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: Study of Ipatasertib or GDC-0980 With Abiraterone Acetate Versus Coralie in Participants With Castration-Resistant Prostate Cancer Previously Treated With Docetaxel Chemotherapy

Summary: This multicenter, international, Phase Ib/II trial consists of two stages: a Phase Ib, open-label stage in which the recommended Phase II dose will be determined for ipatasertib and GDC-0980 in combination with abiraterone and prednisone/prednisolone and a Phase II, 3-arm, double-blind, randomized comparison of ipatasertib with abiraterone and prednisone/prednisolone versus placebo with abiraterone and prednisone/prednisolone.


Eligibility: Inclusion Criteria:
  -  Histologically confirmed metastatic or advanced prostate adenocarcinoma that has been previously treated with docetaxel and has progressed during treatment of at least one hormonal therapy
  -  Two rising PSA levels greater than or equal to (>/=) 2 ng/mL measured >/= 1 week apart or radiographic evidence of disease progression in soft tissue or bone
  -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at screening
  -  Adequate hematologic and organ function
  -  Documented willingness to use an effective means of contraception
  Exclusion Criteria:
  -  History of Type I or Type II diabetes mellitus requiring insulin
  -  New York Heart Association Class III or IV heart failure or Left ventricular ejection fraction < 50% or ventricular arrhythmia requiring medication
  -  Significant atherosclerotic disease, as evidenced by: unstable angina, history of myocardial infarction within 6 months prior to Day 1, or cerebrovascular accident within 6 months prior to Day 1
  -  Active autoimmune disease that is not controlled by nonsteroidal anti-inflammatory drugs or active inflammatory disease which requires immunosuppressive therapy
  -  Clinically significant history of liver disease
  -  History of adrenal insufficiency or hyperaldosteronism
  -  Phase II only: Previous therapy for prostate cancer with 17 alpha-hydroxylase/C17,20-lyase inhibitors, including abiraterone
  -  Phase II only: Previous treatment for prostate cancer with Protein kinase B phosphatidylinositol 3 kinase and/or mammalian target of rapamycin inhibitors
  -  Need for chronic corticosteroid therapy of >/= 20 mg of prednisone per day or an equivalent dose of other anti inflammatory corticosteroids or immunosuppressant

Relevance to patient case: definitely relevant
Patient case: 81-year-old male with Prostate cancer. Genetic variant: PTEN Inactivating. Other conditions: Hypertension, Depression.

Clinical trial: Trial of Dasatinib in Patients With Advanced Cancers Harboring DDR2 Mutation or Inactivating B-RAF Mutation

Summary: The purpose of this study is to establish whether patients with malignancy harboring a discoidin domain receptor 2 mutation or an inactivating B-RAF mutation will respond to dasatinib.


Eligibility: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
  Inclusion Criteria:
  -  Diagnosis of advanced malignancy, nonsmall-cell lung cancer (NSCLC) only during stage 1 of accrual
  -  Nonsynonymous mutation of B-RAF or DDR2, defined as follows:
  -  NSCLC with inactivating B-RAF mutation
  -  NSCLC with discoidin domain receptor 2 (DDR2) mutation
  -  Malignancy of other histology with DDR2 mutation or inactivating B-RAF mutation, or NSCLC having a B-RAF mutation that is not functionally characterized
  -  At least 1 target lesion per Response Evaluation Criteria in Solid Tumors, vol 1.1, on baseline staging evaluation
  -  Disease progression after ≥ 1 prior treatment regimen
  Exclusion Criteria:
  -  Pleural or pericardial effusion, Grade >1
  -  QTcF >470 msec (Grade ≥2) or diagnosed congenital long QT syndrome
  -  Absolute granulocyte count <1500/mm^3
  -  Hemoglobin level <10 g/dL
  -  Platelet count < 75,000/mm^3
  -  Serum calcium level <institutional lower limit of normal
  -  Hypokalemia, hypophosphatemia, or hypomagnesemia, Grade >1, despite supplementation
  -  Creatinine >3*institutional upper limit of normal (ULN)
  -  Total bilirubin level >1.5*ULN
  -  Alanine transaminase level >3*ULN

