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: PTEN and IGFBP-3 Correlation in Ovarian Carcinoma Invasion

Summary: We have identified insulin-like growth factor binding protein (IGFBP)-3 as an invasion suppressor gene in ovarian endometrioid carcinoma, and showed association with lower cancer migration, invasion and metastasis. Recently, a novel model of ovarian EC formation from endometriosis was reported, and PTEN was found to be a major protein involved. Inactivation of PTEN has been reported in some ovarian EC tumors and methylation was suggested as one of the major epigenetic changes. This tumorigenesis model has lots of similarity to our established invasion model. Therefore, we plan to study the important of PTEN expression in ovarian EC and if inactivation of PTEN and IFGBP-3 is through methylation. Furthermore, by studying the signal transduction pathways using PTEN and IGFBP-3 transfection, we plan to study the mutual interaction between PTEN and IGFBP-3 on the suppression of tumor invasion in ovarian EC.

Detailed description: We have successfully established an ovarian cancer cell line (OVTW-59), which was derived from an ovarian endometrioid carcinoma (EC), and have also established an ovarian EC invasion model. By using cDNA microarray and quantitative reverse-transcriptase polymerase chain reaction, we identified insulin-like growth factor binding protein (IGFBP)-3 as an invasion suppressor gene, which were associated with lower cancer migration, invasion and metastasis. Clinically, lower IGFBP-3 was found associated with significantly higher tumor grade, advanced stage and poor survival in patients with EC tumors. Furthermore, we have proved IGFBP-3 expression correlated with lower Erk activation, but with no effect on the activation of Akt. All these two signal transduction proteins have crucial roles in cancer invasion. Recently, a novel model of ovarian EC formation from endometriosis was reported, and PTEN was found to be a major protein involved. Inactivation of PTEN has been reported in some ovarian EC tumors and methylation was suggested as one of the major epigenetic changes. This tumorigenesis model has lots of similarity to our established invasion model. Therefore, we plan to study the important of PTEN expression in ovarian EC and if inactivation of PTEN and IFGBP-3 is through methylation. Furthermore, by studying the signal transduction pathways using PTEN and IGFBP-3 transfection, we plan to study the mutual interaction between PTEN and IGFBP-3 on the suppression of tumor invasion in ovarian EC.

Eligibility: Inclusion Criteria:
  Clinical diagnosis of ovarian endometrioid carcinoma
  Exclusion Criteria:
  other types of ovarian epithelial carcinoma

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: Prostate Cancer Utilities and Cost-Effectiveness Analysis

Summary: The purpose of this study is to help doctors and patients make better decisions about prostate cancer treatment. This research is being done because we do not know how patient preferences for health states related to prostate cancer affect the final treatment decision.

Detailed description: The goal of this project is to incorporate patients' preferences into a previously developed prostate cancer treatment decision-model and to understand the implications for doing so for cost-effectiveness analysis. To do this, it is first necessary to obtain patient utility scores (i.e., patient preference weights). To do this we will perform a survey of patients visiting the urology clinic to undergo prostate biopsies to validate a method of utility assessment, and understand the patients' individual evaluations of treatment-related health studies. We will also ask patients questions relating to their anxiety levels concerning the possible diagnosis of prostate cancer.

Eligibility: Inclusion Criteria:
  -  Patients undergoing prostate biopsy
  Exclusion Criteria:
  -  Women and children will be excluded, as prostate cancer occurs in men only
  -  Diagnosis of dementia

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: The Potential Use of BOLD MRI as a Noninvasive Measure of Tumor Hypoxia in Prostate Cancer

