araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 70-year-old male with prostate cancer; genetic feature: PTEN

Clinical trial: Copanlisib Pharmacodynamic Study

Summary: This study aims to analyze what the study drug does to the body and its relationship to drug levels and safety after patients with advanced cancer have been treated with copanlisib in different dose groups.


Eligibility: -  Histologically confirmed diagnosis of the following NHL: follicular lymphoma all grades, lymphoplasmacytic lymphoma / Waldenström macroglobulinemia, transformed indolent lymphoma, diffuse large B-cell lymphoma, Burkitt lymphoma, mantle cell lymphoma, or peripheral T-cell lymphoma, relapsed or refractory, with 1 or more prior chemo-immunotherapy- or immunotherapy-based regimen(s) OR
  -  Advanced and / or refractory solid tumors with high prevalence (≥30%) of PIK3CA or PTEN alteration: Breast and uterine cancers (endometrium cancers but also non-endometrial uterine cancers), lung (squamous cell only), cervical, head and neck, prostate, and ovarian cancers
  -  Biopsy-accessible tumor
  -  Male or female patients equal 18 or more years of age
  -  NHL patients must have at least 1 bi-dimensionally measurable lesion according to the modified Cheson criteria. Patients with solid tumors must have at least 1 solid tumor lesion measurable by computed tomography or magnetic resonance imaging according to the Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) criteria
  -  Eastern Cooperative Oncology Group performance status 2 or <
  -  Life expectancy of at least 3 months
  -  Adequate bone marrow, liver, and renal functions as assessed by laboratory requirements conducted within 7 days before the first dose of study drug
  -  Left ventricular ejection fraction > or equal the lower limit of normal for the institution
  Exclusion Criteria:
  -  Previous or concurrent cancer that is distinct in primary site or histology from NHL or the solid tumor, for which the patient is enrolled into this study, within 5 years before treatment start EXCEPT for curatively treated cervical cancer in situ, non-melanoma skin cancer, in situ breast cancer, in situ prostate carcinoma if Gleason score < or equal to 6 and prostate-specific antigen <10 ng/mL, and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor invades lamina propria)]
  -  Known lymphomatous involvement of the brain or leptomeningeal involvement; solid tumor patients with central nervous system (CNS) metastases if treatment completed <3 months before enrollment or lesions unstable or progressing on magnetic resonance imaging scans performed within 1 month of enrollment or unstable symptoms of the CNS metastases
  -  Any illness or medical condition that is unstable or could jeopardize the safety of the patient or his / her compliance in the study
  -  Current diagnosis of type 1 or type 2 diabetes mellitus with HbA1c < or equal to 8.5% or fasting blood glucose < or equal to 160 mg/dL

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

Clinical trial: Impact of a Printed Decision Aid on Patients' Intent to Undertake Prostate Cancer Screening

Summary: Although the number of recommendations against systematic screening of prostate cancer, 70% of patients still request testing because they overestimate the benefits and are unaware of the limitations.
  The investigators aim is to assess the impact of a short printed decision aid presenting benefits and limits of screening, on patients' intent to undergo prostate cancer screening.

Detailed description: A Cochrane systematic review of 5 randomized controlled trials showed that screening for prostate cancer, using digital rectal examination and dosage of prostate specific antigen (PSA), did not significantly decrease prostate cancer specific mortality. Rather, screening for prostate cancer often led to over-diagnosis by detecting tumors that would not otherwise have become symptomatic or by producing false positive results. It could therefore result in unnecessary supplementary testing (including prostate biopsies), inadequate and/or harmful treatment, and negative psychological outcomes among patients.
  Although the growing number of recommendations against PSA testing for screening of prostate cancer, 70% of patients still request testing prior to any information because they overestimate the benefits and are unaware of the limitations. As a result, about 55% of patients between 50 and 74 years old, undergo prostate cancer screening in the USA every year, despite recommendations against it.
  To help patients understand the complexities about PSA testing for prostate cancer screening, professional organizations encourage physicians and patients to use decision aids to make informed decisions.
  The aim of this study was to evaluate the impact of a decision aid, usable in daily practice by general practitioners, presenting harms and benefits of prostate cancer screening on patients' intent to undergo screening.

Eligibility: Inclusion Criteria:
  -  male patients from 50 to 75 years old
  Exclusion Criteria:
  -  personal history of prostate cancer
  -  any urinary tract symptoms
  -  history of prostate cancer in a first degree relative
  -  known exposition to chlordecone

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

Clinical trial: Metformin Prostate Cancer Adjuvant Trial

Summary: This is a Phase II clinical study to determine if Metformin can increase Prostate Specific Antigen (PSA) doubling time for patients with Prostate Cancer who have failed primary treatment with radiation, or surgical patients that are at high risk for recurrence based on surgical pathology. Men with confirmed prostate cancer and rising serum PSA levels will receive Metformin and will be monitored for PSA response and disease progression.

Detailed description: Prostate cancer patients who have received treatment with radiation therapy or surgery, who have indicators of high-risk disease will be administered 750mg Metformin Extended Release twice per day for a period of 9 months. Metformin is an FDA-approved drug that is prescribed to treat high blood sugar levels in patients with Type 2 Diabetes. To track prostate cancer response in study participants, investigators will obtain prostate specific antigen (PSA) levels every three months for the duration of the trial.

