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

Clinical trial: Detection of Micrometastases in Lymph Nodes of Patients With Prostate Cancer

Summary: The purpose of this study is to set up a model for detecting micrometastases in Lymph nodes of patients with prostate cancer by quantitative polymerase chain reaction and its impact on progression-free survival.


Eligibility: Inclusion Criteria:
  -  Histologically confirmed prostate cancer
  -  Locally operable tumor
  -  Negative bone scan (obligatory if Gleason Score > 7 or PSA > 20ng/ml
  -  Karnofsky ≥ 80%
  -  Age 18 - 75 years
  -  Informed consent in written form
  -  Sufficient hematologic, coagulatory and renal function
  -  Compliant patient and geographic precondition for adequate follow-up given
  Exclusion Criteria:
  -  Manifest secondary tumor
  -  Organ metastases on CT-scan /MRI or in Histology
  -  Myocardial infarction or stroke within the last 6 months
  -  Severe cardiovascular (Grade III - IV according to NYHA), pulmonary (pO2 < 60 mmHg), renal, hepatic oder hematopoetic impairment
  -  Severe active or chronic infection (z.B. pos. HIV-Antibody-Test, HBs-Ag-detected in Serum and/ or chronic Hepatitis)
  -  Severe psychiatric disease
  -  Previous chemotherapy
  -  Previous pelvine radiotherapy

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

Clinical trial: Two-Dose Level Evaluation of NX-1207 for the Treatment of Low Risk, Localized (T1c) Prostate Cancer

Summary: This study is designed to evaluate the safety and efficacy of a single injection of NX-1207 for the treatment of biopsy-confirmed low risk localized (T1c) prostate cancer in patients currently undergoing active surveillance. Study participants currently on active surveillance will be randomized either to treatment with a single intraprostatic injection of NX-1207 (2.5 mg or 15 mg) followed by active surveillance or to no treatment (continued active surveillance). Blinded efficacy evaluation will be by a second post-treatment prostate biopsy.


Eligibility: Inclusion Criteria:
  -  T1c prostate cancer
  -  Gleason score ≤ 6 with no Gleason pattern of 4 or 5.
  -  Life expectancy ≥ 5 years.
  -  Single positive prostate biopsy core with ≤ 50% cancer
  -  PSA ≤ 10 ng/mL
  Exclusion Criteria:
  -  Previous active treatment (such as surgery, brachytherapy, radiotherapy) for prostate cancer.
  -  Evidence of metastatic disease or previous positive bone scan.
  -  Previous hormonal therapy for prostate cancer.
  -  Use of certain concomitant medications, including 5 alpha reductase inhibitors (e.g. finasteride, dutasteride), androgen receptor blockers (e.g. flutamide, bicalutamide), immunosuppressants(such as Imuran™, Enbrel™, Remicade™, Humira™, etc.), anticoagulants(such as Coumadin™ or heparin), or chemotherapeutics.
  -  Previous surgical or invasive prostate treatments such as TURP, TUMT, TUNA, laser or any other minimally invasive treatment within the past 12 months.
  -  Pelvic irradiation.
  -  Urinary tract infection more than once in the past 12 months.
  -  Acute or chronic prostatitis in the past 12 months.
  -  Clinically significant renal or hepatic impairment.
  -  Bleeding disorder.
  -  Poorly controlled diabetes type 1 or type 2.
  -  Urinary retention in the previous 12 months.
  -  Self-catheterization for urinary retention.
  -  Post-void residual urine volume > 200 mL.
  -  Prior significant rectal surgery or any rectal condition with rectal stenosis or fistula.
  -  History of alcohol or substance abuse or dependence within the past 2 years.