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: Biochemical Recurrence Rate of Radical Prostatectomy Combined With Neoadjuvant and Adjuvant Chemotherapy in High Risk Prostate Cancer

Summary: Effect of Radical Prostatectomy Combined with Neoadjuvant and Adjuvant Chemotherapy in Patients with High Risk Prostate Cancer.
  The purpose of this study is to evaluate whether neoajuvant and adjuvant docetaxel and prednisone are effective in the treatment of high risk localized prostate cancer.

Detailed description: The purpose of this study is to evaluate whether neoajuvant and adjuvant docetaxel and prednisone are effective in the treatment of high risk localized prostate cancer.

Eligibility: Inclusion Criteria:
  -  Prostate Cancer
  -  PSA > 20 OR
  -  Clinical Stage > T2C OR
  -  GS > 7

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 Effect of Endurance Training in Patients With Prostate Cancer

Summary: The aim of the present study is to investigate the effect of endurance on PSA doubling time in prostate cancer patients with an elevation in PSA following radical prostatectomy for localized cancer. Furthermore, underlying mechanisms such as reduction in inflammatory markers and improvement in insulin sensitivity and body composition are investigated.


Eligibility: Inclusion Criteria:
  -  Prostate cancer patients with an increase in PSA following radical prostatectomy
  Exclusion Criteria:
  -  severe cardiovascular disease
  -  severe arthritis
  -  severe neuropathy
  -  severe hypertension
  -  therapy with antidiabetic agents
  -  other treatment for prostate cancer than radical prostatectomy

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 Diagnosis of Biliary Tract Neoplasm by Diffusion Weighted Imaging and Magnetic Resonance Cholangiopancreatography

Summary: Researching the diagnostic significance of Biliary Tract Neoplasm under combining DWI sequence with MRCP versus MRCP only separately.

Detailed description: The purpose of the study is to evaluate the usefulness of diffusion weighted imaging(DWI) combined with MRCP of 3-T magnetic resonance imaging (MRI) in the evaluation of suspected malignant bile duct diseases.People with suspected Biliary Tract Neoplasm based on clinical symptoms(such as jaundice and thinness with unknown reasons)and CA-199 value raises are included.Diagnosis divided into two steps: the first one，only provide conventional MR sequences and MRCP images to make a diagnosis; the second step,provide the DWI images additionally, combining the image data before to make a diagnosis.Hypothesis is that DWI sequence should be regularly added into MRCP examination for improving diagnosis rate of Biliary Tract Neoplasm.

Eligibility: Inclusion Criteria:
  -  Informed consent
  -  Suspected Biliary Tract Neoplasm based on clinical symptoms(such as jaundice and thinness with unknown reasons)and CA-199 raises（＞37U/mL）
  -  No evidence of clinical symptoms or CA-199 increase by non-bile duct cancerous factors(hepatitis,cholangeitis,stones)
  -  Age ≥ 16
  Exclusion Criteria:
  -  Previous Biliary Tract Neoplasm surgery
  -  Contraindication for MRI (such as pacemaker or inner ear implant)
  -  Claustrophobia
  -  Age < 16

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: Management of Prostate Cancer in Central China

Summary: Some recent reports indicate that incidence of prostate cancer is increasing rapidly in China. However, no large-scale survey of prostate cancer has been done in central China, few data are available regarding its management. The investigators aimed to analyze the management of prostate cancer and compare the outcome of patients with such a survey.
  The investigators collected data of patients diagnosed with prostate cancer from the 2003 and 2008 in central China. Data were disaggregated by rural and urban hukou. The survival rate of patients was analyzed using Kaplan-Meier method. Prognostic factors were analyzed using the log-rank test and Cox proportional hazards model.


