araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 57-year-old male with lung cancer; genetic feature: FGFR1

Clinical trial: Vistusertib (AZD2014) Monotherapy in Relapsed Small Cell Lung Cancer Patients Harboring RICTOR Amplification

Summary: [Study Design] This study is a single arm, multi-center phase II study of vistusertib monotherapy in patients with relapsed small cell lung cancer (SCLC) harboring RICTOR amplification. Patients will receive vistusertib monotherapy (50 mg BID per os every 12 hours) until they demonstrate objective disease progression or they meet any other discontinuation criteria.
  [Primary Objective] To investigate the efficacy of vistusertib monotherapy in patients with relapsed SCLC patients harboring RICTOR amplification as 2nd or 3rd line therapy


Eligibility: [Inclusion Criteria]
  -  Provision of informed consent prior to any study specific procedures
  -  Men and women aged at least 18 years
  -  Small cell lung cancer harboring RICTOR amplification
  -  Patients are willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations.
  -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 with no deterioration over the previous 2 weeks
  -  Minimum life expectancy of 12 weeks
  -  Patients must have acceptable bone marrow, liver and renal function measured within 14 days prior to administration of study treatment as defined below:
  -  At least one measurable lesion that can be accurately assessed by imaging or physical examination at baseline and follow up visits.
  -  No history of non-autologous bone marrow transplant.
  Exclusion Criteria:
  -  Participation in another clinical study with an investigational product during the last 21 days.
  -  Prior chemotherapy, biological therapy, radiation therapy, androgens, thalidomide, immunotherapy, other anticancer agents within 21 days of starting study treatment. Prior use of an investigational monoclonal antibody therapy within 3 months.
  -  Major surgery within 4 weeks prior to study entry (excluding placement of vascular access), or minor surgery (excluding tumour biopsies) within 14 days of first dose of study treatment.
  -  Exposure to strong or moderate inhibitors or inducers of CYP3A4/5, Pgp (MDR1) and BCRP if taken within the stated washout periods before the first dose of study treatment (see Appendix 1)
  -  Exposure to specific substrates of the drug transporters OATP1B1, OATP1B3, MATE1 and MATE2K within the appropriate wash-out period
  -  Any haemopoietic growth factors within 14 days prior to receiving study treatment.
  -  Pre-treatment with other PI3K, AKT, dual PI3K/mTRO and mTOR inhibitors
  -  Spinal cord compression and/or brain metastases unless asymptomatic or treated and stable off steroids for at least 4 weeks prior to start of study treatment.

Relevance to patient case: not relevant
Patient case: 70-year-old male with prostate cancer; genetic feature: PTEN

Clinical trial: Calcifidol Therapy in Men With Cancer

Summary: Prostate cancer is a common occurrence in the aging population, with one in ten men destined to develop the disease. 40% of patients with prostate cancer experience a recurrence after definitive treatment. This study addresses the as-yet unresolved problem of the optimal management of early recurrence as manifested by increase in the accepted marker for this disease, PSA. Vitamin D, an agent with cell-differentiating properties, has been shown to inhibit angiogenesis and cause differentiation of prostate cancer cells in the laboratory and to affect PSA favorably in clinical studies of patients with advanced prostate cancer. This study will assess the effects of vitamin D in patients with sub-clinical biochemical relapses of prostate cancer as indicated by rising PSA but low tumor burdens, with the potential for developing an approach to this problem that will delay or prevent progression.


Eligibility: Patients will be males with three successive rises in PSA after achieving a nadir post-definitive therapy. The following criteria must be met: pathologically confirmed prostate cancer, completion of definitive treatment in the form of local external beam radiation or definitive surgery and three successive rises in PSA with no clinical evidence of disease.

Relevance to patient case: not relevant
Patient case: 70-year-old male with prostate cancer; genetic feature: PTEN

Clinical trial: ABX-EGF (a Monoclonal Antibody) Given to Patients With Prostate Cancer With or Without Tumor in Other Parts of the Body

Summary: A clinical trial examining the safety and effectiveness of ABX-EGF when given to patients with prostate cancer with or without tumor in other parts of the body.
  Patients will be treated for a maximum of 48 doses (6 treatment courses; 8 doses per course) or until evidence of progressive disease.


