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

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

Clinical trial: Study to Evaluate the Safety and Efficacy of Sirolimus, in Subject With Refractory Solid Tumors

Summary: This study is a single arm, pilot study of sirolimus in patient with Phosphatidylinositide-3-kinase (PIK3CA) mutation, PIK3CA amplification , PIK3CA-AKT pathway aberration Refractory solid tumor and/or specific sensitivity to mTOR inhibitors by Avatar scan that has progressed following standard therapy or that has not responded to standard therapy or for which there is no standard therapy.
  sirolimus 1mg will be administered orally daily. To investigate the efficacy and safety of sirolimus in patient with Refractory solid tumor.


Eligibility: Inclusion Criteria:
  -  Provision of fully informed consent prior to study specific procedures.
  -  Patients must be >= 19 years of age
  -  Phosphatidylinositide-3-kinase (PIK3CA) mutation, PIK3CA amplification , PIK3CA-AKT pathway aberration( H1047R, E542K, E545K, PTEN LOSS) Refractory solid tumor and/or specific sensitivity to mTOR inhibitors by Avatar scan that has progressed following standard therapy or that has not responded to standard therapy or for which there is no standard therapy.
  -  ECOG Performance status0-2
  -  Have measurable or evaluated disease based on RECIST 1.1 as determined by investigator.
  -  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 subject with liver metastases) Creatinine<= 1.5 X UNL
  -  Patients of child-bearing potential should be using adequate contraceptive measures should not be breast feeding and must have a negative pregnancy test prior to start of dosing
  -  Adequate heart function
  Exclusion Criteria:
  -  Patients with second primary cancer, except:adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumor curatively treated with no evidence of disease for <= 5 years.
  -  Has known active central nervous system(CNS) metastases
  -  Has an active infection requiring systemic therapy
  -  Pregnancy or breast feeding
  -  Patients with cardiac problem
  -  Any previous treatment with sirolimus

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

Clinical trial: Circulating Tumor DNA Detection in Surveillance of Surgical Lung Cancer Patients

Summary: Conduct a prospective study to confirm blood and urine ctDNA detection value in non-small-cell lung cancer patients.

Detailed description: Studies have shown the feasibility of detecting mutation status by blood and urine circulating tumor DNA (ctDNA)in non-small cell lung cancer (NSCLC) patients. However, no prospective has been conducted for usage of ctDNA in postoperative surveillance of NSCLC patients.
  We plan to compare tumor makers and radiographic approaches with blood and urine ctDNA in surveillance to assess the lead time of postoperative tumor relapse in stage ⅢA NSCLC patients. And evaluate the correlation between ctDNA level with tumor relapse or metastasis.

Eligibility: Inclusion Criteria:
  -  Aged 18 to 80 years
  -  Undergo radical surgery（R0 resection）
  -  Histologically confirmed diagnosis of stage ⅢA non-small cell lung cancer
  -  Positive Driver mutation(EGFR、PTEN、PIK3CA、BRAF、K-RAS、Her2) in tumor tissue
  -  Blood or urine circulating tumor detect the driver mutation detected in tumor tissue
  -  Patients must have given written informed consent
  Exclusion Criteria:
  -  Unable to comply with the study procedure
  -  Malignant tumor history within the past 5 years
  -  Patients who received any treatment prior to resection
  -  R1 or R2 resection
  -  Coexisting small cell lung cancer
  -  Received target drug therapy after surgery
  -  Unqualified blood or urine samples

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

Clinical trial: Expression of Tumor Markers in Circulating Tumor Cells of Metastatic Hormone-sensitive Prostate Cancer

Summary: As prostate cancer progresses, tumor cells dissociate and enter the bloodstream. Considered a "liquid biopsy," these circulating tumor cells (CTC) can show how a patient's cancer evolves and responds to treatments. The purpose of this study is to determine whether sequentially analyzing the expression of tumor markers in circulating tumor cells in newly diagnosed metastatic hormone-sensitive prostate cancer patients can predict the outcome of these patients.


