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: Evaluation of Neuroendocrine Differentiation as a Potential Mechanism of Tumor Recurrence Following Radiotherapy in Prostate Carcinoma

Summary: This is a pilot study to test a hypothesis that a greater increase in serum chromogranin A (CgA) after a definitive radiotherapy (RT) with or without androgen deprivation therapy (ADT) is associated with a higher risk of prostate cancer recurrence after RT. Serum CgA level is measured before the start of RT and/or the start of neoadjuvant ADT for patients undergoing a definitive RT with or without ADT. CgA is also measured at various pre-defined post-RT time points. The study will analyze the followings: 1. Change in CgA level at various pre-defined post-RT time points from the baseline, 2. Correlation between the extent of post-therapy CgA change and Gleason score of malignancy, 3. Correlation between the extent of post-therapy CgA change and treatment outcome.

Detailed description: Neuroendocrine differentiation (NED) in prostate cancer is a well-recognized phenotypic change by which prostate cancer cells transdifferentiate into neuroendocrine-like (NE-like) cells. Accumulated evidences have suggested that the prevalence of NE-like cells is associated with disease progression and poor prognosis.
  NED can be induced by a therapeutic agent. Such therapeutic agents include RT and ADT. RT-induced NED represents a novel pathway by which prostate cancer cells survive radiotherapy and contribute to treatment failure and tumor recurrence. Chromogranin A is the serum biomarker for NED and correlates well with CgA-positive staining in biopsy specimens. It has been reported that elevated serum CgA is associated with poor therapeutic response, androgen-independent growth, and biochemical recurrence.
  The study tests whether the extent of serum CgA increase by RT +/- ADT, which reflects radiation-induced NED, is correlated with the risk of prostate cancer recurrence following RT and a Gleason score of prostate carcinoma.

Eligibility: Inclusion Criteria:
  -  Clinically localized prostate carcinoma, T1-T4 N0M0, any Gleason Score, any prostate-specific antigen (PSA), or Biochemical relapse with clinically suspicious (based on MRI or clinical examination) or biopsy-proven local recurrence in the prostatic fossa after a radical prostatectomy
  -  ≥18 years old
  -  Histologic diagnosis of prostate adenocarcinoma
  -  Signed informed consent
  Exclusion Criteria:
  -  Biochemical relapse alone without clinically suspicious (i.e. no suspicious lesion on MRI of the prostatic bed) or biopsy-proven local recurrence in the prostatic fossa
  -  Regional pelvic node metastasis (N1)
  -  Distant metastasis (M1)
  -  Concurrent or previous cytotoxic medications
  -  Medical or psychological conditions that in the opinion of the investigator would not allow follow-up

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 ELIGARD® in Hormone-dependent Prostate Cancer Patients

Summary: The objective of this study is to evaluate the safety, efficacy, and impact on quality of life (QoL) of ELIGARD® in hormone-dependent prostate cancer patients in Asia.


Eligibility: Inclusion Criteria:
  -  A patient for whom the physician has decided to initiate treatment with a Luteinizing Hormone Releasing Hormone (LHRH) agonist in standard clinical practice
  -  Biopsy-proven prostate adenocarcinoma
  -  Locally advanced prostate cancer with biochemical relapse radical prostatectomy or radiotherapy.
  -  Hormonal treatment-naive advanced or metastatic prostate cancer patient who has not received chemotherapy and has no plans to undergo treatment with chemotherapy at study entry.
  -  Patient who indicates that once the study is completed, he expects having access to androgen deprivation therapy (ADT), either medical or surgical, within the local healthcare system (either through public/ private health insurance or out of pocket payment).
  Exclusion Criteria:
  -  Patient with castrate resistant prostate cancer
  -  Patient who previously underwent bilateral orchiectomy
  -  Patient who has received prior treatment with LHRH analogues
  -  Prior or concomitant treatment with systemic chemotherapy. A patient where there is a likelihood to receive systemic chemotherapy should not be enrolled
  -  Life expectancy of < 1 year due to comorbidities
  -  Participation in another interventional clinical trial within one month prior to study entry or during the duration of the study
  -  Patient who plans to receive intermittent ADT at the time of study entry
  -  Patient receiving non-palliative radiotherapy within 3 months prior to study entry
  -  Patient receiving adjuvant ADT in combination with definitive radiotherapy
  -  Patient with metastatic hormonal treatment-naive prostate cancer, for whom chemo-hormonal treatment (combination of Docetaxel and ADT) is indicated.
  -  Patient with hypersensitivity to gonadotropin releasing hormone (GnRH), GnRH agonist analogs or any of the components of ELIGARD®
  -  Patient with any contraindication for ELIGARD® use based on local prescribing information