Eligibility: Inclusion Criteria:
  -  Male > 18 years of age
  -  Biopsy confirmed adenocarcinoma of the prostate
  -  Able to swallow and retain oral medication
  -  Hemoglobin A1C <7.0%
  -  Able and willing to participate in the full 12 months of the study
  -  Able to understand instructions related to study procedures
  -  Able to read and write English
  Exclusion Criteria:
  -  Metastatic Prostate Cancer
  -  Prostate Specific Antigen Doubling Time < 6 months
  -  Prior Chemotherapy, hormonal therapy, oral glucocorticoid therapy, Gonadotropin-releasing hormone analogue therapy
  -  Current or previous use of 5α-reductase inhibitors, antiandrogen drugs, metformin, oral or injectable diabetes drug
  -  Diagnosis of Type 1 Diabetes Mellitus
  -  Known hypersensitivity to metformin
  -  any condition associated with increased risk of metformin associated lactic acidosis
  -  participation in any investigational or marketed drug trial within 30 days prior to screening or during study period
  -  any unstable, serious co-existing medical conditions including but not limited to myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias, clinically evident congestive heart failure, or cerebrovascular accident within 6 months prior to screening
  -  history of megaloblastic anemia
  -  abnormal liver function test (total bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase or serum creatinine above upper limit of normal)
  -  history of other malignancies, with the exception of adequately treated non-melanoma skin cancer, stage 1 melanoma, non-muscle invasive bladder cancer, or other solid tumors curatively treated with no evidence of disease for at least 5 years
  -  history or current evidence of substance abuse within 12 months of screening
  -  history of any illness (including psychiatric) that, in the opinion of the investigator, might confound the results of the study or post an additional risk to the subject

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

Clinical trial: Functionality of an 8-Channel Paddle Coil for Use With MRI

Summary: The objective of this study is to determine the functionality of an eight-channel paddle coil system which is to be used in future MRI studies.

Detailed description: Prostate cancer is the most common malignancy among men and the second leading cause of cancer death in men. Currently, MRI is the best imaging modality for both detecting prostate cancer and determining the presence of extra-prostatic extension. Multiparametric Magnetic Resonance, combining T2-weighted, diffusion-weighted and dynamic contrast enhanced imaging (DCE-MRI) is recommended as the minimum acceptable standard for prostate MRI examination. However, MPMRI still lacks diagnostic accuracy in the transition zone, where distinguishing cancer from proliferative nodules has proven difficult. DCE-MRI techniques evaluate the time course of signal intensities after administration of a contrast medium and have been used to successfully differentiate benign from malignant tumours, particularly in breast and prostate cancer. Unfortunately, current DCE approaches have high false-positive rates and are limited in distinguishing prostatitis and vascularized BPH nodules from cancer in active surveillance studies. Future studies that employ spectroscopic MR imaging of the prostate after administration of Hyperpolarized (13C) Pyruvate Injection, are expected to provide a robust, non-invasive method to assist in detecting and characterizing prostate cancer. The objective of this study is to determine the functionality of an eight-channel paddle coil system which is to be used in future Hyperpolarized (13C) Pyruvate Injection studies.

Eligibility: Inclusion Criteria:
  -  Healthy male volunteers between 18 and 80 years of age
  Exclusion Criteria:
  -  Any contra-indication for MR imaging (such as pacemakers, surgical implants, foreign metal objects in the body)

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

Clinical trial: Safety and Efficacy Study of Ipilimumab 3 mg/kg Versus Ipilimumab 10 mg/kg in Subjects With Metastatic Castration Resistant Prostate Cancer Who Are Chemotherapy Naive

Summary: The purpose of this study is to examine the safety and effectiveness (how well the drug works) of two different doses (3 mg/kg and 10 mg/kg) of Ipilimumab (Yervoy™) in patients with metastatic castration resistant prostate cancer.

Detailed description: Prostate Cancer Clinical Trials Working Group 2 (PCWG2)
  Response Evaluation Criteria In Solid Tumors (RECIST)

Eligibility: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
  Inclusion Criteria:
  -  Prostate cancer with metastases
  -  Prostate cancer should be castration resistant
  -  Progression during hormonal therapy
  Exclusion Criteria:
  -  Visceral metastases (eg liver, lung or brain metastases)
  -  Prior treatment with any immunotherapy for prostate cancer
  -  Prior or ongoing cytotoxic therapy for prostate cancer
  -  Autoimmune disease
  -  Inadequate hematologic, renal, or hepatic function

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

Clinical trial: Randomized, Multi-center Clinical Trial Comparing Hypofractionated Radiotherapy Boost to Conventionally Fractionated Combined With Androgen Deprivation Therapy in a High Risk Group of Prostate Cancer Patients

Summary: The main purpose of study is to compare the effectiveness of Hypofractionated IMRT boost Radiotherapy to Conventional IMRT boost Radiotherapy for high-risk prostate cancer patients combined with Androgen Deprivation Therapy.