Eligibility: Inclusion Criteria:
  1. Male patients;
  2. 18 yrs and older, and 80 yrs and younger;
  3. Histologically or cytologically proven prostate adenocarcinoma;
  4. Imaging examinations including Emission Computed Tomography (ECT),Positron Emission Tomography (PET),Computed Tomography(CT)and Magnetic Resonance Imaging (MRI) revealed non-regional lymph node metastasis, bone metastasis, or visceral metastasis;
  5. Not yet receiving hormonal therapy;
  6. Not yet receiving chemotherapy previously;
  7. Not yet receiving radical prostatectomy, radiotherapy, or transurethral resection of the prostate (TURP) previously;
  8. Patients are willing to participate and can be followed up regularly；
  Exclusion Criteria:
  1. Received radical prostatectomy, radiotherapy, or transurethral resection of the prostate (TURP) previously;
  2. Received androgen deprivation therapy (including surgical castration, medical castration, anti-androgen therapy, and maximum androgen blockade) before inclusion;
  3. Patients received chemotherapy previously;
  4. Combined with other malignant tumor history (in addition to the skin basal cell carcinoma or other tumors that have been cured more than five years);

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

Clinical trial: Studies of the Tumour Suppressor Gene PTEN - Endometrial Cancer

Summary: This project seeks to understand the role of the PTEN tumour suppressor gene in endometrial cancer (tumours of the uterine lining), the most common gynecologic cancer in the developed world. The studies in this program span the spectrum from fruit flies to humans, as part of a synergistic partnership that will significantly enhance our understanding of the molecular genetic events involved in the development and progression of endometrial cancer. The discovery of new targets for therapy, and the ability to evaluate these in subsequent clinical trials is a significant strength of this scientific interaction, which may result in cures for patients with primary and relapse endometrial cancer and prevention of this cancer in women who are at high risk.

Detailed description: PTEN is a critical module that regulates effects of sex hormones on the growth and apoptosis of endometrial cells; and plays an important role in the pathogenesis of subgroups of endometrial cancers, their biologic behaviour and responses to therapeutic agents. Furthermore, mutational inactivation of the PTEN gene can serve as an independent molecular marker that can predict relapse and survival in endometrial cancer. The prognostic effects of PTEN may also be modulated by other tumour suppressor gene losses including P53 mutations, by hormone receptor status, and microsatellite instability.

Eligibility: Inclusion Criteria:
  -  Age 18 and older
  -  patients who had a hysterectomy
  -  patient able to provide consent and complete questionnaire

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

Clinical trial: Difference in Pain Perception by Patients With Prostate Biopsy Using Instillagel Compared With Guided Ultrasound Gel

Summary: This is a randomized controlled trial. One group (intervention group) will get in advance to the prostate biopsy rectal approximately 5 cc Instillagel. And one group (control group) will get in advance to the ultrasound -guided prostate biopsy rectal gel. Pain is measured using the Numerical Rating Scale (NRS). The NRS is an imaginary line from 0 until 10. The 0 is no pain and 10 is most worst imaginable pain.

Detailed description: Urologist within Rijnstate use both Instillagel and ultrasound gel during prostate biopsy. According to the protocol, the ultrasound-guided prostate biopsy must be performed using ultrasound gel. Some urologists departed from the protocols because they think that Instillagel will give a pain reduction. With this research we investigate whether Instillagel will have an effect on the pain perception bij the patients.
  There will be three moments of pain measurements; Prior to het prostate biopsy. Immediately after the prostate biopsy. And five to thirty minutes after the prostate biopsy, when the patient is dressed and before the patient goes home.
  Primary endpoint Pain measured by the Numeric Rating Scale
  Secondary endpoints
  -  Age of patient
  -  Previous prostate biopsy
  -  The number of biopsies taken
  -  Presence of prostate cancer
  -  Other complications as after prostate biopsy
  The prostate biopsy will be performed by a urologist working at the outpatient clinic of Rijnstate. The ultrasound equipment that will be used during prostate biopsy is Aloka ProSound SSD-3500 or Aloka ProSound SSD or SV-3500 SX.

Eligibility: Inclusion Criteria:
  -  outpatient ultrasound guide prostate biopsy
  -  > 40 years old.
  -  Good knowledge of dutch language
  Exclusion Criteria:
  -  coagulation disorders
  -  disorders of the rectum like hemorrhoids, anal fistula, proctitis, rectal polyps and rectal cancer.
  -  treated for active urinary tract infection
  -  known of allergy to lidocaine
  -  taking antidepressants
  -  using anaesthetic agents
  -  neurological disorders such as Parkinsons disease, hernias and spinal cord injury
  -  treated with radiotherapy for prostate cancer

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

Clinical trial: Sulphate Accumulation in Prostate

Summary: This study evaluates whether a broccoli intervention (≥ 4 weeks) will result in differences in tissue sulphate levels in men scheduled for prostate biopsies. Comparisons will be made between participants randomised to the broccoli-rich diet and those randomised to the non-intervention arm.

