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: Triple Negative Breast Cancer and Germline Hereditary Breast and Ovarian Cancer Mutation Carrier Registry

Summary: PROGECT is a registry for patients with Triple Negative breast cancer (TNBC) or patients who have an identified germline mutations (such as a mutation on the BRCA1 or BRCA2 genes).

Detailed description: This study is being done to collect cancer-related information from patients with triple negative breast cancer and patients with hereditary genetic mutations. This information will help us better understand the link between genetic changes and cancer outcome in patients with triple negative breast cancer.

Eligibility: Inclusion criteria include:
  Triple Negative Breast Cancer
  -  ER/PR <10% and HER negative per current ASCO/CAP guidelines
  -  Stages I-IV
  -  Any age at diagnosis
  -  Patient must be within 5 years of diagnosis
  -  Eligible regardless of genetic testing status
  -  Genetic testing recommended for patients meeting NCCN and Medicare guidelines
  AND/OR
  Germline mutation Carriers
  -  Patients with deleterious or uncertain mutations in HBOC genes (BRCA, PTEN, P53, -PALB2 etc) are eligible regardless of type/site of cancer
  -  Healthy patients harboring mutations also eligible
  -  There is no time limit from the time of diagnosis of cancer and enrollment.
  -  Eligible regardless of personal history of cancer
  Exclusion Criteria include:
  Triple Negative Breast Cancer -Patient is not within five years of diagnosis
  Germline mutation Carriers:
  -Patient only carries a HBOC mutation that is classified as "polymorphism" of "favor polymorphism"

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: Carboplatin in Castration-resistant Prostate Cancer

Summary: Open label, non-randomised phase II clinical pilot study

Detailed description: Pilot Study of weekly Carboplatin in Patients with Advanced Metastatic Castration-Resistant Prostate Cancer (CRPC) and DNA repair defects

Eligibility: Inclusion Criteria:
  1. Written Informed Consent
  2. Adult patients with histological diagnosis of adenocarcinoma of the prostate.
  3. Metastatic Castration-Resistant Prostate Cancer (mCRPC)
  4. Progression after at least one taxane-based chemotherapy (or contraindication against taxanes) and at least one therapy with a newer hormonal agent (Cyp17 inhibitor or a new generation AA like enzalutamide).
  5. DNA repair defects as per central assessment
  6. Eastern Cooperative Oncology Group (ECOG) performance Status (PS) 0 - 2
  7. Progression of disease by any of the criteria listed here:
  -  PSA utilizing PCWG 2 criteria
  -  Bone scan
  -  RECIST 1.1
  8. Adequate organ and bone marrow function as evidenced by:
  -  Haemoglobin ≥8.0 g/dL
  -  Absolute neutrophil count ≥1.5 x 109/L
  -  Platelet count ≥ 100 x 109/L
  -  AST and/or ALT < 2.5 x ULN, in the presence of liver metastases: AST ≥5 x ULN, ALT <5 x ULN
  -  Total bilirubin < 2.0 x ULN (except for patients with Gilbert's disease)
  -  Creatinine Clearance ≥30ml/min
  9. Patient must agree in the biomarker studies including the fresh tumour biopsies
  Exclusion Criteria:
  1. Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product Carboplatin
  2. Prior treatment with any prior platinum based chemotherapy,
  3. Major surgery within 4 weeks prior to planned start of treatment
  4. Known brain or leptomeningeal involvement unless clinically stable and on stable dose of steroids
  5. Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
  6. Previous enrolment into the current study
  7. Active secondary malignancy that requires systemic therapy.

Relevance to patient case: not relevant
Patient case: 81-year-old male with Prostate cancer. Genetic variant: PTEN Inactivating. Other conditions: Hypertension, Depression.

Clinical trial: Prostate Cancer Stereotactic Radiotherapy

Summary: Primary purpose of the study is to develop a stereotactic radiation treatment to prostate cancer which minimizes treatment related toxicity. Movement of the prostate during a radiation therapy will be monitored by temporary implanted electromagnetic transmitter. This data will be used to define prostate marginals (PTV) for stereotactic treatment. Radiation toxicity to rectum will be reduced by using a rectum fixation during a treatment.
  Study group I (20 patients) will be treated 39 x 2 Gy and study group II (20 patients) with 20 x 3 Gy fractionation schedules. With the data collected from these groups treatment marginals to prostate will be defined and used to treat group III (40 patients) with 5 x 7.25 Gy.
  Second purpose of this study is to assess if Diffusion-weighted magnetic resonance imaging could be used to evaluate radiation treatment response in intermediate prostate cancer. Androgen deprivation therapy is not allowed in this study.