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: Feasibility Study of Ultrasound Elastography Detecting Prostate Cancer

Summary: The main purpose of this study is to determine the accuracy and feasibility (possibility) of Aixplorer® ShearWave Elastography (SWE™) Ultrasound System (made by SuperSonic Imagine, Inc.) for detecting prostate cancer in men undergoing radical prostatectomy.

Detailed description: The point estimate and its 95% confidence interval will be calculated using the exact binominal method. Identification of suspicious cancer tissue in a 12 prostate zone schema: Participants will undergo USE: Aixplorer® ShearWave Elastography (SWE™), (SuperSonic Imagine). Areas of the prostate with high suspicion for harboring cancer will be recorded in a 12 zone prostate schema. For study purposes the prostate will be divided into Zone 1(Left Lateral Base), Zone 2 (Left Base), Zone 3 (Right Base), Zone 4 (Right Lateral Base), Zone 5 (Left Lateral Mid), Zone 6 (Left Mid), Zone 7 (Right Mide), Zone 8 (Right Lateral Mid), Zone 9 (Left Lateral Apex), Zone 10 (Left Apex), Zone 11 (Right Apex), Zone 12 (Right Lateral Apex).

Eligibility: Inclusion Criteria:
  -  Men with prostate cancer who elect surgery as the primary treatment of their cancer and to be performed at the Moffitt Cancer Center.
  -  Biopsy confirmed prostate cancer with at least ten biopsies performed for diagnosis.
  -  Location of cancer specified in the pathology report.
  -  Pathology reviewed by Moffitt pathologist
  Exclusion Criteria:
  -  Less than ten biopsies obtained at time of diagnosis.
  -  Location of cancer not specified.
  -  Pathology not reviewed by Moffitt pathologist.

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: Olive Oil v Prostate Cancer Foundation Diet for Treatment of Prostate Cancer

Summary: This study compared a plant-based, olive oil diet to the diet recommended by the Prostate Cancer Foundation for weight loss and improvement in some laboratory biomarkers.

Detailed description: Dietary treatment of overweight/ obese men with prostate cancer has not been well studied. As men with prostate cancer who are overweight/ obese are at an increase risk of recurrence, metastasis and mortality, elucidating a diet that will both improve biomarkers for prostate cancer and lead to long-term weight management could improve survivorship. The primary objective of this proposal is to compare a plant-based, olive oil (PBOO) diet to a conventional diet for weight loss and improvement in metabolic biomarkers (specifically fasting insulin, glucose, and triglycerides) for overweight/ obese men diagnosed with prostate cancer on surveillance or who have had an asymptomatic biochemical failure after primary therapy. The secondary objective is to determine which diet will be more acceptable for long term use. Participants will consume for 8 weeks each a conventional diet for treating prostate cancer and a PBOO diet for weight loss and improvement in biomarkers with random assignment to the diet order. They will choose one of the diets for 6 months of follow-up. Blood samples and body weight will be obtained pre- and post diet and after 6 months of follow-up and compared between the diets. Based on earlier work by colleagues of the PI, it is anticipated that the PBOO diet will result in better weight loss and biomarkers and will be more acceptable for long-term weight management. This protocol has the potential to elucidate a diet that will improve the body weight and survival of men with prostate cancer.

