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: A Phase II Study of Docetaxel Plus Carboplatin in Chemonaive Hormone-Refractory Prostate Cancer (HRPC) Patients

Summary: The primary objective is to determine the efficacy of docetaxel plus carboplatin as first line treatment in patients with hormone refractory prostate cancer.

Detailed description: Docetaxel-prednisolone is the current standard in HRPC, based on 2 large randomized trials showing improved survival compared to mitoxantrone-prednisolone. Carboplatin has activity in prostate cancer and the combination of Docetaxel-carboplatin is known to be synergistic and is used with good effect in many cancers. The advantage of using this combination in prostate cancer is suported by clinical data: high response rates of docetaxel-carboplatin-estramustine (with G-CSF support) in a phase II trial (Oh, Halabi, Kelly et al. Cancer. 2003 Dec 15;98(12):2592-8), and additional effect of this combination in prior taxane failures (Oh, George, Tay. Clin Prostate Cancer. 2005 Jun;4(1):61-4). Carboplatin itself has activity and theoretically could target the more hormone resistant clones or neuroendocrine components of the tumor.(Di Sant' Agnese. J Urol. 1994 Nov;152(5 Pt 2):1927-31.) We are studying the combination of docetaxel-carboplatin both given in a weekly, low-dose fashion, without estramustine and without G-CSF. This is expected to be an effective and tolerable treatment for HRPC patients. We will be documenting (to our knowledge) for the first time in this trial the efficacy of the combination given in this particular dose and schedule.

Eligibility: Inclusion Criteria:
  1. Histologically confirmed adenocarcinoma of the prostate.
  2. At the time of enrollment, patients must have evidence of metastatic disease, with either measurable disease per RECIST criteria or non- measurable disease (i.e. positive bones scan) and PSA > 5 ng/mm3.
  3. Disease progression following androgen deprivation therapy.
  4. Progression is defined according to the PSA Working Group criteria (see 6.1.3 and 6.3).
  5. Serum testosterone levels < 50 ng/mm3 (unless surgically castrate). Patients must continue androgen deprivation with an LHRH analogue if they have not undergone orchiectomy.
  6. No use of an antiandrogen for at least 4 weeks.
  7. Have not been treated with chemotherapy before.
  8. ECOG performance status of <= 2.
  9. Laboratory criteria for entry:
  -  White blood cell (WBC) => 3000/mm3
  -  Platelets => 100,000/mm3
  -  AST < 2.5 x upper limit of normal
  -  Calculated CCT of => 40 ml/min
  10. Signed informed consent form.
  11. Age: 30 years old and above
  Exclusion Criteria:
  1. Significant peripheral neuropathy defined as grade 2 or higher.
  2. Within 4 weeks since completing external beam radiotherapy or 8 weeks since completing radiopharmaceutical therapy (strontium, samarium).
  3. Concomitant chemotherapy or investigational agents.

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: Leuprolide, Bicalutamide, and Implant Radiation Therapy in Treating Patients With Locally Recurrent Prostate Cancer After External-Beam Radiation Therapy

Summary: RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as leuprolide and bicalutamide, may lessen the amount of androgens made by the body. Implant radiation therapy kills tumor cells by placing material such as radioactive iodine directly into or near a tumor. Giving leuprolide and bicalutamide together with implant radiation therapy may kill more tumor cells.
  PURPOSE: This phase II trial is studying the side effects of giving leuprolide and bicalutamide together with implant radiation therapy and to see how well it works in treating patients with locally recurrent prostate cancer after external-beam radiation therapy.

