araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 81-year-old male with Prostate cancer. Genetic variant: PTEN Inactivating. Other conditions: Hypertension, Depression.

Clinical trial: Radiation Therapy Plus Amifostine in Treating Patients With Primary Prostate Cancer

Summary: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Amifostine may protect normal cells from the side effects of radiation therapy.
  PURPOSE: Phase II trial to study the effectiveness of radiation therapy plus amifostine in treating patients with primary prostate cancer.

Detailed description: OBJECTIVES: I. Determine the incidence, grade, and time course of acute grade 2 or higher gastrointestinal and genitourinary toxicities in patients with primary prostate adenocarcinoma receiving amifostine plus fractionated radiotherapy. II. Determine the incidence and nature of toxicity associated with amifostine in these patients. III. Assess tumor response to this treatment in these patients. IV. Assess impotency rates following radiotherapy in these patients.
  OUTLINE: This is an open label study. Patients receive fractionated radiotherapy five days per week for 7 weeks plus amifostine IV push over 5 minutes, 15 minutes before each radiation treatment. Patients are followed at 1 month after radiotherapy, and then every 3 months for at least 5 years.
  PROJECTED ACCRUAL: There will be 25 patients accrued into this study over 2 years.

Eligibility: DISEASE CHARACTERISTICS: Histologically confirmed prostate adenocarcinoma Stage T1a-T3b N0 M0 disease PSA at least 10 ng/mL prior to treatment Must have a risk of seminal vesicle involvement between 10-25% No palpable or radiographic evidence of seminal vesicle involvement
  PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Greater than 24 months Hematopoietic: Not specified Hepatic: SGOT and SGOT no greater than 2.5 times upper limit of normal Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No severe cerebrovascular disease or sustained hypotension not secondary to antihypotensive medication Other: No history of inflammatory bowel disease No history of malignancy other than nonmelanoma skin cancer No underlying medical or psychiatric illness that may impair ability to participate in study
  PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to the prostate area Surgery: No prior radical prostatectomy Other: No hypertensive medications if blood pressure less than 120/70

Relevance to patient case: not relevant
Patient case: 81-year-old male with Prostate cancer. Genetic variant: PTEN Inactivating. Other conditions: Hypertension, Depression.

Clinical trial: Effect of Androgen Suppression on Bone Loss in Patients With or Without Bone Metastases Secondary to Prostate Cancer

Summary: RATIONALE: Assessing the effect of androgen suppression on bone loss in prostate cancer patients may improve the ability to plan treatment, may decrease the risk of fractures and bony pain, and may help patients live more comfortably.
  PURPOSE: Clinical trial to determine the effect of androgen suppression on bone loss in patients who have prostate cancer.

Detailed description: OBJECTIVES:
  -  Evaluate the effect of androgen ablation on bone resorption in patients with or without bone metastases secondary to prostate cancer.
  OUTLINE: Patients are stratified according to prior androgen ablation therapy (yes vs no) and metastatic disease (yes vs no).
  Patients undergo blood work and 24 hour urine collection on day 1 and at week 6-8. Patients who have received androgen ablation therapy and are found to have increased bone resorption undergo a dual energy x-ray absorptiometry (DEXA) scan.
  A comparison is made between androgen ablation therapy and bone resorption and if metastases are associated with the two.
  PROJECTED ACCRUAL: A total of 150 patients will be accrued for this study within 9 months.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed prostate cancer
  -  Stratum 1 (androgen ablation therapy):
  -  Bone metastases
  -  Prior orchiectomy allowed
  -  Prior or concurrent leuprolide and/or goserelin therapy allowed
  -  Stratum 2 (androgen ablation therapy):
  -  No bone metastases
  -  Prior orchiectomy allowed
  -  Prior or concurrent leuprolide and/or goserelin therapy allowed
  -  Stratum 3 (no androgen ablation therapy):
  -  No metastatic disease
  -  Prior flutamide or bicalutamide therapy allowed
  PATIENT CHARACTERISTICS:
  Age:
  -  Not specified
  Performance status:
  -  Not specified
  Life expectancy:
  -  Not specified
  Hematopoietic:
  -  Calcium normal
  Hepatic:
  -  Not specified
  Renal:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  Not specified
  Chemotherapy:
  -  See Disease Characteristics
  Endocrine therapy:
  -  See Disease Characteristics
  -  No concurrent high dose steroids
  Radiotherapy:
  -  Prior radiotherapy allowed
  Surgery:
  -  See Disease Characteristics
  -  Prior radical prostatectomy allowed
  Other:
  -  No concurrent bisphosphonates

Relevance to patient case: not relevant
Patient case: 81-year-old male with Prostate cancer. Genetic variant: PTEN Inactivating. Other conditions: Hypertension, Depression.