Eligibility: Inclusion Criteria:
  -  prostate cancer, BMI 25.0 to 40.0 kg/m2
  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: Prostatic Artery Embolization for Benign Prostatic Obstruction

Summary: The aim of this study is to investigate the safety and efficacy of prostatic artery embolization (PAE) for patients who refuse or are not eligible for surgery with moderate-severe lower urinary tract symptoms or indwelling catheter secondary to benign prostate obstruction due to benign prostatic hyperplasia.

Detailed description: This is a prospective study investigating the safety and efficacy of PAE for patients who refuse or are not eligible for surgery and who suffers from moderate-severe lower urinary tract symptoms or indwelling catheter secondary to benign prostatic obstruction due to benign prostatic hyperplasia. It may form the grounding for further research in the shape of a larger randomised clinical trial.
  Our hypothesis is that PAE will eliminate the need for indwelling catheter and improve IPSS 12 months post-procedure.
  1, 3, 6, 9 and 12 months follow-up.
  Main outcome Ability to void after removal of indwelling catheter
  Secondary outcomes DAN-PSS International Prostate Symptom Score (IPSS) Quality of Life (QoL) International Index of Erectile Function (IIEF) Prostate volume Peak void flow (Qmax) Post-void residual (PVR) Classify complications according to Society of Interventional Radiology (SIR) guidelines for reporting Prostate-specific antigen (PSA)

Eligibility: Inclusion Criteria:
  -  Indwelling catheter secondary to benign prostatic hyperplasia (BPH) or
  -  Moderate-severe Obstructive LUTS secondary to BPH refractory to medical treatment
  -  Unsuitable for TURP or refuse surgery
  Exclusion Criteria:
  -  Bladder dysfunction(and known neurological conditions affecting bladder function)
  -  Urethral strictures
  -  Bladder neck contracture
  -  Known sphincter anomalies
  -  Big bladder diverticulum or stones
  -  Kidney insufficiency (eGFR < 45)
  -  Coagulation disturbances
  -  Severe atheromatous or tortuosity of arteries
  -  Allergy to contrast medium
  -  Unable to undergo MR imaging
  -  Urological malignancy

Relevance to patient case: not relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: Combination Chemotherapy in Patients With Zollinger-Ellison Syndrome and Tumors of the Pancreas

Summary: Patients with Zollinger-Ellison Syndrome suffer from ulcers of the upper gastrointestinal tract, higher than normal levels of gastric acid, and tumors of the pancreas known as non-beta islet cell tumors.
  Prior to the use of drugs to cure the ulcers, patients typically died due to severe ulcers. Because of such effective drugs to treat the ulcers it is more common to see patients dying due to the pancreatic tumors.
  The study will observe patients suffering from Zollinger-Ellison Syndrome and non-beta islet cell tumors and determine the effectiveness of combined chemotherapy with streptozotocin, 5-fluorouracil, and doxorubicin.

Detailed description: Heretofore morbidity and risk of death in Zollinger-Ellison syndrome were caused by severe ulcer disease. The advent of specific drugs to cure ulcer disease now extends life until metastases from the non-beta-islet cell tumor cause death. The present study proposes to continue to test the effect of combined chemotherapy with streptozotocin, 5-fluorouracil and doxorubicin in biopsy-proven cases of metastatic non-beta-islet cell tumor in patients with Zollinger-Ellison syndrome. We published our initial experience with this protocol in 1988. An objective response was observed in 40% of patients.

Eligibility: INCLUSION CRITERIA
  Subjects selected for this study will be patients with Zollinger-Ellison syndrome who are being evaluated under the protocol entitled "Diagnostic Evaluation of Patients with Suspected Abnormalities of Gastric Secretion" (80-DK-0123).
  Histologically proven gastrinoma;
  Evidence of metastatic disease or locally invasive tumor by angiography, ultrasound, computerized axial tomography, MRI scan or bone scan;
  Progression of the tumor during the preceding 6 months.
  EXCLUSION CRITERIA
  The following pre-existing conditions will exclude patients from the study:
  Congestive heart failure;
  Proteinuria greater than 1 gram/day;
  Serum creatinine greater than 1.5 mg%;
  Platelet count less than 100,000/mm3;
  White blood count less than 2500/mm3;
  Pregnancy.