Detailed description: OBJECTIVES:
  -  Determine the feasibility and patient tolerance of interstitial brachytherapy combined with androgen-deprivation therapy for patients with locally recurrent prostate cancer after prior external-beam irradiation.
  -  Determine the toxicity of interstitial brachytherapy combined with androgen-deprivation therapy in these patients.
  -  Determine the tumor response to interstitial brachytherapy combined with androgen-deprivation therapy in these patients.
  OUTLINE: Patients receive neoadjuvant therapy comprising leuprolide acetate intramuscularly for 3 months and oral bicalutamide once daily for 30 days, beginning on the first day of leuprolide acetate administration. Patients then undergo interstitial brachytherapy implantation with I-125. Following brachytherapy, patients receive adjuvant leuprolide acetate every 3 months for an additional 6 months.
  Quality of life is assessed at baseline and at every treatment and follow-up visit.
  After completion of study therapy, patients are followed every 3 months for 2 years, every to 4-6 months for 3 years, and then annually thereafter.

Eligibility: DISEASE CHARACTERISTICS:
  -  Biopsy-proven adenocarcinoma of the prostate
  -  Locally recurrent disease, defined by digital rectal examination and/or rising prostate-specific antigen (PSA)
  -  No evidence of nodal or distant metastasis (i.e., N0, M0) on physical examination, bone scan, or CT scan of the pelvis
  -  Clinical stage T1c-T3a disease at the time of recurrence
  -  PSA < 10 ng/mL
  -  Prostate volume by transrectal ultrasonography < 60 cc
  -  Received prior external beam radiotherapy
  PATIENT CHARACTERISTICS:
  -  ECOG performance status 0-2
  -  WBC ≥ 3,000/μL
  -  Platelet count ≥ 90,000/μL
  -  Hemoglobin ≥ 10 g/dL
  -  Alkaline phosphatase < 2 times normal
  -  AST < 2 times normal
  -  Normal prothrombin time and partial thromboplastin time
  -  No significant obstructive urinary symptoms (AUA score ≤ 16)
  -  No contraindication for general anesthesia
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics
  -  No prior transurethral resection of the prostate

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: Trial Assessing Zactima Against Placebo in Prostate Cancer Subjects Undergoing Intermittent Androgen Deprivation Hormonal Therapy

Summary: The purpose of this study is to determine whether treatment with Zactima for up to 18 months will prolong the off-treatment interval in patients who are undergoing intermittent androgen deprivation therapy.


Eligibility: Inclusion Criteria:
  -  Diagnosis of prostate cancer
  -  Prostate specific antigen (PSA) greater than or equal to 5 ng/mL
  -  Recent completion of first hormone treatment [intermittent androgen deprivation with a Luteinising hormone releasing hormone (LHRH) analogue]
  -  Screening PSA ≤1.0 ng/mL (within 6 weeks prior to study Day1)
  Exclusion Criteria:
  -  Bone or soft tissue metastases
  -  Significant cardiovascular disease including hypertension not controlled by medical therapy or history of irregular heart beats or recent heart attack

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 Coronary Heart Disease (CHD) & Heart Failure (HF) Risk in Prostate Cancer Patients, Taking Casodex or Not

Summary: A retrospective cohort study performed in the GPRD,UK. All patients with incident prostate cancer identified between 1 Jan 1999 and 31 Dec 2005 and a frequency-matched cohort of the general population will be followed- up for two outcomes; CHD including acute myocardial infarction or death from coronary heart disease and HF until Dec 31, 2006. Outcomes will be validated through requests to primary care physicians. Incidence rate´ratios of CHD and HF in the two cohorts will be calculated. In the cohort of prostate cancer the relative risk of CHD and HF associated with the use of bicalutamide compared to non-use will be estimated.


Eligibility: Inclusion Criteria:
  -  At least two years enrollment with the general practitioner
  Exclusion Criteria:
  -  Patients with cancer before start date of the 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: Quality of Life Analysis of Treatment in Patients With Prostate Cancer on Adjuvant Zoladex Therapy

Summary: This is an open label, non-interventional quality of life analysis for Zoladex treated prostate cancer patients by investigator's questionnaire


Eligibility: Inclusion Criteria:
  -  Provision of informed consent
  -  Early or locally-advanced prostate cancer patients on androgen deprivation therapy
  -  Investigators are requested to recruit patients only with at least 1 month prior Zoladex treatment.
  Exclusion Criteria:
  -  Allergy to substance of medication
  -  Prostate cancer patients with advanced disease

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: Family Care for Patients and Spouses

Summary: The purpose of this study is to determine if a family-based intervention (The FOCUS Program) can improve the long-term quality of life and other psycho-social outcomes of men with prostate cancer and their spouses.

