Please select the eligibility criteria that correspond to the clinical trial below.
Title: Role of Soy Isoflavones in Prostate Cancer Prevention
Brief Summary: This is a randomized study evaluating the effectiveness and direct effect a commercial soy supplement has on prostate cancer and normal prostate tissue. Patient will be randomized it either receive placebo or a commercial soy supplement for 2-4 weeks prior to the planned surgery for treatment of their prostate cancer. Patient's blood and prostate tissue will be evaluated to determine the effects of the soy supplement on the prostate tissue.


Options:
A: DISEASE CHARACTERISTICS:

* Diagnosis of cancer that supports the use of radiotherapy to the pelvis
* No current or prior metastases beyond pelvic regional lymph nodes
* Planning to receive a course of continuous definitive or adjuvant external-beam radiotherapy to a minimum dose of 4500 cGy with or without fluorouracil, capecitabine, or oxaliplatin
* Planned course of pelvic radiotherapy must fall within the following parameters:

  * Pelvis must be encompassed by the planned radiotherapy fields

    * Superior border may not lie superior to the L4-5 interspace and may not be inferior to the most inferior aspect of the sacroiliac joints
    * Portions of the rectum may have special blocking, depending upon disease site
  * Total planned dose to the central axis midplane (for AP-PA parallel opposed fields) or isocenter (for 3- or 4-field techniques) for the pelvic field must lie between 4500-5300 cGy (inclusive)\*

    * Subsequent to completion of treatment to the pelvic field, a boost to primary tumor or tumor bed may be planned
  * Planned treatment is to be given 4-5 times per week on a one-treatment-per-day basis

    * Daily dose (specified at central axis midplane or at isocenter for multi-field techniques) must lie between 170-210 cGy (inclusive) per day\*
* NOTE: \*For institutions that do not use midplane or isocenter as the point for specification of dose, it will be necessary to determine the dose according to the methods specified above in order to determine patient eligibility.
* No perineal irradiation planned (e.g., anal cancer patients, patients who have had an abdominal-perineal resection)
* No brachytherapy planned before the completion of all external-beam radiotherapy
* No planned split-course radiotherapy

PATIENT CHARACTERISTICS:

* ECOG performance status 0-2
* Life expectancy ≥ 6 months
* Hemoglobin ≥ 10.0 g/dL
* Leukocytes ≥ 3,500/mm\^3
* ANC ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Creatinine ≤ 1.5 times upper limit of normal (ULN)
* AST ≤ 1.5 times ULN
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Willing to provide blood specimens as required by the study (Mayo Clinic Rochester patients only)
* Able to complete questionnaires alone or with assistance
* No history of inflammatory bowel disease
* No history of gastrointestinal or genitourinary obstruction or porphyria
* No history of G6PD deficiency
* No history of irritable bowel syndrome
* No history of blood dyscrasia
* No history of severe allergies or asthma
* No history of hepatic or renal disease
* No diarrhea ≥ grade 3, rectal bleeding, abdominal cramping, or incontinence of stool within the past week
* No medical condition that may interfere with the ability to receive study treatment
* No known allergy to sulfasalazine, sulfa medications, salicylates, or any known component of drug formulation

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No prior pelvic radiotherapy
* No prior abdominal-perineal resection, Hartmann procedure, or other surgical procedure leaving the patient without a functioning rectum
* No planned use of leucovorin or cytotoxic chemotherapeutic agents concurrent with radiotherapy (except for fluorouracil, capecitabine, or oxaliplatin)
* No other concurrent sulfasalazine
* No concurrent digoxin
B: Inclusion Criteria:

* Advanced cervical cancer

Exclusion Criteria:

* Previously treated for cancer of the cervix
* Karnofsky Performance Score less than 50
* Renal dysfunction ( Serum creatinine \> 2.0mg/dl)
* Hepatic dysfunction (Serum bilirubin\> 2.0 mg/dl, transaminases \> 1.5 times normal)
* Pregnant or lactating women: Women will be tested by pregnancy test for possibility of existing pregnancy. Those that meet criteria of trial will be asked to promise that they don't become pregnant; barrier contraception will be recommended.
C: DISEASE CHARACTERISTICS:

* Histologically confirmed adenocarcinoma of the prostate

  * Clinical stage T1b-T3c disease
  * No clinical or radiographic evidence of metastasis
* Prostate-specific antigen (PSA) less than 80 ng/mL
* Gleason score at least 5
* One of the following criteria must be met:

  * PSA greater than 10 ng/mL
  * Gleason score greater than 6
  * T2b or greater palpable disease
  * Three or more biopsy cores involved with a Gleason score of at least 5

PATIENT CHARACTERISTICS:

Age

* Not specified

Performance status

* Zubrod 0-1

Life expectancy

* Not specified

Hematopoietic

* Not specified

Hepatic

* Not specified

Renal

* Not specified

Other

* No other medical condition that would preclude study participation
* No other active malignancy within the past 5 years except nonmetastatic skin cancer or early stage chronic lymphocytic leukemia (well-differentiated small cell lymphocytic leukemia)
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* Not specified

Endocrine therapy

* No more than 4 months of prior androgen deprivation therapy
* Neoadjuvant and adjuvant androgen deprivation therapy is allowed for high-risk disease only

Radiotherapy

* No prior pelvic radiotherapy

Surgery

* No prior or planned radical prostate surgery
D: Inclusion Criteria:

* Histologically proven prostate cancer.
* Surgical candidate for prostatectomy.
* During study period, must agree not to take new supplements.
* No concurrent chemotherapy, radiation or hormonal therapy.
* No history of prior allergy to soy based products.
* Must not have been taking soy supplements or soy isoflavones within 90 days prior to study enrollment.
* Must be able to safely be on study supplements for period of at least two weeks prior to scheduled prostatectomy.
* Must give written and informed consent in accordance with institutional and federal guidelines.

Exclusion Criteria:

During study period, must agree not to take new supplements.

* No concurrent chemotherapy, radiation or hormonal therapy.
* No history of prior allergy to soy based products.
* Must not have been taking soy supplements or soy isoflavones within 90 days prior to study enrollment.
* Must be able to safely be on study supplements for period of at least two weeks prior to scheduled

Answer: D