Relevance to patient case: not relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: Treatment of Zollinger-Ellison Syndrome

Summary: In patients with Zollinger-Ellison Syndrome the level of gastric acid is elevated. This increased level of gastric acid is what causes the symptoms of the disease. Certain types of medication can control the secretion of gastric acid. In this study there are details on how drugs known as antihistamines (H2 receptor antagonists) can control the levels of gastric acid secretion.
  The study describes; which patients are candidates for this research, what to do prior to initiating treatment, and the appropriate dose of antihistamine to be given.
  Initial doses of the medication will be given intravenously (injected through a vein) and later doses will be administered orally (by mouth).
  By following the procedure, researchers will be able to determine if there is a more effective route of drug administration, as well as the effectiveness of antihistamines in patients treated surgically for Zollinger-Ellison pancreatic tumors with mildly elevated gastric acid levels.

Detailed description: This protocol describes the use of histamine H2-receptor antagonists to control gastric acid hypersecretion in patients with Zollinger-Ellison syndrome. It details which patients will be considered for treatment with these agents, the pretreatment procedures and the procedures to be followed in establishing the proper intravenous dose of histamine H2-receptor antagonist. It also details the procedure to be used to establish a safe and effective oral long-term maintenance dose of either cimetidine, ranitidine, nizatidine, or famotidine. By following these procedures it will be possible to evaluate the effectiveness of intravenous histamine H2 therapy if it is determined this is important for antisecretory control during periods when patients cannot take oral gastric antisecretory agents. It will also be possible to evaluate the effectiveness of histamine H2-receptor in patients with Zollinger-Ellison syndrome after successful gastrinoma resection who continue to have mild gastric hypersecretion.

Eligibility: -  INCLUSION CRITERIA:
  Basal gastric acid secretion of greater than 15 mEq/hr (normal less than 10) or greater than 5 mEq/hr if they have had a previous gastric resection, a fasting plasma concentration of immunoreactive gastrin of greater than 100 pg/ml (normal less than 100), a positive secretin provocative tests or histological diagnosis of gastrinoma.

Relevance to patient case: not relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: A Phase I Trial of Gemcitabine and Radiation in Locally Advanced Unresectable Cancer of the Pancreas

Summary: Radiotherapy plus Single-Agent Chemotherapy/Radiosensitization. Involved-field irradiation using 4-15 MV photons; plus Gemcitabine, NSC-613327.

Detailed description: This is a Phase I trial of gemcitabine given weekly as a 30 minute infusion administered concurrently with radiation in patients with locally advanced or locally recurrent pancreatic carcinoma. Patients will be treated with external beam radiation therapy in a standard manner. Gemcitabine will be administered as a 30 minute infusion beginning on the first day of irradiation and weekly afterwards for a total of 5 doses. Patients will be assessed clinically for acute toxicity which will be graded per RTOG and DCT toxicity grading system.