Detailed description: New local prostate cancer patients needing external radiotherapy are included into three radiation dose groups;
  Group I will be treated normal dosing (39 x 2 Gy) and study group II with hypofractionated dosing (20 x 3 Gy) and group III extreme hypofractionationated dosing. Primary goal is to develop safe and effective curative radiotherapy for these patients
  Second aim is to study Diffusion-weighted magnetic resonance image in radiation treatment response in intermediate prostate cancer.
  Patients are followed by MRI, PSA, bone scans and quality of life questionaries.

Eligibility: Inclusion Criteria:
  -  Biopsy-proven prostate Cancer
  -  One or two risk factors for intermediate prostate cancer:
  -  Gleason score 7
  -  T2b-T2c
  -  PSA 10-20 microg/l
  -  No need for androgen deprivation therapy
  -  Eligible fo MRI
  -  Radical radiotherapy
  Exclusion Criteria:
  -  Locally advanced or metastatic prostate cancer
  -  Previous RT to pelvic reason
  -  Other severe disease
  -  Previous cancer within 5 years
  -  Severe urinary symptoms at the start of the study (I-PSS over 20)
  -  Wide cavity after TURP

Relevance to patient case: not relevant
Patient case: 81-year-old male with Prostate cancer. Genetic variant: PTEN Inactivating. Other conditions: Hypertension, Depression.

Clinical trial: A Phase 1, Dose Finding Study of CC-90002 in Subjects With Advanced Solid and Hematologic Cancers

Summary: CC-90002-ST -001 is an open-label, Phase 1, dose escalation and expansion clinical study in subjects advanced, refractory solid and hematologic cancers.

Detailed description: CC-90002-ST-001 is an open-label, Phase 1, dose escalation and expansion, first in human (FIH) clinical study of CC-90002, administered by intravenous (IV) infusion, in subjects with advanced, refractory solid and hematologic cancers. The study will be conducted in two parts. Following completion of dose escalation (Part A), selected hematologic and solid tumor cohorts may be enrolled into an expansion phase (Part B).

Eligibility: Inclusion Criteria:
  1. Men and women, 18 years or older, with advanced, relapsed or refractory solid tumors, Multiple Myeloma (MM) or non-Hodgkin's lymphoma (NHL).
  2. At least one site of measurable disease in subjects with solid tumors and NHL.
  3. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
  4. Subjects must have adequate hematopoietic, liver, renal and coagulation function as assessed by specific laboratory criteria.
  5. Females and males must agree to contraceptive methods and avoid conceiving throughout the study, and for up to 8 weeks following the last dose of CC-90002.
  Exclusion Criteria:
  1. High grade lymphomas (Burkitts or lymphoblastic), plasma cell leukemia.2. High grade, rapidly proliferative solid tumors (eg, small cell lung cancer, germ cell tumors, neuroblastoma) with extensive tumor burden.
  3. Symptomatic central nervous system involvement. 4. Impaired cardiac function or clinically significant cardiac disease. 5. Prior Red blood cell (RBC) transfusion < 3 months prior to starting CC-90002.
  6. Prior autologous stem cell transplant ≤ 3 months prior to starting CC-90002. 7. Prior allogeneic stem cell transplant with either standard or reduced intensity conditioning ≤ 6 months prior to starting CC-90002.
  8. Prior systemic cancer-directed treatments or investigational modalities ≤ 5 half lives or 4 weeks prior to starting CC-90002, whichever is shorter. 9. Major surgery ≤ 2 weeks prior to starting CC-90002. 10. Pregnant or nursing females. 11. Known HIV infection. 12. Known chronic hepatitis B or C (HBV/HCV) infection. 13. Ongoing treatment with chronic, therapeutic dosing of anti-coagulants. 14. History of autoimmune hemolytic anemia or autoimmune thrombocytopenia. 15. History of concurrent second cancers requiring active, ongoing systemic treatment.