Detailed description: Epidemiological studies provide evidence for a negative correlation between prostate cancer and intake of cruciferous vegetables such as broccoli. Preliminary data from ongoing intervention trials carried out at the IFR suggest that dietary changes can directly influence the metabolic profile of prostate tissue. The most significant result observed to date is that of sulphate accumulation within the prostate. The additional sulphate is likely to drive synthesis of 3'-phosphoadenosine-5'-phosphosulfate, a universal sulphate donor, a process which would consume energy from ATP. A significant rise in levels of both ADP and phosphate has also been observed in prostate tissue from these studies, supporting the potential depletion of cellular ATP. Interestingly, the data indicate that the extent of ADP accumulation is negatively correlated with prostate cancer progression.
  The investigators now propose to undertake a two arm parallel un-blinded study to test the hypothesis that a short-term intervention with broccoli soups will lead to the accumulation of sulphate and ADP in prostate tissue. A potential increase in glutathione metabolites indicating a change in redox status, and therefore functional status, of specific genes involved in tumour suppression (PTEN) will also be investigated.
  Furthermore, the investigators aim to determine whether the accumulation of sulphate and ADP is specific to the prostate gland through the metabolic analyses of both prostate and non-prostate tissues.

Eligibility: Inclusion Criteria:
  -  Males
  -  Scheduled for TPB as part of routine investigation or staging for prostate cancer
  -  Aged 18-80 years
  -  BMI between 19.5 and 35 kg/m2
  -  Smokers and non-smokers
  Exclusion Criteria:
  -  Those regularly taking 5α-reductase inhibitors or testosterone replacement medicines
  -  Those on warfarin treatment
  -  Those diagnosed with diabetes
  -  Those diagnosed with or suspected to be high-risk for human immunodeficiency virus (HIV) and/or hepatitis
  -  Those allergic to any of the ingredients of the broccoli soups
  -  Those taking dietary supplements or herbal remedies which may affect the study outcome. Please note that some supplements may not affect the study and this will be assessed on an individual basis
  -  Those that are unable to understand English or give informed consent
  -  Parallel participation in another research project that involves dietary intervention
  -  Any person related to or living with any member of the study team

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

Clinical trial: Evaluation of the Potential Association Between 5α-reductase Inhibitors Prescription and Occurrence of High Grade Prostate Cancers

Summary: This is a multicenter, cohort study based on medico-administrative data from pathology laboratory registries and drug reimbursement files (CNAM-TS).

Detailed description: Identification process will be retrospective and prospective using medico-administrative data from all pathology laboratory registries in Brittany and drug reimbursement files for patients living in Brittany, France.
  An extraction from drug reimbursement files of French health reimbursement agency (CNAM-TS) for patients living in Brittany, France will be performed on the following request: reimbursement of any pharmacologic treatment patented for symptomatic benign hyperplasia between January 1st 2010 and December 31st 2011, and no diagnosis of prostate cancer before December 31st, 2011. This extraction has to be done in 2013 to catch data as far as 2010 and will encompass health reimbursement for prostate examination. A second extraction will be done in 2014 to complete data from the end of 2013.
  Secondly, identification of patients will use pathology laboratory registries, based on code for prostate examination (prostate biopsy, prostatectomy or prostate resection); involvement of all pathology laboratories in Brittany ensures completeness of collection of prostate examination results for the study period (January 1st, 2012 to December 31st, 2013). A list of patients will be recorded at each pathology laboratory level with date of birth, date of prostate examination, type of exam, results with Gleason score along with a study number on electronic file.
  By January 2014, link to reimbursement file (that is data on all reimbursement within 3 years: 2009 to 2011 previously extracted from the French health reimbursement agency) will be done thanks to three key variables (date of birth, date of prostate examination, identification of pathology laboratory) and all data from all centers will set up into one global file.
  This design will allow evaluation of association between 5-ARI and either high grade prostate cancer or low grade prostate as opposite association could be observed. In addition this design focuses on the target population, i.e. patients with symptomatic benign prostate hyperplasia, identified through reimbursement of drugs patented for symptomatic benign prostate hyperplasia.