Eligibility: Inclusion Criteria:
  -  patients with newly diagnosed prostate cancer were included in the study. Exclusion Criteria:
  -  Those with a history of prostate cancer who were treated for another disease were excluded from 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: Medical Economics of Urinary PCA3 Test for Prostate Cancer Diagnosis

Summary: The ultrasound-guided biopsies of the prostate is the validated technique for the diagnosis of prostate cancer, the first human cancer and second leading cause of cancer death. Overall, in more than half of cases, prostate biopsies performed in search of a prostate cancer are negative. In this population, there is no consensus recommendation on how to care, leading to repeated invasive biopsies, potential sources of complications.
  The PCA3 urine test (ProgensaTM, GenProbe) is an innovative diagnostic tool to predict the positivity of prostate biopsies, especially in patients who had at least one negative biopsy. Proposed in clinical practice in France as a commercial kit, it is expensive and is not covered by health insurance. It is therefore essential to assess the medical and economic impact of its introduction into medical practice.
  The investigators propose to set up a study of high standard of proof, multicenter, based on recruitment of patients treated in hospitals. This working hypothesis is that the availability of the PCA3 test results would reduce the number of invasive biopsies performed incorrectly in patients already had at least one negative biopsy, thus improving the diagnostic strategy of prostate cancer.


Eligibility: Inclusion Criteria:
  -  patients ≥ 18 year-old
  -  patients who undergo prostate biopsy for increased serum PSA and/or abnormal digital rectal examination
  -  patients who gave informed consent
  Exclusion Criteria:
  -  no informed consent
  -  medical history of or current significant prostate cancer
  -  medical history of or current extra-prostatic cancer
  -  high risk of loss of follow-up
  -  clinically obvious prostate cancer (clinical stage ≥ T3, PSA ≥ 50 ng/ml, lymph node involvement, osteolytic bone metastases)

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 to Evaluate the Safety and Efficacy of Enzalutamide in Chemotherapy-Naïve, Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer

Summary: The purpose of this study is to investigate radiographic progression-free survival (PFS) of enzalutamide in chemotherapy-naïve patients with progressive metastatic castration-resistant prostate cancer who have symptomatic disease.


Eligibility: Inclusion Criteria:
  -  Progressive prostate cancer while on androgen deprivation therapy
  -  Castrate testosterone level
  -  Maintenance of surgical or medical castration for duration of study
  -  Radiographically visible metastatic disease
  -  Symptomatic from prostate cancer
  -  Eastern Cooperative Oncology Group (ECOG) 0-2
  -  Life expectancy >=6 months
  Exclusion Criteria:
  -  Brain metastases or leptomeningeal disease
  -  Prior cytotoxic chemotherapy for prostate cancer
  -  Prior use of ketoconazole or abiraterone acetate or other investigational agent that blocks androgen synthesis or targets androgen receptor
  -  History of seizure or condition that may predispose to seizure
  -  History of loss of consciousness or transient ischemic attack within 12 months
  -  Clinically significant cardiovascular 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: A Study of PSMA ADC in Subjects With Metastatic Castration-resistant Prostate Cancer (mCRPC)

Summary: PSMA ADC 2301 is a Phase 2, open-label, study to assess the anti-tumor activity and tolerability of Prostate Specific Membrane Antigen Antibody Drug Conjugate (PSMA ADC) in two groups of subjects with metastatic castration-resistant prostate cancer (mCRPC). One group comprises subjects who must have received at least one taxane-containing chemotherapy regimen (e.g. docetaxel, cabazitaxel). The second group comprises subjects who are cytotoxic chemotherapy-naïve. Subjects who are cytotoxic chemotherapy-naïve must have received and progressed on-, be ineligible for, refused, have an intolerance to-, or not have access to Radium-223. Both groups of subjects must also have received and progressed on abiraterone acetate and/or enzalutamide. If a subject is unable to receive abiraterone acetate and/or enzalutamide, Sponsor approval is required for participation in the study. Subjects will receive up to eight doses of PSMA ADC approximately once every three weeks.