Eligibility: DISEASE CHARACTERISTICS:
  Histologically or cytologically proven unresectable adenocarcinoma of the pancreas or ampulla of Vater. Surgical consult at NCI confirming unresectability fulfills requirement.
  Unresectable disease defined as tumor with: Gross involvement of regional nodes or direct extension to any of the following sites: Duodenum, Spleen, Bile duct , Colon, Peripancreatic tissue, Adjacent large vessels, Stomach.
  Metastatic disease requiring local radiotherapy allowed. No CNS metastasis.
  No lymphomas or neuroendocrine tumors.
  No peritoneal carcinomatosis.
  PRIOR/CONCURRENT THERAPY:
  Biologic Therapy: More than 4 weeks since immunotherapy.
  Chemotherapy:
  No prior chemotherapy for newly diagnosed disease.
  More than 4 weeks since chemotherapy for recurrent disease (6 weeks since nitrosoureas, mitomycin, or suramin).
  Endocrine Therapy: More than 4 weeks since hormonal therapy.
  Radiotherapy:
  No prior radiotherapy for newly diagnosed disease.
  No prior abdominal or pelvic radiotherapy.
  More than 4 weeks since radiotherapy for recurrent disease. No prior radiotherapy for locally advanced disease after resection allowed.
  Surgery:
  Prior resection allowed.
  Biliary decompression or gastric bypass allowed.
  PATIENT CHARACTERISTICS:
  Age: 18 and over.
  Performance status: ECOG 0-2.
  Hematopoietic:
  ANC greater than 2,000/mm(3).
  Platelets greater than 100,000/mm(3).
  Hepatic: AST/ALT no greater than 2.5 times normal.
  Renal:
  Creatinine less than 1.5 mg/dL.
  Creatinine clearance at least 60 mL/min,
  Cardiovascular:
  No myocardial infarction within 6 months.
  No unstable angina.
  No congestive heart failure (NYHA class III/IV).
  OTHER:
  HIV seronegative.
  No medical or psychiatric contraindication to protocol therapy.
  No concurrent malignancy other than: Skin cancer, Cervical carcinoma in situ.
  No pregnant or nursing women.
  Adequate contraception required of fertile patients.

Relevance to patient case: not relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: Radiation Therapy Plus Chemotherapy in Treating Patients With Pancreatic Cancer

Summary: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy combined with chemotherapy may kill more tumor cells.
  PURPOSE: Phase II trial to study the effectiveness of brachytherapy followed by external-beam radiation therapy plus chemotherapy in treating patients who have pancreatic cancer that cannot be removed surgically.

Detailed description: OBJECTIVES:
  -  Determine the response/remission rate, survival, and degree of local control from interstitial colloidal phosphorus P32 followed by external beam radiotherapy and chemotherapy in patients with unresectable pancreatic cancer.
  OUTLINE: Patients are stratified according to prior therapy (yes vs no).
  Patients receive dexamethasone intratumorally, then macroaggregated albumin and interstitial phosphorus P32 intratumorally. Most patients receive a second course of this brachytherapy.
  Patients then proceed to chemoradiotherapy beginning 7-14 days after brachytherapy. Radiotherapy is administered 5 days a week for 6.4 weeks. Fluorouracil IV is administered every other day for 4 doses during weeks 1 and 2.
  Patients are followed monthly for 1 year then every 3 months thereafter.
  PROJECTED ACCRUAL: A total of 48 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically proven unresectable adenocarcinoma of the pancreas limited to the head, body, or tail of the pancreas
  -  Diameter no greater than 5 cm
  -  Volume no greater than 66 mL
  -  No ascites (with or without tumor cells)
  -  No endoscopically proven tumor penetration of duodenum or stomach
  PATIENT CHARACTERISTICS:
  Age:
  -  18 and over
  Performance status:
  -  Karnofsky 70-100%
  Hematopoietic:
  -  WBC at least 3,000/mm3
  -  Platelet count at least 100,000/mm3
  -  Hemoglobin at least 9 g/dL (transfusion allowed)
  Hepatic:
  -  No hepatic disease
  -  At least 50% uptake of technetium-sulfur colloid in normal liver if cirrhosis suspected
  -  No vascular occlusion of portal system
  Renal:
  -  Creatinine no greater than 1.5 mg/dL
  -  BUN no greater than 25 mg/dL
  Other:
  -  No Crohn's disease, ulcerative colitis, or other inflammatory bowel disease
  -  Not pregnant
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  Not specified
  Chemotherapy:
  -  If prior chemotherapy, test dose of colloidal phosphorous P32 administered prior to attempted treatment
  Endocrine therapy:
  -  Not specified
  Radiotherapy:
  -  No prior radiotherapy to pancreas, liver, or upper gastrointestinal tract
  Surgery:
  -  No complete surgical resection
  -  No splenectomy

Relevance to patient case: not relevant