Eligibility: Inclusion Criteria:
  -  Men with a reimbursement of any pharmacologic treatment patented for symptomatic benign prostate hyperplasia between January 1st 2010 and December 31st 2011, affiliated to French health system and living in Brittany, France.
  Exclusion Criteria:
  -  Prostate cancer with a date of diagnosis before December 31st, 2011, patients enrolled in surveillance program with scheduled prostate biopsy, patients not affiliated to French health system.

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

Clinical trial: PROSENZA: Prospective Multi-centre Study of Prognostic Factors in CRPC Treated With Enzalutamide

Summary: Prospective Multi-centre Study of Prognostic Factors in Castration Resistant PROState Cancer Treated With Enzalutamide (PROSENZA).

Detailed description: Observational study to analyze prognostic factors in castration resistant prostate cancer patients.

Eligibility: Inclusion Criteria:
  1. Provision of informed consent.
  2. Eighteen years of age or older.
  3. General health status acceptable and compatible with active treatment: ECOG ≤0-2.
  4. Histological confirmation of prostate cancer diagnosis.
  5. Prior resistance to biochemical castration with an LHRH agonist (or surgical castration through bilateral orchiectomy) and progression to an anti-androgen drug (e.g. bicalutamide, nilutamide or cyproterone acetate).
  6. Biochemical progression upon prior treatment in agreement with PSAWG2 criteria, confirmed by a second PSA test.
  7. Castrate levels of testosterone in peripheral blood: testosterone <0.5 ng/ml.
  8. Candidates for standard treatment with enzalutamide: 160 mg continue on cycles of 28 days.
  9. Availability of anatomopathological tumour material (e.g. a paraffin block of the prostatectomy or initial biopsy of the metastasis).
  10. Acceptable hematological, hepatic and renal functions and without contraindications for the administration of abiraterone in agreement with its respective summary of products characteristics.
  Exclusion Criteria:
  1. Previous cancer diagnosis, except those patients who had a localized malignant tumour and who are five years cancer-free, as well as subjects with a history of skin cancers (of non-melanoma type) or excised in situ carcinomas.
  2. Medical histories, be they psychiatric or of any other character, which, according to the judgement of the investigator, might interfere with the subject's granting of informed consent or the safe execution of the procedures required in the study.

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

Clinical trial: Optimizing the Effectiveness of Routine Post-treatment Surveillance in Prostate Cancer Survivors

Summary: Through this study, the investigators seek to identify the benefits (improved survival) and harms (more procedures, more treatment, side effects, and quality-of-life impact) from different surveillance frequencies—every three vs. six vs. 12 months. Using the National Cancer Database and quality-of-life data from a large group of prostate cancer survivors, the investigators aim to compare survival, procedures/tests, treatments, and side effects in prostate cancer survivors who are followed with alternative surveillance frequencies and compare quality-of-life outcomes. The overall goal of the study is to provide high-quality data that will allow development of a personalized, risk-based tailored approach to post-treatment surveillance for prostate cancer.


Eligibility: Inclusion Criteria:
  -  Patient data part of the NCDB
  -  Diagnosed with prostate cancer in 2004-2005.
  -  Treated for prostate cancer with surgery (prostatectomy) or radiation therapy
  Exclusion Criteria:

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

Clinical trial: uPAR PET/CT in Radium-223-dichloride Treatment of Patients With Metastatic Castration-resistant Prostate Cancer

Summary: The purpose of this study is to investigate the applicability of urokinase plasminogen activator receptor (uPAR) Positron Emission Tomography (PET) / CT molecular imaging in patients with metastatic castration-resistant prostate cancer (mCRPC)

Detailed description: 68Ga-NOTA-AE105 is a radioligand targeting urokinase plasminogen activator receptor (uPAR), which is a promising imaging biomarker of tumor aggressiveness. 68Ga-NOTA-AE105 PET/CT will be applied in patients with mCRPC during treatment with Radium-223. PET/CT will be performed before initiation of Radium therapy and after two treatment cycles. The initial semiquantitative uptake (standard uptake values, SUVs) of 68Ga-NOTA-AE105 in metastases as well as the change in these parameters after therapy will be correlated with overall survival and progression free survival.

Eligibility: Inclusion Criteria:
  -  Metastatic castration resistant prostate cancer
  -  Approved to receive Radium-223 therapy
  -  Written and oral consent
  Exclusion Criteria:
  -  Lack of communication skills
  -  Other known malignant disease
  -  Known allergy towards IMP
  -  Severe claustrophobia
  -  If a participant exhibits allergic reaction i the IMP, the participant will be excluded from further participation in the study

Relevance to patient case: not relevant