Detailed description: Additional objectives of the study for high-risk (non-metastatic) prostate cancer patients are as follows:
  1. Analysis of number of circulating tumor cells in peripheral blood as a prognostic/predictive factors for survival.
  2. Analysis of miRNA expression levels (100, 141 and 143) in peripheral blood as a prognostic and predictive factors.
  3. Evaluation of the usefulness expression of selected proteins (PTEN, SMAD4, Cyclin D1, SPP1) as prognostic and predictive factors.
  4. Evaluation of the usefulness of the expression level of antigen-specific T cells, B-and NK cells as a prognostic factors.
  5. Evaluation of usefulness of the fiducial markers for localizing the prostate gland position during irradiation for the selected control imaging methods (2DkV, CBCT, MVCT).

Eligibility: Inclusion Criteria:
  -  men from 40 to 75 years old with confirmed prostate adenocarcinoma, prostate biopsy will be performed <180 days before the date of randomization,
  -  completed assessment of tumor differentiation according to Gleason grading allows to perform stratification; Gleason score ≤ 7 versus Gleason score> 8,
  -  general condition according to the classification of the Eastern Cooperative Oncology Group (ECOG) 0 - 1), (Appendix 1),
  -  Androgen Deprivation Therapy: prior Radiotherapy (RT) (minimum 3 months before the start of RT), concurrently with RT and after RT during follow-up (24 months) ,
  -  high risk of Prostate Cancer progression defined as presence of at least one of the following factors: cT3, Gleason> 7, PSA> 20 ng / ml or presence of at least two of cT2c, Gleason 7, PSA in the range of 10.1 ng / ml to 19.9 ng / ml, cT defined by AJCC staging 7 edition, (Appendix 2),
  -  PSA identified at least 10 days after the biopsy or before, and patients receiving fiansteryd 30 days after the cessation of therapy,
  -  no regional and distant metastases confirmed by bone scintigraphy, chest radiograph, computed tomography/magnetic resonance imaging of the pelvis,
  -  signing an informed consent to participate in a medical experiment (radiotherapy + biological material samples) (Annex 3),
  -  morphological and biochemical parameters within normal limits.
  Exclusion Criteria:
  -  the presence of active cancer except skin cancer preceding period of 5 years prior to randomization,
  -  Early surgery (radical prostatectomy) or pelvic RT,
  -  earlier hormonal therapy than is advocated in this study,
  -  co-morbidities that may significantly affect the expectancy life of the patients
  -  do not meet the criteria for inclusion.

Relevance to patient case: definitely relevant
Patient case: 70-year-old male with prostate cancer; genetic feature: PTEN

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: definitely relevant
Patient case: 70-year-old male with prostate cancer; genetic feature: PTEN

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

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

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

Clinical trial: Development and Validation of Novel MRI Methods for the Detection of Prostate Cancer Aggressiveness

Summary: The purpose of this study is to develop, validate, and evaluate the correlation of novel magnetic resonance imaging (MRI) methods with prostate cancer aggressiveness and histological data obtained during prostatectomy.

Detailed description: Prostate cancer is one of the most common neoplastic diseases in men. Prostate specific antigen (PSA) has only a limited role in the diagnosis and characterization of prostate cancer. The diagnosis of prostate cancer is still most commonly done by transrectal ultrasonography (TRUS) guided biopsy. However, TRUS guided biopsy carries a risk of increase in complications. There is an increasing interest in developing more accurate non-invasive imaging modalities which could potentially detect prostate cancer aggressiveness.
  Diffusion weighted imaging (DWI) and rotating frame relaxation measurements have shown to be particularly promising in prostate cancer detection and characterization. This study which focuses on further development and validation of DWI and rotating frame relaxation measurements will enroll 200 men with histologically diagnosed prostate cancer who will undergo magnetic resonance imaging (MRI) before prostatectomy. Anatomical MRI and novel acquisition methods focusing on DWI and rotating frame relaxation measurements will be performed using surface coils to non-invasively detect and characterize prostate cancer.

Eligibility: Inclusion Criteria:
  -  Age: 35 to 85 years
  -  Language spoken: Finnish
  -  Performance status: Karnofsky score 70 or better or WHO performance status 2 or better
  -  Diagnosis: Histologically confirmed adenocarcinoma of prostate
  -  No previous surgical, radiation or endocrine treatment for prostate carcinoma
  -  Clinical stage T1c-T3aN0 based on transrectal ultrasound, pelvic CT and bone scintigraphy
  -  Time period between the last biopsy and scheduled radical prostatectomy less than 8 months
  -  Mental status: Patients must be able to understand the meaning of the study
  -  Informed consent: The patient must sign the appropriate Ethics Committee (EC) approved informed consent documents in the presence of the designated staff
  Exclusion Criteria:
  -  previous prostate surgeries, e.g. TURP (transurethral prostatic resection)
  -  symptomatic acute prostatitis
  -  contraindications for MRI (cardiac pacemaker, intracranial clips etc)
  -  uncontrolled serious infection
  -  claustrophobia

Relevance to patient case: not relevant