Summary: Hypoxia (low oxygen level) is know to be present in many tumors and may strongly influence the success of treatment and the progression of disease in prostate cancer. The method used to measure tumor oxygen levels in prostate cancer is to place a needle in the prostate itself through the rectum. Blood oxygen level dependent imaging (BOLD MRI) is a special MRI technique that allows indirect assessment of oxygen levels in blood. This technique is non-invasive, involving no needles. BOLD has not been applied in humans in prostate cancer. The purpose of this study is to develop a MRI-BOLD technique that allows us to non-invasively measure changes related to tumor hypoxia in prostate cancer. This technique may provide information that will be an independent predictor of patient survival, tumor recurrence and likelihood of treatment response in prostate cancer

Detailed description: Hypoxia (low oxygen level) is know to be present in many tumors and may strongly influence the success of treatment and the progression of disease in prostate cancer. The method used to measure tumor oxygen levels in prostate cancer is to place a needle in the prostate itself through the rectum. Blood oxygen level dependent imaging (BOLD MRI) is a special MRI technique that allows indirect assessment of oxygen levels in blood. This technique is non-invasive, involving no needles. BOLD has not been applied in humans in prostate cancer. The purpose of this study is to develop a MRI-BOLD technique that allows us to non-invasively measure changes related to tumor hypoxia in prostate cancer. This technique may provide information that will be an independent predictor of patient survival, tumor recurrence and likelihood of treatment response in prostate cancer

Eligibility: Inclusion Criteria:
  -  prostate cancer
  Exclusion Criteria:
  -  contraindication to MRI

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: Implant and External Radiation for Prostate Cancer With or Without Hormonal Therapy: A Prospective Randomized Trial

Summary: Determine the role of androgen deprivation therapy in high risk patients receiving 45 Gy of pelvic radiotherapy plus a Pd-103 boost and the impact of the duration of ADT in hormonally-manipulated patients.

Detailed description: In calender year 2005, 220, 000 men will be diagnosed with prostate cancer and approximately 30,000 will subsequently die of metastatic disease. Although the vast majority of men will be diagnosed with clinically localized and potentially curable disease, the selection of one local modality over another remains a focus of significant controversy within the uro-oncology community. However, patients with higher risk features are most often managed with radiotherapeutic approaches to include androgen deprivation therapy.
  Prostate brachytherapy represents the ultimate-three dimensional conformal therapy and permits dose escalation far exceeding other modalities. Following permanent prostate brachytherapy with or without supplemental external beam radiation therapy, favorable long-term biochemical outcomes have been reported for patients with low, intermediate and high risk features with a morbidity profile that compares favorably with competing local modalities (1,2).
  Several prospective randomized trials have demonstrated that androgen deprivation therapy in conjunction with conventional doses of external beam radiation therapy (65-70 Gy)results in improvement in disease-free and overall survival in patients with locally advanced prostate cancer (3,4).

Eligibility: Inclusion Criteria:
  -  High risk patients - Two to three of the following: PSA 10-30 ng/mL, Gleason score greater than or equal to 6, clinical stage greater than or equal to T2c (2002 ACJJ).
  -  CT of the abdomen and pelvis and bone scan without evidence of metastases.
  -  An enzymatic prostatic acid phosphatase must be obtained prior to randomization.
  -  A serum testosterone must be obtained prior to initiation of androgen deprivation therapy.
  -  No prior pelvic external beam radiation therapy for prostate cancer or other malignancies.
  -  No prior androgen deprivation therapy.
  -  Minimum 5 year life expectancy.
  -  No other invasive cancer diagnosis other than non-melanoma skin cancer within the last 5 years.
  Exclusion Criteria:
  -  Exclusion criteria will be limited to patients who do not meet the above eligibility criteria.

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: S0437 Long-Term Follow-Up of Patients Who Were Diagnosed With Prostate Cancer on PCPT

Summary: RATIONALE: Learning about the long-term effects of chemoprevention drugs, such as finasteride, in patients with prostate cancer may help doctors plan better treatment and follow-up care.
  PURPOSE: This clinical trial is following patients who were diagnosed with prostate cancer while undergoing treatment with either finasteride or a placebo on the Prostate Cancer Prevention Trial (PCPT).