Eligibility: Inclusion Criteria:
  -  Male 18 years of age or older
  -  Has tumor tissue available for diagnostics
  -  Failed front line luteinizing hormone-releasing hormone analogue (LHRH) such as leuprolide or goserelin, or failed orchiectomy, as evidenced by disease progression. Patients must continue on a LHRH analogue (unless the patient had an orchiectomy) throughout the course of the study
  -  ECOG score of 0 or 1
  Exclusion Criteria:
  -  Any prior chemotherapy for prostate cancer besides hormonal therapy (including no prior EGFr targeting agent)
  -  Prior history of cancer other than prostate carcinoma within the past 5 years that has required treatment or been active (prior basal cell carcinoma is allowed)
  -  Known to be HIV positive
  -  Myocardial infarction within one year prior to entering the study

Relevance to patient case: not relevant
Patient case: 70-year-old male with prostate cancer; genetic feature: PTEN

Clinical trial: Study of CEP-701 in Treatment of Prostate Cancer

Summary: The purpose of this study is to determine the proportion of patients with a serological prostate specific antigen (PSA) by day 85.

Detailed description: A serological PSA response is defined as a reduction from baseline PSA serum concentration of at least 50%, which is confirmed by a second PSA value 28 or more days later.

Eligibility: Inclusion Criteria:
  -  at least 18 yrs of age
  -  diagnosis of adenocarcinoma of the prostate
  -  no detectable metastatic disease as assessed by bone and CT scans
  -  has increasing serum PSA concentrations
  -  life expectancy of at least 3 months
  -  ECOG of 0 or 1
  -  has been withdrawn from antiandrogen therapy for at least 6 weeks prior to entering screening period
  Exclusion Criteria:
  -  has asymptomatic disease
  -  has active GI ulceration or bleeding
  -  has been treated with non-hormonal systemic anticancer therapy or has received radiation within 4 weeks of baseline visit
  -  bilirubin >2x ULN or ALT or AST >2xULN or serum creatinine >1.5mg/dL
  -  hemoglobin <9g/dL or platelets below 100,000/uL or ANC below 1500/uL
  -  receiving treatment for HIV with protease inhibitors
  -  has had prior malignancy within past 5 yrs with exception of resected basal or squamous cell carcinomas of the skin
  -  has used investigational drug with previous one month

Relevance to patient case: not relevant
Patient case: 70-year-old male with prostate cancer; genetic feature: PTEN

Clinical trial: Docetaxel, Radiation Therapy, and Hormone Therapy in Treating Patients With Locally Advanced Prostate Cancer

Summary: This phase I trial is studying the side effects and best dose of docetaxel when given with radiation therapy and hormone therapy in patients with locally advanced prostate cancer.

Detailed description: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high energy x-rays to kill tumor cells. Docetaxel may also make tumor cells more sensitive to radiation therapy. Androgens can cause the growth of prostate cancer cells. Drugs, such as leuprolide, goserelin, or bicalutamide, may stop the adrenal glands from making androgens. Giving chemotherapy with radiation therapy and hormone therapy may kill more tumor cells.

Eligibility: Inclusion Criteria:
  1. Histologically confirmed adenocarcinoma of the prostate with one of the prognostic factors specified in the protocol. No pelvic lymph node disease that would necessitate pelvic radiotherapy. No radiologic evidence of metastatic disease on bone scan or on CT scan or MRI of the abdomen or pelvis
  2. No prior radiation therapy, chemotherapy, immunotherapy or alternative therapy for prostate cancer. Greater than 4 weeks since any major surgery.
  3. Performance status 0-2
  4. Must meet criteria for acceptable lab values as outlined in the protocol.
  5. Peripheral neuropathy must be greater than or equal to 1
  6. Men of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter.
  Exclusion Criteria:
  1. No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with Polysorbate 80

Relevance to patient case: not relevant
Patient case: 70-year-old male with prostate cancer; genetic feature: PTEN

Clinical trial: Mathematical Modeling Analysis of Serum Prostate Specific Antigen After Radiotherapy

Summary: Clinical data are being used to build a mathematical model to describe the clinical results of radiotherapy for prostate cancer.