Detailed description: The purpose of this study was to determine if a family-based intervention (The FOCUS Program) could improve the long-term quality of life and other psycho-social outcomes of men with prostate cancer and their spouse/partners. Aim 1. The first aim was to determine if the family intervention could improve several proximal clinical outcomes (less negative appraisal of illness or caregiving, less uncertainty, less hopelessness, better family communication, higher self-efficacy, and more problem-focused coping) and improve the distal clinical outcome, quality of life, in a culturally and economically diverse sample of men with prostate cancer and their spouses. Aim 2. The second aim was to test a stress-coping model designed to predict which prostate cancer patients and their spouses are at higher risk of poorer long-term quality of life.

Eligibility: Inclusion Criteria:
  -  Confirmed diagnosis of prostate cancer
  -  Willing spousal partner
  -  Speaks and understands English
  -  Mentally and physically able to participate
  -  Minimum life expectancy of 12 months
  -  Lives within 70 miles
  Exclusion Criteria:
  -  Multiple primary cancers
  -  Watchful waiting status
  -  Spouse with cancer diagnosis in previous year

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: Depiction of Prostate Cancer Treatment Alternatives in Greece

Summary: A retrospective, registry analysis of the socio-economic and demographic characteristics of patients suffering from locally advanced or metastatic prostate cancer, as well as the depiction of the therapeutic algorithms followed in the Greek clinical practice.
  -  Target Group: Patients with locally advanced or metastatic prostate cancer.
  -  The first 10 consecutive patients records that meet the entry criteria.


Eligibility: Inclusion Criteria:
  -  Patients diagnosed with Locally advanced or Metastatic Prostate Cancer after 2002.
  -  Patients that received Hormonal therapy.
  Exclusion Criteria:
  -  Males that are aged less than 18 years

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 Antioxidants on MRI Detectable Early Stage Prostate Cancer Among Men on Active Surveillance

Summary: The purpose of this study is to determine whether antioxidants (vitamin E, selenium and lycopene)can change(reduce)prostate tumor size or blood flow to the prostate as determined by MRI imaging among men on Active Surveillance.


Eligibility: Inclusion Criteria:
  -  MRI detectable prostate cancer
  -  PSA less than 15 ng/ml
  -  Gleason score <= 7
  -  Prostate cancer staging T1c or T2a
  Exclusion Criteria:
  -  Concurrent use of high-dose vitamins which include selenium, lycopene, vitamin D or vitamin E
  -  Other malignancies diagnosed or requiring treatment within the past 5 years (except superficial bladder cancer or basal cell carcinoma)
  -  Current use of Proscar or Avodart

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: TSH Receptor Mutations Among a Consanguineous Community

Summary: Resistance to thyrotropin (RTSH) is a condition of impaired responsiveness of the thyroid gland to TSH, characterized by elevated TSH, low or normal thyroid hormone levels, and hypoplastic or normal-sized thyroid gland.
  The aim of the present study was to evaluate the clinical course over time,the genotype-phenotype association and the frequency of two different TSH-receptor (TSHR) mutations in a highly consanguineous population of the town of Um-El-Fahem.