Detailed description: OBJECTIVES:
  -  Compare the time to metastases in patients who were diagnosed with high grade or low grade prostate cancer on or before December 31, 2003 and were treated with finasteride or placebo while enrolled on the Prostate Cancer Prevention Trial (SWOG-9217).
  -  Compare the difference in time to secondary therapy after definitive therapy with radiotherapy or radical prostatectomy in these patients.
  -  Compare the difference in time to prostate-specific antigen recurrence after definitive therapy with radiotherapy or radical prostatectomy in these patients.
  -  Compare the difference in all-cause and prostate cancer mortality in these patients.
  OUTLINE: This is a multicenter study. Patients are stratified according to survival status (alive vs deceased).
  Patients provide information about their general health, prostate cancer treatment history, prostate cancer status (i.e., disease progression and metastases data), and prostate-specific antigen (PSA) test results at baseline and then every 6 months for up to 8 years. Next of kin of deceased patients are asked to release the patients' medical records in order to obtain information about the patients' prostate cancer treatment history, prostate cancer progression and metastases, PSA test results, and cause of death.
  PROJECTED ACCRUAL: A minimum of 75% of the 2,401 patients (n=1800) diagnosed with prostate cancer on PCPT are needed to have minimal power to evaluate the objectives.

Eligibility: INCLUSION CRITERIA:
  -  Randomized on PCPT
  -  Diagnosed with prostate cancer on or before December 31, 2003
  DISEASE CHARACTERISTICS:
  -  Diagnosed by either study site or central pathology review
  PATIENT CHARACTERISTICS:
  -  See inclusion criteria
  PRIOR CONCURRENT THERAPY:

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: Clinico-pathologic Correlative Study of 3T Magnetic Resonance Spectroscopy in the Localization of Prostate Cancer

Summary: We seek to develop an advanced imaging approach to identifying and localizing prostate cancer. We believe that high field MRI (magnetic resonance imaging) has the potential to do this and we will endeavor to prove this by having patients with prostate cancer pre-operatively undergo a technique called magnetic resonance spectroscopy. After surgery, the microscopic locations of cancer will be compared with the pre-operative images to assess how well the imaging technique succeeds.

Detailed description: The proposed research is enormously relevant to the clinical understanding of early prostate cancer. We propose to test to see whether characteristic patterns of invivo 3T MRSI associated metabolites can be identified in correlation with clinically active tumor reserved on histopathologic analysis of resected specimens. We also plan to demonstrate that 3T MR spectra of prostate cancer will allow for more detailed metabolic assessment with higher sensitivity, specificity and accuracy and publish results established from MR spectra using 1.5T MR units. Functional imaging (eg. molecular imaging such as this) is felt to be the clinical wave of the future for cancer imaging, and if successful, will assume a very major role in the detection, assessment, treatment planning and delivery of drugs, radiation, heat and novel therapeutics in the fight against prostate cancer.

Eligibility: Inclusion Criteria:
  -  Histologically verified prostate cancer
  -  Patient has opted for surgery
  -  Low risk prostate cancer PSA <1 0, Gleason < 7, Stage < T2b
  -  No contraindication to MR scanning
  -  No prior history of malignancy
  -  Fit for surgery
  Exclusion Criteria:
  -  Nonbiopsied lesion
  -  Intermediate or high risk prostate cancer
  -  Unfit for surgery
  -  Contraindication to MR scanning (i.e. pacemaker, aneurysm clips, claustrophobia)

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: Investigation of Protein Biomarkers of Prostate Cancer

Summary: This study is looking at biomarkers in prostate cancer.

Detailed description: 1. To establish primary culture of epithelial cells isolated from prostatectomy samples
  2. To study biomarkers in prostate cancer

Eligibility: Inclusion Criteria:
  -  Patients with 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: Identification of Risk Allels for Prostate Cancer

Summary: Identification of Risk Allels for Prostate Cancer

Detailed description: As above.