Clinical trial: EF5 Prior to Surgery or Biopsy in Patients With Breast, Prostate, or Cervical Cancer or High Grade Soft Tissue Sarcoma

Summary: RATIONALE: EF5 may detect the presence of oxygen in tumor cells and help plan effective cancer treatment.
  PURPOSE: Phase I trial to study the effectiveness of EF5 in detecting the presence of oxygen in tumor cells of patients who are undergoing surgery or biopsy for breast, prostate, or cervical cancer or high grade soft tissue sarcoma.

Detailed description: OBJECTIVES: I. Determine the optimal dose of etanidazole derivative EF5 that is safely tolerated and provides optimal binding in resected tumor specimens or tumor biopsies in patients with breast, head and neck, prostate, or cervical carcinoma or high grade soft tissue sarcomas. II. Define the toxic effects of EF5 in this patient population.
  OUTLINE: This is a dose-escalation study. Patients receive etanidazole derivative EF5 IV over 1-2 hours. Approximately 24-48 hours after EF5 treatment, patients undergo surgical resection or biopsy of tumor. Cohorts of 6 patients receive escalating doses of EF5 until the maximum tolerated dose (MTD) or optimal dose is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. The optimal dose is defined as the dose level at or preceding the MTD and resulting in optimal tumor-to-normal-tissue binding. Patients are followed at 28 days.
  PROJECTED ACCRUAL: A total of 18-36 patients will be accrued for this study within 12-18 months.

Eligibility: DISEASE CHARACTERISTICS: Histologically proven breast, head and neck, prostate, or cervical carcinoma or high grade (defined as grades 2 or 3) soft tissue sarcoma Sarcoma tumors must be confined to truncal or extremity locations Must have a clinical condition and physiologic status which demonstrates that the appropriate or standard initial therapy for the tumor is surgical biopsy or resection Tumors no greater than 15 cm in any diameter Hormone receptor status: Not specified
  PATIENT CHARACTERISTICS: Age: 18 and over Menopausal status: Not specified Performance status: ECOG 0 or 1 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count greater than 2,000/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin less than 2.0 mg/dL Renal: Creatinine less than 2.0 mg/dL OR Creatinine clearance greater than 50 mL/min Cardiovascular: No significant cardiac disease that would preclude the safe use of general anesthesia Pulmonary: No significant pulmonary disease that would preclude the safe use of general anesthesia Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 1 month after study No grade 3 or 4 peripheral neuropathy
  PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See Disease Characteristics

Relevance to patient case: not relevant
Patient case: 81-year-old male with Prostate cancer. Genetic variant: PTEN Inactivating. Other conditions: Hypertension, Depression.

Clinical trial: Docetaxel in Treating Patients With Stage II or Stage III Prostate Cancer

Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
  PURPOSE: Phase II trial to study the effectiveness of docetaxel in treating patients who have stage II or stage III prostate cancer.

Detailed description: OBJECTIVES: I. Determine the pathologic complete response rate to docetaxel in patients with high risk stage II or III prostate cancer. II. Determine the toxicity of this treatment in these patients. III. Correlate clinical measures of response (e.g., symptoms, physical exam, serum PSA, and endorectal MRI) with pathologic response to this treatment in these patients.
  OUTLINE: Patients receive docetaxel IV over 30 minutes weekly for 4 weeks. Treatment continues for 2-6 courses in the absence of disease progression or unacceptable toxicity.
  PROJECTED ACCRUAL: A total of 19-45 patients will be accrued for this study over 18 months.