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

Clinical trial: Predictive Value of Prostate-specific Antigen Isoform p2psa and Its Derivates in the Diagnosis of Prostate Cancer

Summary: In Europe, prostate cancer (PCa) is the most common solid neoplasm, with an incidence rate of 214 cases per 1000 men, outnumbering lung and colorectal cancer. Early detection tests have been developed in order to identify PCa while it is still confined to the prostate gland.
  The two most commonly used tests are digital rectal examination and serum prostate-specific antigen (PSA) level: however, most of cases is detected in the so called T1c stage, i.e. for PSA increasing only. As marker, PSA is organ-specific but not cancer-specific, and its levels may change as result of physical activity, sexual activity, in the presence of benign prostatic hyperplasia (BPH), acute and chronic prostatitis, as well as in the presence of PCa.
  A total serum PSA of 4.0 ng/ml has traditionally been used as threshold for considering prostate biopsy and large programs for the early detection of prostate cancer have shown that almost 70% of cancer cases can be detected using a PSA cutoff of 4.0 ng/ml. However, using a PSA threshold of 4.0 ng/ml 20% to 25% of prostate cancer cases are not detected (false-negative) and the false-positive rate is 65%. To improve the usefulness of PSA for identifying patients who require biopsy, the PSA threshold has been lowered at 2 ng/ml; moreover, the levels of free and bound PSA have been assessed, together with PSA density (the rate of PSA over the prostate volume) and PSA velocity (the rate of PSA increase), which seem to have some validity for detecting prostate cancer.
  Recent studies have shown that other new biomarkers could be used in the diagnosis of early prostate cancer as they showed a higher sensitivity and specificity. In the last two years, several investigators showed that PSA isoform [−2] proPSA (p2PSA) and its derivatives, namely, percentage of p2PSA to free PSA (%p2PSA) and the Prostate Health Index [PHI; (p2PSA / free PSA) × √tPSA)] improve the accuracy of total PSA (tPSA) and percentage of free PSA (%fPSA) in predicting the presence of PCa at prostate biopsy and they are also related to PCa aggressiveness at biopsy.
  The aim of this study is to confirm the diagnostic and prognostic predictive value of prostate-specific antigen isoform p2psa and its derivates, %p2psa and prostate health index in the detection of prostate cancer in patients with a PSA 2-10 ng/ml and/or suspicious DRE.


Eligibility: Inclusion Criteria:
  -  Men aged 18-75
  -  Total serum PSA of 2.0-10 ng/ml at entry and/or suspicious digital rectal examination
  -  Patients suitable for prostate biopsy
  Exclusion Criteria:
  -  History of PCa
  -  Previous prostate biopsy or prostatic surgery
  -  History of acute urinary retention within 3 months prior
  -  Use of any investigational or marketed 5ARI, anabolic steroids or any drug with anti-androgenic properties within 12 months prior to screening.

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

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

Clinical trial: Magnetic Resonance Imaging-Transrectal Ultrasound Fusion Image-Guided Prostate Biopsy Following Radical Prostatectomy in Patients With Prostate Cancer

Summary: This pilot clinical trial studies magnetic resonance imaging (MRI)-transrectal ultrasound (TRUS) fusion image-guided prostate biopsy following radical prostatectomy in patients with prostate cancer. Diagnostic procedures, such as MRI-TRUS fusion image-guided prostate biopsy may help find and diagnose prostate cancer

Detailed description: PRIMARY OBJECTIVES:
  I. To evaluate accuracy of the new image-guided targeted needle biopsy using the ex-vivo human prostate as obtained from fresh radical prostatectomy specimens.
  OUTLINE: Patients undergo robotic radical prostatectomy, followed by 3 MRI-TRUS fusion image-guided prostate biopsies.

Eligibility: Inclusion Criteria:
  -  Subjects must have biopsy-proven prostate cancer, or prostate-specific antigen (PSA) >= 4 ng/ml or an abnormal digital rectal examination (DRE) if consented before prostate biopsy
  -  Subjects must have at least 2, preferably 3, pre-operative magnetic resonance imaging (MRI)-identified malignant or benign lesions that measure between 10 mm and 15 mm in diameter within the prostate
  -  Subjects must have decided to have their prostate surgically removed
  Exclusion Criteria:
  -  Patients who do not give informed consent
  -  Patients with extracapsular extension of their prostate cancer

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

Clinical trial: Efficacy,Safety and Quality of Life After TOOKAD® Soluble VTP for Localized Prostate Cancer

Summary: The aim of this study is to confirm the Efficacy,the Safety and the Quality of Life after TOOKAD® Soluble VTP in localized prostate cancer patients.