Eligibility: Inclusion Criteria:
  -  Patients with 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: A Phase I Dose-Escalation Study of BMS-641988 in Patients With Castration-Resistant Prostate Cancer

Summary: This is a Phase I Dose-Escalation Study of BMS641988 in Patients with Castration-Resistant Prostate Cancer.


Eligibility: Inclusion Criteria:
  -  Advanced castration-resistant prostate carcinoma with progressive disease
  -  At least 4 weeks must have elapsed from major surgery
  -  Patient must be available for follow-up
  -  Adequate liver and kidney function
  -  Adequate blood values
  Exclusion Criteria:
  -  Uncontrolled or significant heart disease
  -  History of seizures
  -  History of head injury, loss of consciousness, or stroke
  -  Patients undergoing alcohol withdrawal
  -  Any concurrent cancer
  -  A serious uncontrolled medical disorder or active infection
  -  Inability to swallow tablets

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: Soy Supplements in Treating Patients Undergoing Surgery for Localized Prostate Cancer

Summary: RATIONALE: Dietary supplementation with soy may keep prostate cancer from growing in patients planning to undergo surgery.
  PURPOSE: This randomized phase II trial is studying a soy supplement to see how well it works compared to a placebo in treating patients undergoing surgery for localized prostate cancer.

Detailed description: OBJECTIVES:
  Primary
  -  Compare the effect of dietary supplementation with soy vs placebo on biomarkers of cell cycle regulation, proliferation, differentiation, apoptosis, and signaling pathways in patients with localized prostate cancer scheduled to undergo radical prostatectomy.
  Secondary
  -  Compare the toxicity and side effects of these regimens in these patients.
  -  Compare the dietary patterns of these patients.
  OUTLINE: This is a prospective, randomized study. Patients are randomized to 1 of 2 treatment arms.
  -  Arm I: Patients receive oral soy supplementation daily for 4 weeks.
  -  Arm II: Patients receive oral placebo supplementation daily for 4 weeks. Patients undergo radical prostatectomy within 21 days after completion of soy or placebo supplementation.
  Blood and tissue samples are collected for biomarker analysis using immunohistochemistry.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed adenocarcinoma of the prostate
  -  Clinically localized disease
  -  Scheduled for radical prostatectomy
  -  No evidence of metastatic disease by bone scan or CT scan of the abdomen or pelvis
  PATIENT CHARACTERISTICS:
  -  ECOG performance status 0-2
  -  No evidence of active nephrolithiasis
  -  No history of hypercalcemic syndrome
  PRIOR CONCURRENT THERAPY:
  -  No prior treatment for prostate cancer, including radiotherapy, systemic chemotherapy, surgery, or investigational drugs
  -  No other concurrent dietary supplementation with soy, cholecalciferol (vitamin D), or fish oil

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: Lycopene in Treating Patients With Prostate Cancer or Benign Prostatic Hyperplasia

Summary: RATIONALE: Chemoprevention is the use of certain substances to keep cancer from forming, growing, or coming back. Eating a diet high in lycopene, a substance found in tomatoes and tomato products, may keep cancer from forming or growing. Collecting and storing samples of blood from patients with cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.
  PURPOSE: This randomized clinical trial is studying how well lycopene works in treating patients with prostate cancer or benign prostatic hyperplasia.