Eligibility: Inclusion Criteria:
  1. A diagnosis of metastatic castration-resistant prostate cancer.
  2. a) Prior history of treatment with at least one taxane-containing chemotherapy regimen (e.g. docetaxel, cabazitaxel). If a subject has received more than two cytotoxic chemotherapy regimens, Sponsor approval is required for study participation.
  OR
  b) No prior history of treatment with a cytotoxic chemotherapy regimen.
  3. Must have received and progressed on abiraterone acetate and/or enzalutamide. If subject is unable to receive abiraterone acetate and/or enzalutamide, Sponsor approval is required for participation in the study.
  4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
  5. Life expectancy ≥ six months.
  6. Cytotoxic chemotherapy-naïve subjects ONLY must have received and progressed on-, be ineligible for, refused, have an intolerance to-, or not have access to Radium-223.
  Exclusion Criteria:
  1. Treatment within 30 days prior to first dose of study drug of the following:
  -  External Radiation therapy
  -  Radiopharmaceuticals
  -  Cytotoxic chemotherapy
  -  Treatment with an investigational agent
  2. Clinically significant cardiac disease or severe debilitating pulmonary disease
  3. An acute infection requiring ongoing antibiotic therapy
  4. Any prior treatment with PSMA ADC or other therapies targeting PSMA, or other antibody drug conjugate (ADC) products that contain monomethyl auristatin E (MMAE) (e.g., brentuximab vedotin, glembatumumab vedotin, ASG-5ME, RG7450) unless approved by Sponsor.
  5. History of drug and/or alcohol abuse
  6. History of pancreatitis

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: Treatment of Prostate Cancer With Firmagon®

Summary: How are testosterone levels of patients with prostate cancer under treatment with Firmagon® changing.
  Former studies showed a quick fall of testosterone levels after start of therapy with Firmagon® and a quick recovery when therapy is stopped. The investigators want to prove this in a normal outpatient urologist setting. Furthermore data is collected to prove the adherence to the German S3-Guideline for the treatment of prostate cancer.


Eligibility: Inclusion Criteria:
  -  advanced hormone-dependent prostate cancer with no other previous hormone therapy for whom - irrespectively of this NIS -the use of Firmagon® is intended
  Exclusion Criteria:
  -  contraindication for Degarelix

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 Feasibility Study of an Online Intervention for Sexual Rehabilitation in Prostate Cancer

Summary: Background: Prostate cancer (PCa) is the most common cancer for men. When treated early enough it is typically curable. However, common treatments, such as radical prostatectomy and radiation therapy, often result in significant negative outcomes with regard to sexual, psychological and social function. Both men and partners have identified the need for more information and support to address sexual health concerns after treatment. However, very few sexual rehabilitation interventions have been developed and rigorously assessed.
  Purpose: The investigators propose to develop and pilot test a new program to meet the sexual health needs of men with PCa and their partners using an online, professionally facilitated education/support program. The goals of the program are to improve sexual function, intimacy and mood for men and their partners after treatment for localized PCa. The program will be offered through Cancer Chat Canada, an existing and well-tested Canadian platform for professionally facilitated support group programs.
  What Participants Can Expect: A total of 24 men and their female partners (48 individuals) will be recruited and assigned to one of two groups. The first group will participate in the program immediately; the second group will be offered the program after a 5-month delay. The decision about which group will start immediately and which later will be made randomly (by chance). Both groups of men and partners will be asked to complete questionnaires three times and, at the end of the program, to provide the researchers feedback about how satisfied they were with the program, the changes they made, things they learned as a result of the program, and suggestions for improving the program. Participants must have access to a computer, an Internet connection and be willing to attend online, chat room meetings each week for 1.5 hours for 6 weeks.
  Implications: Sexual rehabilitation is a high need for men affected by PCa, but is difficult to access. The investigators hope to improve access to sexual health care through this study.