Detailed description: Clinical data (prostate-specific antigen [PSA] response after radiotherapy) are being used to build a mathematical model to describe the clinical results of radiotherapy for prostate cancer.

Eligibility: Inclusion Criteria:
  -  Prostate cancer treated with radiotherapy +/- hormones
  Exclusion Criteria:
  -  Prostatectomy

Relevance to patient case: not relevant
Patient case: 70-year-old male with prostate cancer; genetic feature: PTEN

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: 70-year-old male with prostate cancer; genetic feature: PTEN

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: 70-year-old male with prostate cancer; genetic feature: PTEN

Clinical trial: A Study for the Treatment of Hormone Refractory Prostate Cancer (HRPC) in Patients Previously Treated With Chemotherapy

Summary: A study for the treatment of hormone refractory prostate cancer (HRPC) in patients previously treated with chemotherapy.


Eligibility: Inclusion Criteria:
  -  Histologically or cytologically confirmed prostate cancer.
  -  Prior chemotherapy regimen for prostate cancer
  Exclusion Criteria:
  -  History of other malignancy in the last 5 years
  -  Major surgery within the past 21 days

Relevance to patient case: not relevant
Patient case: 70-year-old male with prostate cancer; genetic feature: PTEN

Clinical trial: Low-Residue Diet in Treating Diarrhea in Patients Receiving Pelvic Radiation Therapy.

Summary: RATIONALE: Eating a diet low in residue (fiber, fat, and certain milk or vegetable products) may help prevent or reduce diarrhea caused by pelvic radiation therapy.
  PURPOSE: This randomized clinical trial is studying a low-residue diet to see how well it works compared to no dietary intervention in treating diarrhea in patients who are undergoing radiation therapy to the pelvis for uterine, cervical, or prostate cancer.

Detailed description: OBJECTIVES:
  -  Compare the nutritional status, Common Toxicity Criteria (CTC) score, and fecal incontinence quality of life (FI-QOL) in patients with uterine, cervical, or prostate cancer who are undergoing pelvic radiotherapy receiving a low-residue diet vs no dietary intervention.
  -  Compare changes in the CTC score and FI-QOL in patients receiving a low-residue diet vs no dietary intervention.
  -  Compare the efficacy, in terms of a lower CTC score or higher perceived FI-QOL, of a low-residue diet vs no dietary intervention in these patients.
  OUTLINE: This is a parallel, randomized, controlled, pilot study. Patients are stratified according to cancer type. Patients are randomized to 1 of 2 treatment arms.
  All patients are interviewed to obtain a baseline grade of diarrhea (according to NCI's Common Toxicity Criteria [CTC] scale) and dietary history and measure Fecal Incontinence Quality of Life (FI-QOL).
  -  Arm I (intervention): At the onset of diarrhea symptoms, patients are instructed to eat a low-residue diet. Patients continue on this diet for 2-4 weeks. They are interviewed weekly for up to 6 weeks to monitor dietary intake, bowel symptoms, diarrhea events, FI-QOL, and changes in CTC scores.
  -  Arm II (control): Patients undergo no dietary intervention but are interviewed as in arm I.
  PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of uterine, cervical, or prostate cancer
  -  Current patient at the Ireland/Case Comprehensive Cancer Center
  -  Planning pelvic radiation therapy within the next 4 months
  PATIENT CHARACTERISTICS:
  Performance status
  -  Not specified
  Life expectancy
  -  Not specified
  Hematopoietic
  -  Not specified
  Hepatic
  -  Not specified
  Renal
  -  Not specified
  Gastrointestinal
  -  No enteric support
  -  No inflammatory bowel disease
  Other
  -  No other concurrent illness or medical condition that would preclude study compliance
  -  No history of allergies or dietary intolerances (e.g., lactose intolerance) that would preclude study treatment or interfere with study results
  PRIOR CONCURRENT THERAPY:
  Chemotherapy
  -  No concurrent chemotherapy
  Endocrine therapy
  -  Concurrent hormonal therapy allowed (e.g., testosterone suppression)
  Radiotherapy
  -  See Disease Characteristics
  Surgery
  -  No prior colectomy
  Other
  -  No concurrent glutamine, psyllium, or other fiber supplements (e.g., Benefiber^® or Metamucil^®)

Relevance to patient case: not relevant
Patient case: 70-year-old male with prostate cancer; genetic feature: PTEN

Clinical trial: Trial of Iressa in Prostate Cancer Patients

Summary: This study is being carried out to see if ZD1839 is effective in treating prostate cancer after being diagnosed with an early rising PSA (prostate specific antigen) following surgery.