Detailed description: Resistance to thyrotropin (RTSH) is a syndrome involving reduced sensitivity to TSH. It is characterized by elevated TSH, absence of goiter (normal or hypoplastic thyroid gland) and normal to very low levels of thyroid hormones. The TSH-receptor (TSHR) gene is located on chromosome 14q31 and it consists of extracellular, trans-membrane and intracellular domains. Mutation in the TSHR may cause either gain or loss of function of the receptor. Loss-of-function mutations are autosomal-recessively inherited and lead to a spectrum of phenotypes, ranging from mild euthyroid hyperthyrotropinemia to severe congenital hypothyroidism (CH). Insensitivity to TSH depends on both the severity and location of the TSHR mutations. Since the first report of familial euthyroid hyperthyrotropinemia caused by a TSHR mutation, several cases of loss-of-function mutations of the TSHR have been reported however only a few reports on the outcome of patients affected with TSHR mutations. Whether the condition of euthyroid hyperthyrotropinemia leads to clinical hypothyroidism, remains stable or normalizes over time has yet to be elucidated. We recently described a unique novel TSHR-inactivating mutation located at the third extracellular loop that preferentially affected the inositol phosphate (IP) pathway in three sisters of Arab-Muslim decent that presented with euthyroid hyperthyrotropinemia. Further analysis of the extended family revealed additional members with TSHR syndrome phenotype carrying two different TSHR mutations. All the affected subjects live in the same town. The aim of the present study was to evaluate the clinical course over time, the genotype-phenotype association and the frequency of these two different TSHR mutations among the highly consanguineous population of the town of Um El Fahem.

Eligibility: Inclusion Criteria:
  -  Subjects belonging to extended family of the index case
  Exclusion 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: Selenium in Treating Patients With Prostate Cancer

Summary: RATIONALE: Selenium may prevent or slow the growth of prostate cancer.
  PURPOSE: This randomized phase II trial is studying how well selenium works in treating patients with prostate cancer.

Detailed description: OBJECTIVES:
  -  To investigate the ability of selenium to prevent progression in patients with adenocarcinoma of the prostate.
  -  To investigate the ability of selenium to effectively modulate biomarkers of prostate cancer.
  -  To determine if selenium modifies the progression of prostate cancer based on an analysis of initial biopsy, subsequent blood biomarkers, and urological symptoms.
  -  To further establish the safety of chronic supplementation with selenium in these patients.
  OUTLINE: Patients are stratified according to Gleason score (low vs moderate). Patients are randomized to 1 of 3 treatment arms.
  -  Arm I: Patients receive oral placebo once daily for 48 months in the absence of disease progression or unacceptable toxicity.
  -  Arm II: Patients receive low-dose oral selenium once daily for 48 months in the absence of disease progression or unacceptable toxicity.
  -  Arm III: Patients receive high-dose oral selenium once daily for 48 months in the absence of disease progression or unacceptable toxicity.
  Blood and tissue samples are collected periodically for biomarker laboratory studies. Blood samples are analyzed for levels of prostate-specific antigen, chromogranin A, alkaline phosphatase, alpha tocopherol, lycopene, and other vitamins; levels of selenium by atomic absorption spectrometry; and oxidative damage to DNA. Tissue samples are analyzed for levels of Bcl-2, p53, Ki-67, thioredoxin reductase, thioredoxin, and glutathione peroxidase by immunohistochemistry and for apoptotic index by TUNEL assay.
  Patients complete urological symptom questionnaires and other questionnaires periodically.

Eligibility: DISEASE CHARACTERISTICS:
  -  Biopsy-proven adenocarcinoma of the prostate within the past 48 months
  -  Prostate-specific antigen < 50 ng/mL
  -  Gleason score < 8
  -  Currently undergoing "watchful waiting" for prostate cancer
  -  No metastatic disease
  PATIENT CHARACTERISTICS:
  -  Life expectancy ≥ 3 years
  -  AST and ALT ≤ 1.5 times upper limit of normal (ULN)
  -  Alkaline phosphatase ≤ 1.5 times ULN
  -  Bilirubin ≤ 1.5 times ULN
  -  Creatinine ≤ 1.5 times ULN
  -  No other malignancy within the past 5 years, except nonmelanoma skin cancer
  PRIOR CONCURRENT THERAPY:
  -  No prior hormone therapy, radiotherapy, chemotherapy, or surgery for prostate cancer
  -  At least 90 days since prior and no concurrent selenium (as a dietary supplement or as part of a multivitamin) exceeding 50 mcg/day

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 Role of Endothelin in Pulmonary Hypertension

Summary: The purpose of the study is is to determine the effect, on the lung circulation, of BQ-123, an investigational compound which is not approved by the FDA.