Eligibility: Inclusion Criteria:
  -  Men who have been treated for localized prostate cancer
  -  AND men must be 6-36 months post-prostatectomy or radiation (as primary treatment) of prostate cancer
  -  Must have a heterosexual, co-cohabiting partner who is willing to participate
  -  Must speak and read English
  -  Must be able to use a computer and have internet access
  Exclusion Criteria:
  -  Homosexual couples will not be included in this study
  -  Major self-reported psychiatric illness
  -  Couples who screen below 30 on the DAS (Dyadic Adjustment Scale)

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: Impact of the Geographical FACTor on the Prostate Cancer Stage at Hormonal Therapy Initiation

Summary: French epidemiological data have shown a heterogeneous distribution of the risk of mortality from prostate cancer according to region. The main objective is to describe the distribution of prostate cancer stages when first line hormonal therapy is introduced (overall and by region).


Eligibility: Inclusion Criteria:
  -  Patients with histologically demonstrated prostatic adenocarcinoma.
  -  Patients never previously treated with hormonal therapy for prostate cancer.
  -  Patients eligible for hormonal therapy after initial consultation (alone or in combination with curative treatment).
  -  Patients agreeing to the collection of personal health data for the purposes of the study.
  -  Patients with locally advanced or metastatic prostatic cancer tumours or a biological recurrence after curative treatment.
  Exclusion Criteria:
  -  Patients participating in a clinical study involving prostate cancer at the time of inclusion in the investigation.
  -  Patients having received or currently receiving hormonal treatment for prostate cancer (surgical castration or other hormonal manipulation, including GnRH receptor antagonists, antiandrogens, oestrogens, 5 alpha reductase inhibitors).

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 ProCaRis Study: Prostate Cancer Risk Assessment in General Practice

Summary: The preferred method for early detection of prostate cancer (PCa) in older men with family history is the Prostate Specific Antigen test (PSA test), although the method is imprecise. It produces a high number of false-positive results and increases the risk of over-diagnosis and over-treatment. Yet, an increasing number of men get the PSA test as part of unsystematic screening. Genetic risk assessment may be a better way to identify men with low risk of PCa. The main study hypothesis is that genetic information about low risk of PCa can reduce the number of patients who get a PSA test as part of unsystematic screening.


Eligibility: Inclusion Criteria:
  -  patients who receive a PSA test
  Exclusion Criteria:
  -  age over 80 years
  -  elevated PSA-level (> 4,0 ng/ml) concurrently or within previous 2 years
  -  prostate or bladder disease
  -  prostate cancer
  -  non-Caucasians
  -  do not speak and understand Danish

Relevance to patient case: possibly relevant
Patient case: 81-year-old male with Prostate cancer. Genetic variant: PTEN Inactivating. Other conditions: Hypertension, Depression.

Clinical trial: Choline-PET for Evaluating the Incidence of Nodal Metastases Among Newly Diagnosed Patients of Prostate Cancer

Summary: Nodal involvement among patients with prostate cancer is known to be a poor prognostic factor. Traditionally, the presence or absence of nodal disease in patients with prostate cancer is ascertained with the use of anatomical imaging methods such as computed tomography (CT) and magnetic resonance imaging (MRI).
  However, the sensitivities of CT and MRI for the detection of pelvic nodal disease is rather low, with reports placing the value to lie between 50-80%.
  Positron emission tomography (PET) with the use of carbon-11 or fluorine-18 tagged choline (Choline-PET) is an approach which is known to deliver a high sensitivity for the imaging of prostate cancer disease burden in the primary, nodal and the metastatic areas.
  The investigators in this prospective trial intend to utilize Choline-PET among all newly diagnosed patients of prostate cancer who are presumed to be non-N1 (absence of nodal disease on conventional imaging) and non-M1 (absence of metastatic disease on conventional imaging).


Eligibility: Inclusion Criteria:
  -  Consenting patients
  -  Diagnosed prostate cancer
  Exclusion Criteria:
  -  Metastatic disease at presentation

Relevance to patient case: not relevant