Eligibility: Inclusion Criteria:
  -  Removal of prostate for prostate cancer
  -  Raised level of prostate specific antigen (PSA) post-surgery
  -  Can have received some radiation therapy
  Exclusion Criteria:
  -  Any after surgery male hormone blocking therapy.
  -  Low white blood cell count
  -  Abnormal liver function test

Relevance to patient case: not relevant
Patient case: 70-year-old male with prostate cancer; genetic feature: PTEN

Clinical trial: Combination Casodex® and Iressa™ in Locally Advanced Prostate Cancer

Summary: The purpose of this study is to determine if the addition of ZD1839 Iressa™ to standard treatment with Casodex® (bicalutamide) for locally advanced prostate cancer can detect a difference in the rate of decrease of prostate specific antigen (PSA) levels.


Eligibility: Inclusion Criteria:
  -  18 to 80 years of age. Men with histologically confirmed locally advanced prostatic adenocarcinoma
  Exclusion Criteria:
  -  No prior treatment for prostate cancer, including surgery, radiotherapy, cryotherapy or thermotherapy. No abnormal laboratory values. No co-existing malignancies and any other significant clinical disorder or laboratory finding.

Relevance to patient case: not relevant
Patient case: 70-year-old male with prostate cancer; genetic feature: PTEN

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: 70-year-old male with prostate cancer; genetic feature: PTEN

Clinical trial: Fulvestrant in Hormone Refractory Prostate Cancer

Summary: The purpose of this study is to determine if treatment with fulvestrant leads to a slowing of tumor progression in patients who have developed androgen-independent (AIPC) or hormone-refractory prostate cancer (HRPC) and who have a rising serum prostate specific antigen (PSA).

Detailed description: The purpose of this study is to determine if treatment with fulvestrant leads to a slowing of tumor progression in patients who have developed androgen-independent (AIPC) or hormone-refractory prostate cancer (HRPC) and who have a rising serum prostate specific antigen (PSA). In vitro studies have shown that fulvestrant downregulates androgen receptor (AR) in LNCaP cancer cell lines to a significant extent, thereby inhibiting growth of tumor cells. In addition, it is important to emphasize that fulvestrant has also been found to decrease growth of AR-negative prostate cancer cells. These observations provide the rational for using fulvestrant for the treatment of AIPC and HRPC.

Eligibility: Inclusion Criteria:
  -  Must give signed written informed consent
  -  Must be of age 18 years or older
  -  Histologically confirmed adenocarcinoma of the prostate
  -  Must be currently receiving LHRH agonists and have castrate levels of testosterone or have had an orchiectomy
  -  Must have had rise in PSA despite anti-androgen withdrawal
  -  Must exhibit two consecutive rises in PSA after the last hormonal manipulation
  -  Minimum PSA > 5mg/dL
  -  KPS > 80%
  -  Up to one prior chemotherapy treatments allowed
  -  Life expectancy of greater than 6 months
  Exclusion Criteria:
  -  Concomitant hormonal therapy other than an LHRH
  -  Noncompliance
  -  Platelets less than 100 x 10e9 /L
  -  International normalization ratio (INR) greater than 1.6
  -  Total bilirubin greater than 1.5 x ULRR
  -  ALT or AST greater than 2.5 x ULRR if no demonstrable liver metastases or greater than 5.0 x ULRR in presence of liver metastases
  -  History of bleeding diathesis (ie, disseminated intravascular coagulation [DIC], clotting factor deficiency)
  -  History of long-term anticoagulant therapy (other than antiplatelet therapy)
  -  History of hypersensitivity to active or inactive excipients of fulvestrant (ie, castor oil or Mannitol)

Relevance to patient case: not relevant