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: Comparison of Tumor Glucose Metabolism Before and After Artificial Nutrition

Summary: Evaluate the feasability to determine the difference of tumoral metabolism before and after artificial nutrition.

Detailed description: Evaluation of the feasability to determine the difference of tumoral metabolism before and after artificial nutrition. This activity will be measured with TEP/TDM 18F-FDG

Eligibility: Inclusion Criteria:
  -  VADS cancer or oesophageal cancer
  -  Evaluation by 18F-FDG PET
  -  denutrition with weight loss of 5%
  -  Artificial nutrition
  -  ECOG<2
  Exclusion Criteria:
  -  Treatment by chemotherapy, surgery unless 2 months
  -  Treatment by radiotherapy unless 4 months
  -  Capillar glycemia >12mmol/l during the PET

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: 11C- and 18F-Choline PET/MR Imaging for Prostate Cancer

Summary: This is a phase 2 study to assess the ability of 11C- and 18F-choline to detect and localize prostate cancer within the prostate gland in patients with unfavorable intermediate to high-risk prostate cancer (CAPRA 5-10). Secondary objectives will assess the ability of 11C- and 18F-choline PET/MR to detect metastatic prostate cancer within pelvic lymph nodes in patients undergoing radical prostatectomy and extended pelvic lymph node dissection, to assess the ability of 11C- and 18F-choline PET/MR to detect the specific location of metastatic prostate cancer within pelvic lymph node regions in patients undergoing radical prostatectomy and extended pelvic lymph node dissection, to determine the agreement of 11C- and 18F-choline PET imaging in the detection and localization of local and metastatic disease with other imaging techniques/methods (bone scan, CT, multiparametric 1H MRI, advanced body NaF PET/CT), and to determine the temporal distribution of 11C- and 18F-choline radiotracer in patients. The tissue uptake, retention, and clearance will be determined. An exploratory objective comparing regions of uptake from the 11C- and 18F-choline PET/MR and sentinel lymph node imaging will be performed.


Eligibility: Inclusion Criteria:
  -  Age: Patients must be ≥18 years of age
  -  Diagnosis: Patients must have a diagnosis of prostate cancer by histologic verification and a hypoechoic lesion seen on ultrasound.
  -  Disease Status: Unfavorable intermediate to high-risk prostate Cancer (CAPRA 5-10)
  -  Karnofsky Performance Status ≥70
  -  Metastatic workup: Whole Body Sodium Fluoride (NaF) PET/CT or 99mTc Bone Scan
  -  Planned to undergo radical prostatectomy and extended pelvic lymph node dissection
  -  Adequate bone marrow and organ function defined as follows:
  -  Adequate bone marrow function:
  -  Leukocytes ≥ 3,000/mcL
  -  Absolute neutrophil count ≥ 1,500/mcL
  -  Platelets ≥ 100,000/mcL
  -  Adequate hepatic function:
  -  Total bilirubin - within normal institutional limits
  -  AST (SGOT) ≤ 2.5 X institutional upper limit of normal
  -  ALT (SGPT) ≤ 2.5 X institutional upper limit of normal
  -  Adequate renal function:
  -  Creatinine - within normal institutional limits OR
  -  Creatinine clearance ≥ 60 mL/min/1.73m2 for patients with creatinine levels above institutional normal
  -  Ability to understand a written informed consent document, and the willingness to sign it
  Exclusion Criteria:
  -  Participation would significantly delay the scheduled standard of care therapy
  -  Karnofsky performance status of < 60
  -  Inadequate venous access
  -  Administered a radioisotope within 5 physical half lives prior to study enrollment
  -  Have a medical condition or other circumstances which, in the opinion of the investigator would significantly decrease the chances of obtaining reliable data, achieving the study objectives, or completing 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: Shear Wave Elastography of Prostate Cancer

Summary: Evaluation of significant Shear Wave Elastography Parameters for Prostate Biopsy and Prostate Cancer detection.

Detailed description: This Study will evaluate the Shear Wave Elastography (SWE) Parameters for Prostate Biopsy and Prostate Cancer detection.

