretreatment PSA less than or equal to 10 ng/ml.
10. The patient must be able to understand the protocol and adhere to follow-up at 6-month intervals for the first 2 years and at yearly intervals thereafter.
11. Informed consent must be given.
12. Patients randomized to Arm 1 may also participate in protocol 2004-0428.

Exclusion Criteria:

1. Prior pelvic radiotherapy.
2. Greater than 4 months of prior hormone ablation therapy.
3. Prior or planned radical prostate surgery.
4. Clinical, radiographic or pathologic evidence of nodal or distant metastatic disease.
5. Concurrent, active malignancy, other than nonmetastatic skin cancer or early stage -chronic lymphocytic leukemia (well-differentiated small cell lymphocytic lymphoma). If a prior malignancy is in remission for greater than or equal to 5 yr then the patient is eligible.
6. Zubrod status greater than or equal to 2.
7. Pretreatment PSA \>20 ng/ml.
8. Gleason score of 10.
9. Palpable stage T3c (seminal vesicle involvement) or T4 disease.
D: DISEASE CHARACTERISTICS:

* Histologically confirmed adenocarcinoma of the prostate

  * Clinical stage T1b-T2b
* Meets one of the following criteria:

  * Gleason score 2-6 AND prostate-specific antigen (PSA) ≥ 10 ng/mL but \< 20 ng/mL
  * Gleason score 7 AND PSA \< 15 ng/mL
* No regional lymph node involvement
* No distant metastases

PATIENT CHARACTERISTICS:

Age:

* Any age

Performance status:

* Zubrod 0-1

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Not specified

Other:

* No other invasive malignancy within the past 5 years except localized basal cell or squamous cell skin cancer
* No other major medical or psychiatric illness that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* No prior cytotoxic chemotherapy
* No concurrent cytotoxic chemotherapy

Endocrine therapy:

* At least 3 months since prior finasteride
* No other prior hormonal therapy, including:

  * Luteinizing hormone-releasing hormone agonists (e.g., goserelin or leuprolide)
  * Antiandrogens (e.g., flutamide or bicalutamide)
  * Estrogens (e.g., diethylstilbestrol)
* No concurrent (neoadjuvant or adjuvant) hormonal therapy

Radiotherapy:

* No prior pelvic irradiation or brachytherapy

Surgery:

* No prior radical surgery (prostatectomy) or cryosurgery for prostate cancer
* No prior surgical castration (bilateral orchiectomy)

Other:

* At least 3 months since prior finasteride or phytoestrogen preparation (PC-SPES)

Answer: D