Detailed description: The study is designed as a multicenter, single-arm, open label, 12 months follow-up clinical trial. Men with localized prostate cancer will be treated with TOOKAD® Soluble VTP under general anesthesia.
  Patients will be followed-up for 12 months with patient questionnaires on QoL, erectile and urinary functions, clinical evaluation with study visits at 1, 3, 6 and 12 months , Prostate Specific Antigen(PSA) testing at 3, 6 and 12 months. In addition, they will have biopsy at 6 months (± 2) and 12 months.

Eligibility: Inclusion Criteria:
  -  Histologically proven localized prostate carcinoma diagnosed using prostate biopsy showing:
  -  Gleason 3+3 prostate
  -  Gleason 3+4 prostate adenocarcinoma is acceptable provided it is not present in more than 2 cores and no more than 50% cancer in any core.
  -  Clinical stage up to cT2a - N0/Nx - M0/Mx.
  -  Serum prostate-specific antigen (PSA) ˂ 20ng/ml
  -  Prostate volume ≥ 25 cc and ≤ 70 cc.
  -  Male subjects aged 18 years or older.
  -  Signed Informed Consent Form by the patient.
  Exclusion Criteria:
  -  Unwillingness to accept the treatment.
  -  Any prior or current treatment for prostate cancer, including surgery, radiation therapy (external or brachytherapy)or chemotherapy.
  -  Any surgical intervention for benign prostatic hypertrophy.
  -  Any condition or history of illness or surgery that may pose an additional risk to men undergoing the VTP procedure.
  -  Life expectancy less than 10 years.
  -  Participation in another clinical study involving an investigational product within 1 month before study entry.
  -  Subject unable to understand the patient's informed consent document, to give consent voluntarily or to complete the study tasks, especially unable to understand and fulfill the health-related QoL questionnaire.
  -  Subject in custody and or in residence in a nursing home or rehabilitation facility.
  -  Any condition or history of active rectal inflammatory bowel disease or other factors which may increase the risk of fistula formation;
  -  Any hormonal manipulation (excluding 5-alpha-reductase inhibitors) that alters androgen production or use of androgen supplements within the previous 6 months;
  -  Any history of urethral stricture disease;
  -  Any history of acute urinary retention within 6 months of study entry

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

Clinical trial: Development of Clinical Assessment Technique Using Multi-radiotracer PET/MR in Prostate Cancer

Summary: To development of clinical assessment technique using multi-radiotracer positron emission tomography/magnetic resonance (PET/MR) in prostate cancer
  -  to establish the optimal imaging technique of PET/MR using multiple radioactive tracers for prostate cancer
  -  to establish the imaging biomarker using PET/MR for clinical assessment of prostate cancer and early detection of recurrent prostate cancer

Detailed description: To establish the optimal imaging technique of PET/MR using multiple radioactive tracers for prostate cancer
  -  Recruiting 30 patients with prostate cancer ahead to radical prostatectomy
  -  PET/MR using 18F-choline with dedicated prostate MRI in all patients
  -  PET/MR using 18fluoride(F)-fluorodeoxyglucose(FDG)in all patients after 2-7 days
  -  PET/CT using 18F-FDG in all patient immediate after 18F-FDG PET/MR
  -  outcome assessment: comparison of scan time, image quality, tumor detection rate, standardized uptake values of lesions
  -  establishing optimal imaging technique for prostate PET/MR
  To establish the imaging biomarker using PET/MR for clinical assessment of prostate cancer
  -  comparison of findings on PET/MR, MRI and PET/CT with pathological mapping after radical prostatectomy
  -  outcome assessment: accuracy of PET/MR for localization and staging of prostate cancer compared with MRI only and PET/CT only
  To establish the imaging biomarker using PET/MR for early detection of recurrent prostate cancer
  -  Recruiting 15 patients with recurrent prostate cancer treated by surgery, hormone, or radiation therapy
  -  Recruiting 15 patients with treated prostate cancer without recurrence
  -  PET/MR using 18F-choline with dedicated prostate MRI in all patients
  -  PET/MR using 18F-FDG in all patients after 2-7 days
  -  PET/CT using 18F-FDG in all patient immediate after 18F-FDG PET/MR
  -  comparison of findings on PET/MR, MRI, and PET/CT with clinical data in two patient groups with or without recurrent prostate cancer
  -  outcome assessment: accuracy of PET/MR for early detection and localization of recurrent prostate cancer compared with MRI only and PET/CT only