Eligibility: DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the prostate Potential candidate for radical prostatectomy Any of the following: Clinical stage T3 patients Serum PSA at least 20 ng/mL Gleason score 8-10 Clinical T2 disease and either of the following: MRI evidence of seminal vesicle involvement Gleason 4+3 cancer with either 5 or 6 biopsies positive
  PATIENT CHARACTERISTICS: Age: 18 to 85 Performance status: CALGB 0-1 Life expectancy: Not specified Hematopoietic: WBC greater than 3,000/mm3 Hematocrit greater than 30% Platelet count greater than 100,000/mm3 Hepatic: SGOT and bilirubin normal Renal: Not specified Other: No active infection Fertile patients must use effective contraception
  PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for prostate cancer Endocrine therapy: No prior hormonal therapy for prostate cancer Radiotherapy: No prior radiotherapy for prostate cancer Surgery: See Disease Characteristics No prior surgery for prostate cancer

Relevance to patient case: not relevant
Patient case: 81-year-old male with Prostate cancer. Genetic variant: PTEN Inactivating. Other conditions: Hypertension, Depression.

Clinical trial: Randomized Study of Testosterone and Progressive Resistance Exercise in Men With Burn Injury

Summary: OBJECTIVES: I. Determine whether testosterone normalization ameliorates muscle protein hypercatabolism by increasing net protein synthesis in men with burn injury.
  II. Determine whether the effectiveness of testosterone is enhanced by stimulation of inward amino acid transport as a consequence of hyperaminoacidemia in these men.
  III. Determine whether testosterone normalization during hospitalization minimizes the need for rehabilitation by increasing net protein synthesis and preserving skeletal muscle in these men.
  IV. Determine whether testosterone normalization after hospital discharge and throughout convalescence increases muscle strength and lean body mass after burn injury by increasing net protein synthesis.
  V. Determine whether testosterone combined with progressive resistance exercise during convalescence confers added benefits on muscle protein synthesis, and in turn, lean body mass and muscle strength in these patients.

Detailed description: PROTOCOL OUTLINE: This is a randomized study. Patients are stratified according to percent of total body surface area (TBSA) burned (no more than 40% vs more than 40%).
  Patients receive standard inpatient burn care. During hospitalization, patients are randomized to one of two treatment arms:
  Arm I: Patients receive testosterone intramuscularly (IM) weekly for 2-3 weeks during hospitalization.
  Arm II: Patients receive standard care only during hospitalization.
  After hospital discharge, patients with burns covering no more than 40% of TBSA are randomized to arm III, IV, or V, whereas patients with burns covering more than 40% of TBSA are randomized to arm III or V.
  Arm III: Patients receive testosterone IM every 2 weeks for 2 months.
  Arm IV: Patients receive testosterone as in arm III. Patients perform progressive resistance (weight lifting) exercises 3 times a week for 2 months concurrently with testosterone therapy.
  Arm V.: Patients receive standard convalescence care only.

Eligibility: PROTOCOL ENTRY CRITERIA:
  --Disease Characteristics--
  Second degree or worse burn injury Percent of total body surface area burned and degree of burn(s) must be carefully quantified
  --Patient Characteristics--
  Cardiovascular: No limiting or unstable angina No myocardial infarction within the past 6 months No horizontal or downsloping ST segment depression greater than 0.2 mV and/or frequent or repetitive arrhythmias (defined as more than 10 premature ventricular contractions per minute) No hypertension that is uncontrolled by one blood pressure medication No prior arrhythmia or valvular disease requiring treatment
  Other: No history of prostate cancer or indication of an occult carcinoma, defined by PSA greater than 4.0 micrograms/L

Relevance to patient case: not relevant
Patient case: 81-year-old male with Prostate cancer. Genetic variant: PTEN Inactivating. Other conditions: Hypertension, Depression.

Clinical trial: CT Scans in Guiding the Treatment of Patients With Prostate Cancer Who Are Undergoing Radiation Therapy

Summary: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Multiple CT scans may improve the accuracy of radiation therapy for prostate cancer.
  PURPOSE: Phase I trial to study the effectiveness of multiple CT scans in guiding the treatment of patients who have prostate cancer and are undergoing radiation therapy.