Eligibility: Inclusion Criteria:
  -  Suspicious for prostate cancer with no pretreatment and Prostata specific Antigen (PSA) >4ng/ml or PSA velocity > 0.75 ng/ml per year or suspicious transrectal digital examination
  -  Status after external beam radiotherapy of the prostate in localized prostate cancer and suspicious for local prostate cancer recurrence
  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: Study to Evaluate the Safety and Efficacy of Everolimus, in Subjects With PIK3CA Amplification, PTEN Loss and PIK3CA Mutation Refractory Solid Tumors

Summary: This study is a single-arm, phase II study of everolimus in patients with PTEN loss ,PIK3CA mutation and PIK3CA amplification Refractory Solid Tumors .
  Everolimus 10 mg will be administered orally qd daily.
  To investigate the efficacy and safety of everolimus in patients with PTEN loss ,PIK3CA mutantion and PIK3CA amplification Refractory Solid Tumors.


Eligibility: Inclusion Criteria:
  1. Provision of fully informed consent prior to any study specific procedures.
  2. Patients must be ≥20 years of age.
  3. PIK3CA amplification, PTEN loss and PIK3CA mutation Refractory Solid Tumors that has recurred or progressed following standard therapy, or that has not responded to standard therapy, or for which there is no standard therapy.
  4. ECOG performance status 0-2.
  5. Have measurable or evaluated disease based on RECIST1.1. as determined by investigator.
  6. Adequate Organ Function Laboratory Values
  -  Absolute neutrophil count ≥ 1.5 x 109/L, Hemoglobin ≥ 9g/dL, Platelets ≥ 75 x 109/L
  -  bilirubin ≤ 1.5 x upper limit of normal AST/ALT ≤ 2.5 x upper limit of normal (5.0 X upper limit of normal , for subjects with liver metastases)
  -  creatinine ≤1.5 x UNL
  7. Patients of child-bearing potential should be using adequate contraceptive measures (two forms of highly reliable methods) should not be breast feeding and must have a negative pregnancy test prior to start of dosing.
  8. Adequate heart function.
  Exclusion Criteria:
  1. Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≤5 years.
  2. Has known active central nervous system (CNS) metastases.
  3. Has an active infection requiring systemic therapy.
  4. Pregnancy or breast feeding
  5. Patients with cardiac problem.
  6. KRAS mutation (codon 12 or 13) or BRAF mutation (V600)
  7. Any previous treatment with everolimus

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: Carbon-11 Labeled Sarcosine in Prostate Cancer

Summary: Men with and without prostate cancer will have a PET/CT scan that measures the level of the amino acid sarcosine. PET is a scanning method that uses short lived radioactivity.

Detailed description: Tissue levels of the amino acid sarcosine are elevated in prostate cancer compared to normal prostate tissues and further increased in metastases from prostate cancer. This research project is designed to test whether 11C-sarcosine (a chemical that is linked to short lived radioactivity) would be useful to detect prostate cancer in men using PET/CT imaging. The uptake and distribution of 11C-sarcosine in men with known or suspected prostate cancer will be determined and compared with results from 11C-choline PET/CT.

Eligibility: Inclusion Criteria:
  -  Males 40 years of age or older
  -  Confirmed or suspected prostate cancer and will undergo a planned tissue biopsy of the known or suspected tumor (Prostate Cancer Group 1 only)
  Exclusion Criteria:
  -  Active malignancy (except basal cell or squamous cell skin cancer) within the last 2 years
  -  Body weight > 350 lbs (158 kg)
  -  Prisoners
  -  Subject not willing or able to sign informed consent

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: European Observational Study of Enzalutamide in Metastatic Castration Resistant Prostate Cancer (mCRPC)

Summary: The purpose of this study is to evaluate the effectiveness of enzalutamide in patients with metastatic castration resistant prostate cancer (mCRPC) in the clinical practice setting as measured by time to treatment failure defined as the time from baseline (treatment initiation) to treatment discontinuation of enzalutamide for any reason including disease progression, skeletal related events, treatment toxicity, patient preference, or death.