Detailed description: OBJECTIVES:
  -  Assess the ability of prostatic tissue to accumulate doses of lycopene in patients with prostate cancer or benign prostate hyperplasia.
  -  Determine whether the steady state level of DNA oxidation in blood and prostate tissue is responsive to lycopene dosing.
  -  Investigate the effect of lycopene dosing on the lipid peroxidation marker malondialdehyde in serum.
  -  Assess the importance of measuring multiple DNA oxidation products as biomarkers of oxidative stress and its chemoprevention.
  -  Determine the significance of DNA oxidation products in blood as an indicator of oxidative stress in the prostate.
  -  Measure prostate and blood uptake of the chemoprevention agent lycopene.
  OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are randomized to 1 of 2 treatment arms.
  -  Arm I: Patients receive oral lycopene once daily for 3 weeks.
  -  Arm II: Patients receive oral placebo once daily for 3 weeks. In both arms, patients undergo biopsy to confirm diagnosis of prostate cancer or benign prostatic hyperplasia after 3 weeks of study therapy.
  Blood samples are collected at baseline and before surgery for biomarker/laboratory studies.
  PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of 1 of the following:
  -  Prostate cancer
  -  Benign prostate hyperplasia
  -  High blood levels of prostate-specific antigen
  -  Enlarged prostate
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  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: Positive Surgical Margins Rate and EGFR Family Members Expression in Prostate Cancer Treated With Bicalutamide

Summary: Following radical prostatectomy (RP), about 20% to 40% of the patients with prostate cancer (PCa) exhibit pathological parameters which are associated with a high risk of disease recurrence. The rationale for NHT is based on the theory that androgen ablation induces PCa apoptosis which induces a regression of the primary tumor bulk before RP. However the use of NHT prior RP is highly controversial. In spite of these unenthusiastic results, the relative short time of treatment and the use of different drugs from those utilized in other trials might still to make this regimen attractive in terms of drug related side effects and effectiveness. In this regard, Bicalutamide presents unique characteristics since it work differently respect to other anti-hormonal agents by interfering on both genotropic and non-genotropic mechanisms of androgen receptor


Eligibility: Inclusion Criteria:
  -  Patients with cT2-T3a prostate cancer
  Exclusion Criteria:
  -  Men>75 years
  -  Men<18 years
  -  Prior hormonal therapy
  -  Prior radiation or chemotherapy
  -  Prior investigational agents
  -  Life expectancy > 10 years
  -  Prior malignancy within the last five years
  -  Any other serious medical or psychiatric condition

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: T-Cell Response in Patients Receiving Trastuzumab and/or Chemotherapy for HER2-Positive Solid Tumors

Summary: RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors predict how well patients will respond to treatment. It may also help the study of cancer in the future.
  PURPOSE: This laboratory study is looking at blood samples from patients receiving trastuzumab and/or chemotherapy for HER2-positive solid tumors to assess T-cell response.

Detailed description: OBJECTIVES:
  -  Assess T-cell activation in blood samples of patients receiving trastuzumab (Herceptin®) and/or chemotherapy for HER2-positive solid tumors.
  OUTLINE: Blood samples are collected from patients at baseline and on days 21, 42, and 84 of trastuzumab (Herceptin®)/chemotherapy. Patients may be contacted 3-6 months after completion of trastuzumab/chemotherapy to donate another blood specimen.
  Blood samples are examined for T-cell proliferation and intracellular cytokine production. CD8 T-cell response, HER2/neu-specific antibody titers, and skin hypersensitivity test responses are also measured.
  PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of solid epithelial tumor, including, but not limited to, the following:
  -  Breast cancer
  -  Ovarian cancer
  -  Lung cancer
  -  Uterine cancer
  -  Prostate cancer
  -  HER2/neu-positive disease by immunohistochemistry or fluorescent in situ hybridization
  -  Must be receiving trastuzumab (Herceptin®) and/or chemotherapy (e.g., paclitaxel, docetaxel, fluorouracil, or estramustine)
  PATIENT CHARACTERISTICS:
  -  Absolute neutrophil count > 1,000/mm^3
  -  Absolute lymphocyte count > 400/mm^3
  -  Platelet count > 90,000/mm^3
  -  Hemoglobin > 8 g/dL
  PRIOR CONCURRENT THERAPY:
  -  No other chemotherapy within the past 4 weeks

Relevance to patient case: possibly relevant