Detailed description: OBJECTIVES:
  -  Compare the accuracy of radiotherapy delivery using multiple CT scans to guide patient positioning vs the standard portal image guided procedure in patients with prostate cancer undergoing external beam radiotherapy.
  -  Determine the reduction in the proportion of patients with large target positioning errors using the CT-guided procedure.
  -  Determine organ motion and setup errors over the course of radiotherapy in order to develop efficient clinical intervention strategies in these patients.
  OUTLINE: Patients undergo radiotherapy over 9 weeks. Patients undergo a CT scan immediately prior to receiving radiotherapy on treatment days 3-8 and then weekly thereafter. On 3 different days, patients also undergo CT scan immediately after radiotherapy. If the CT scans indicate a correction that exceeds the action level currently in effect, then beginning with the next treatment, the patient's position with respect to the radiation field is adjusted.
  PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study within 2 years.

Eligibility: DISEASE CHARACTERISTICS:
  -  Undergoing external beam intensity-modulated radiotherapy for prostate cancer
  -  Able to maintain treatment position for about 40 minutes
  PATIENT CHARACTERISTICS:
  Age:
  -  Not specified
  Performance status:
  -  Not specified
  Life expectancy:
  -  Not specified
  Hematopoietic:
  -  Not specified
  Hepatic:
  -  Not specified
  Renal:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  Not specified
  Chemotherapy:
  -  Not specified
  Endocrine therapy:
  -  Not specified
  Radiotherapy:
  -  See Disease Characteristics
  Surgery:
  -  Not specified

Relevance to patient case: not relevant
Patient case: 81-year-old male with Prostate cancer. Genetic variant: PTEN Inactivating. Other conditions: Hypertension, Depression.

Clinical trial: Doxercalciferol Before Surgery in Treating Localized Prostate Cancer

Summary: RATIONALE: Doxercalciferol may be an effective way to treat localized prostate cancer before surgery.
  PURPOSE: Randomized phase II trial to study the effectiveness of giving doxercalciferol before surgery in treating patients who have localized prostate cancer.

Detailed description: OBJECTIVES:
  -  Determine whether doxercalciferol modulates intermediate endpoint biomarkers in the development of prostate cancer in patients with localized prostate cancer.
  -  Assess the toxicity of this drug in these patients.
  OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to one of 2 arms.
  -  Arm I: Patients receive doxercalciferol once daily for 28 days. Patients then undergo prostatectomy.
  -  Arm II: Patients undergo observation for 28 days. Patients then undergo prostatectomy.
  PROJECTED ACCRUAL: A total of 60 patients (30 per arm) will be accrued for this study within 18 months.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically or cytologically confirmed localized adenocarcinoma of the prostate
  -  Candidate for prostatectomy
  PATIENT CHARACTERISTICS:
  Age:
  -  21 and over
  Performance status:
  -  Not specified
  Life expectancy:
  -  Not specified
  Hematopoietic:
  -  WBC at least 4,000/mm^3
  -  Platelet count at least 100,000/mm^3
  Hepatic:
  -  Bilirubin no greater than 1.4 mg/dL
  -  AST no greater than 3 times normal
  Renal:
  -  Creatinine no greater than 2.0 mg/dL
  -  Calcium no greater than 10.2 mg/dL
  -  No idiopathic urinary calcium stone disease
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  Not specified
  Chemotherapy:
  -  Not specified
  Endocrine therapy:
  -  No prior hormonal therapy for prostate cancer
  -  No concurrent hormonal therapy, including luteinizing hormone-releasing hormone agonists, antiandrogens, glucocorticoids, ketoconazole, finasteride, diethylstilbestrol, or progestins
  Radiotherapy:
  -  No prior brachytherapy or external beam radiotherapy for prostate cancer
  Surgery:
  -  See Disease Characteristics
  Other:
  -  At least 7 days since prior vitamin D therapy or calcium supplements
  -  No other concurrent vitamin D analogues or calcium supplements
  -  No concurrent magnesium-containing antacids
  -  No concurrent thiazide-containing diuretics
  -  No concurrent phenytoin, phenobarbital, glutethimide, digoxin, or digitalis

Relevance to patient case: not relevant
Patient case: 81-year-old male with Prostate cancer. Genetic variant: PTEN Inactivating. Other conditions: Hypertension, Depression.