Eligibility: Inclusion Criteria:
  -  Men with mCRPC who have been prescribed enzalutamide as part of standard clinical practice
  Exclusion Criteria:
  -  Patients with the following will be excluded from study participation in France only:
  -  Patients who have previously been treated with abiraterone acetate (Zytiga®) after docetaxel chemotherapy.
  -  Patients who have previously been treated with cabazitaxel (Jevtana®)
  -  Patients who have previously been treated with Xtandi®
  -  Patients taking part in an interventional clinical trial

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: HuMax-IL8 (Interleukin8) in Patients With Advanced Malignant Solid Tumors

Summary: A phase Ib, dose escalation, multiple dose trial with HuMax-IL8 in patients with metastatic or unresectable, locally advanced malignant solid tumors.

Detailed description: All human subjects with a diagnosis of incurable solid tumors are eligible for the dose-escalation phase of this study. This study consists of two phases, the dose-escalation phase and the expansion phase. Subjects will be treated with the study treatment until any off-treatment criteria are met. The safety and efficacy will be assessed until the end of treatment or for a maximum of 52 weeks. In addition, a separate visit will be performed at the time of disease progression if the patient has a progression between end of treatment and 52 weeks. The patients will be followed up for overall survival until the study closure. The study will be closed when all enrolled patients have been followed up for at least 52 weeks or have died.

Eligibility: Inclusion Criteria:
  -  Subjects must have metastatic or unresectable locally advanced malignant solid tumor.
  -  Patients may have measurable or non-measurable but evaluable disease.
  -  Patients with surgically resected metastatic disease at high risk of relapse are also eligible.
  -  Patients must have completed or had disease progression on at least one prior line of disease-appropriate therapy for metastatic disease, or not be candidates for therapy of proven efficacy for their disease.
  -  Patients must have recovered (grade 1 or baseline) from any clinically significant toxicity associated with prior therapy
  -  Age ≥ 18 years. .
  -  ECOG (Eastern Cooperative Oncology Group) performance status ≤ 1 (Karnofsky ≥ 70%).
  -  Patients must have normal organ and hematologic function therapy
  -  Patients must have baseline pulse oximetry > 90% on room air
  Exclusion Criteria:
  -  Pregnant women or women presently breast-feeding
  -  Concurrent treatment for cancer
  -  Chronic hepatitis B or C infection.
  -  Any significant disease that, in the opinion of the investigator, may impair the patient's tolerance of study treatment.
  -  Significant dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.
  -  Active autoimmune diseases requiring treatment or a history of autoimmune disease.
  -  Concurrent use of systemic steroids
  -  Patients who are receiving any other investigational agents
  -  Patients with untreated central nervous system metastases or local treatment of brain metastases
  -  History of allergic reactions attributed to compounds of similar chemical or biologic composition to the agent used in study.
  -  Serious or uncontrolled intercurrent illness
  -  HIV-positive patients are ineligible
  -  Patients unwilling to use adequate contraception
  Other protocol defined inclusion/exclusion criteria could apply

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 Predictive Value of Coexisting TMPRSS2-ERG Gene Fusion and PTEN Deletion in Prostate Cancer Patients With Biochemical Failure Status Post Salvage or Radical Radiation Therapy

Summary: The objective of the study is to evaluate the predictive value of TMPRSS2-ERG gene fusion and PTEN in patients with high risk prostate cancer treated with first line LHRH agonist after biochemical failure.

Detailed description: The objective of the study is to evaluate the predictive value of TMPRSS2-ERG gene fusion and PTEN in patients with high risk prostate cancer treated with first line LHRH agonist after biochemical failure.
  Patients in this study will be treated with standard hormonal treatment. Patients will remain on treatment regardless of rising PSA. PSA, other systemic therapy maybe added and the patients with oligometastasis could be treated with radiation therapy; this would be at the discretion of the treating oncologist.
  The primary endpoint of this study is to determine the predictive value of TMPRSS2-ERG gene fusion and PTEN in hormonal refractory free survival and clinical progression rate in three years. The secondary endpoints are to evaluate the relation between Gleason score and TMPRSS2-ERG gene fusion and PTEN independently and together, the relation between T stage and TMPRSS2-ERG gene fusion and PTEN independently and together, and to determine the association of these markers with overall survival.

Eligibility: Inclusion Criteria:
  -  T3a +
  -  PSA > 20
  -  Gleason 8 or higher
  -  Karnofsky performance status ≥ 70.
  -  Signed study-specific informed consent
  Exclusion Criteria:

Relevance to patient case: not relevant