Detailed description: Endothelin levels are increased in patients with pulmonary hypertension. We wish to compare the effect of an endothelin antagonist on pulmonary hypertension due to a variety of causes.

Eligibility: Inclusion Criteria:
  -  known diagnosis of pulmonary hypertension
  Exclusion Criteria:
  -  hypertension due to other reasons (not pulmonary)

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: Symptom Management in African-American Men With Localized Prostate Cancer

Summary: RATIONALE: Gathering information about symptom management from patients with localized prostate cancer may help doctors improve patients' quality of life.
  PURPOSE: This clinical trial is studying symptom management in African-American men with localized prostate cancer.

Detailed description: OBJECTIVES:
  -  Develop a symptom management intervention for African-American men treated for localized prostate cancer, with a particular emphasis on low health literacy men.
  OUTLINE: Participants are interviewed by the principal investigator over the phone or meet the principal investigator at the Veterans Administration prostate cancer clinic. If the interview is conducted in the clinic, it is held in a private room in the clinic.

Eligibility: DISEASE CHARACTERISTICS:
  -  Biopsy-proven localized prostate cancer
  -  Has received treatment for prostate cancer
  -  Patient self-identifies as being of African-American descent
  PATIENT CHARACTERISTICS:
  -  Able to speak and read in English
  -  Has an address in order to receive study materials by mail (a street address or post office box)
  -  Has either a telephone in order to be interviewed OR is able to meet the principal investigator at the Veterans Administration prostate clinic and be interviewed there
  PRIOR CONCURRENT THERAPY:
  -  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: Predicting the Risk of Failure in Patients Undergoing Radiation Therapy for Localized Prostate Cancer

Summary: RATIONALE: Gathering information about the Gleason score, prostate-specific antigen (PSA) level, and cancer stage from patients who have undergone radiation therapy for prostate cancer may help doctors predict how patients respond to treatment and help plan the best treatment.
  PURPOSE: This clinical trial is studying the Gleason score, PSA level, and cancer stage in predicting outcome in patients who have undergone radiation therapy for localized prostate cancer.

Detailed description: OBJECTIVES:
  -  Evaluate the value of the pre-operative Gleason score, prostate-specific antigen level, and clinical stage in predicting the risk of failure and death in patients who have undergone radiotherapy for localized prostate cancer.
  OUTLINE: This is a multicenter study.
  Patient medical records are reviewed to collect data about pre-treatment prostate biopsy, assigned Gleason score, prostate-specific antigen level, and radionucleotide bone scan.
  Patients complete a Bowel Toxicity questionnaire to assess quality of life related to acute and long-term bowel toxicity after radiotherapy.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of localized adenocarcinoma of the prostate
  -  Has undergone radiotherapy (external beam radiotherapy and/or brachytherapy) with or without hormonal therapy for adenocarcinoma of the prostate in the UCSF Radiation Oncology Department at San Francisco General Hospital or Veterans Administration Medical Center of San Francisco between 1987 and 2006
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  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: A Prospective Longitudinal Study of Health-Related Quality of Life in Men With Clinically Localized Prostate Cancer

Summary: to prospectively assess the health-related quality of life (HRQOL) changes during the first year after different treatment modalities for localized prostate cancer.

Detailed description: Quality of life is of great concern to patients considering treatment options for prostate cancer. Patients with clinically localized prostate cancer treated with active surveillance, radical prostatectomy, external radiotherapy and high intensity focused ultrasound were included. All men completed the questionnaires of Functional Assessment of Cancer Therapy-Prostate (FACT-P) (version 4), International Prostate Symptom Score (IPSS) and International Index of Erectile Function (IIEF) before treatment and 1, 3, 6, 12 months after treatment.

Eligibility: Inclusion Criteria:
  -  patients diagnosed with clinically localized prostate cancer
  Exclusion Criteria:
  -  patients with another malignancies

Relevance to patient case: not relevant