Clinical trial: Follow-Up Study for Men Diagnosed With Prostate Cancer Through Participation in a Prostate Specific Antigen Screening Program

Summary: There is controversy concerning the preferred treatment for men with localized prostate cancer with regard to the relative effectiveness of different treatments in controlling the cancer and how different treatments affect the patient's quality of life. The purpose of this research is to describe the disease course of prostate cancer and to determine the effectiveness, potential complications, and quality of life after different treatments in men with prostate cancer detected via screening with prostate-specific antigen (PSA) and/or digital rectal examination


Eligibility: Men with prostate cancer diagnosed through the PSA screening study

Relevance to patient case: not relevant
Patient case: 81-year-old male with Prostate cancer. Genetic variant: PTEN Inactivating. Other conditions: Hypertension, Depression.

Clinical trial: A Study of Atrasentan in Men With Metastatic, Hormone-Refractory Prostate Cancer

Summary: This study is being done to evaluate the safety and efficacy of atrasentan in men with metastatic hormone-refractory prostate cancer.


Eligibility: Inclusion Criteria:
  -  Diagnosis of prostate cancer.
  -  Rising PSA while on hormonal therapy or following surgical castration.
  -  Documented evidence of metastatic disease.
  Exclusion Criteria:
  -  Have received cytotoxic chemotherapy.
  -  Have received opioid or narcotic medications (such as codeine or morphine) or radiation for pain caused by your prostate cancer in the last 6 months.

Relevance to patient case: not relevant
Patient case: 81-year-old male with Prostate cancer. Genetic variant: PTEN Inactivating. Other conditions: Hypertension, Depression.

Clinical trial: Study of Health Promotion in Patients With Early-Stage Breast or Prostate Cancer

Summary: RATIONALE: Telephone counseling by a nutritionist and a personal trainer may improve physical function and quality of life in patients who have early-stage breast cancer or prostate cancer.
  PURPOSE: Randomized clinical trial to compare the effectiveness of a home-based, diet and exercise-based counseling program with that of a standard home-based counseling program in promoting health in patients who have early-stage breast cancer or prostate cancer.

Detailed description: OBJECTIVES:
  -  Compare the efficacy of a diet and exercise-based home-based counseling program versus a standard home-based counseling program for improving physical function at 6 and 12 months for patients with early-stage breast or prostate cancer.
  -  Compare the effects of these home-based programs on diet quality, physical activity, weight status, depression, and quality of life of these patients.
  -  Compare the factors, such as gender, race, and social support, that interact with these home-based programs to predict program efficacy in these patients.
  OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 arms.
  -  Arm I: Patients receive home-based telephone counseling by a personal nutritionist and a personal trainer.
  -  Arm II: Patients receive home-based standard health telephone counseling in unrelated areas of cancer care (e.g., sun exposure, screening, and falls prevention).
  In both arms, counseling continues every 2 weeks for 6 months.
  Patients are followed at 6 months.
  PROJECTED ACCRUAL: A total of 420 patients (210 per arm) will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of early-stage breast or prostate cancer within the past 18 months
  -  Dietary and physical activity habits and baseline functional status that places patient at risk
  -  Potentially able to increase physical activity and to follow a low-fat, plant-based diet
  -  Hormone receptor status:
  -  Not specified
  PATIENT CHARACTERISTICS:
  Age:
  -  65 and over
  Sex:
  -  Male or female
  Menopausal status:
  -  Not specified
  Performance status:
  -  Not specified
  Life expectancy:
  -  Not specified
  Hematopoietic:
  -  Not specified
  Hepatic:
  -  Not specified
  Renal:
  -  Not specified
  Other:
  -  Able to speak and write English
  -  No other malignancy within the past 5 years except nonmelanoma skin cancer
  -  No other illness or condition that would preclude adherence to a plant-based diet or exercise
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  Not specified
  Chemotherapy:
  -  Not specified
  Endocrine therapy:
  -  Not specified
  Radiotherapy:
  -  Not specified
  Surgery:
  -  Not specified

Relevance to patient case: not relevant