Eligibility: Inclusion Criteria:
  -  patient with prostate cancer before treatment
  -  patient with prostate cancer treated
  -  patient with prostate cancer recurrent
  Exclusion Criteria:
  -  patient with contraindication for MRI
  -  Patient with severe renal impairment

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

Clinical trial: Circulating Tumor Cell Analysis in Patients With Localized Prostate Cancer Undergoing Prostatectomy

Summary: This study will evaluate a method to detect tumor cells that are circulating in the blood without getting a biopsy. The investigators already know from other studies that cancer tumors shed a small number of cells into the bloodstream every day. These are called circulating tumor cells (CTCs). Some early studies indicate the amount and type of CTCs in the blood can help determine the status of the tumor itself and the way it is responding to treatment. In this study, the investigators will compare the number of CTCs in the blood at different time frames before and after surgery to remove the prostate.

Detailed description: The investigators will collect a blood sample for the study when the participant has other blood tests drawn for their cancer treatment. The investigators will take one sample to check prostate specific antigen (PSA) levels and another blood sample for CTC analysis. The investigators will be drawing blood at the following time points: Screening; One day after surgery; 7-14 days after surgery; 3-6 months after surgery; at PSA recurrence or at two years.

Eligibility: Inclusion Criteria:
  -  Male
  -  18 years of age or older
  -  Pathologically confirmed diagnosis of prostate adenocarcinoma
  -  Non-metastatic prostate cancer
  -  Planned radical prostatectomy at Massachusetts General Hospital
  Exclusion Criteria:
  -  Patients must not have received prior radiation therapy, hormone therapy, or other medical therapy for prostate cancer prior to prostatectomy. Post-prostatectomy therapy at the discretion of the patient's treating physician(s) is allowed.
  -  Patients must not have metastatic prostate cancer
  -  No prior or current diagnosis of epithelial malignancy, except for skin cancer (squamous cell carcinoma or basal cell carcinoma)

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

Clinical trial: French Digestive Polyposis Cohorte Family Adenomatous Polyposis With APC and MYH Gene Mutations , Cowden's Disease With PTEN Gene Mutation, Peutz Jeghers Disease With STK 11 Gene Mutation ,juvénil Polyposis With SMAD 4 Gene Mutation , Serrated and Hyperplastic Polyposis

Summary: French cohorte about polyposis digestive diseases

Detailed description: Family Adenomatous Polyposis APC and MYH Genes Peutz Jeghers Disease Cowden Disease Festooned polyposis Juvenile polyposis Hyperplastic polyposis

Eligibility: Inclusion Criteria:
  -  APC Gene mutation
  -  MYH Homozygote mutation
  -  COWDEN Disease with PTEN gene mutation
  -  Peutz Jeghers Disease with STK 11 gene mutation
  -  Juvenile polyposis with SMAD 4 gene mutation
  Exclusion Criteria:
  -  heterozygote MYH Gene Mutation

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

Clinical trial: Prostate Cancer Screening Among Men With High Risk Genetic Predisposition

Summary: This will be a prospective diagnostic trial of screening for prostate cancer among men with genetic predisposition.

Detailed description: This will be a prospective diagnostic trial of screening for prostate cancer among men with genetic predisposition. The target population is males (40-70 year old) carrying a BRCA1 and/or BRCA2 germ line mutation. They will be identified via our Genetic counseling unit. All men after signing an informed consent will undergo the following tests: PSA, free to total PSA, MRI of prostate and prostate biopsy. The primary endpoint will be to estimate the prevalence, stage and grade of prostate cancer in this population. Additionally, the study aims to estimate the impact of these germ line mutations on benign prostatic hyperplasia. Furthermore, this study aims to create a bio-bank of tissue, urine and serum of this unique cohort for future investigations. Finally, this study will identify an inception cohort for future interventional studies of primary and secondary prevention.

Eligibility: Inclusion Criteria:
  -  Male carrier of mutation in BRCA 1\2 or germ-line mutations in the MMR genes (MLH1, MSH2 , MSH6 or PMS2).
  -  WHO performance status 0-2 (Appendix 2)
  -  Absence of any psychological, familial, sociological or geographical situation potentially hampering compliance with the study protocol and follow-up schedule.
  -  Individuals that cannot undergo the MRI exam due to high creatinine level or claustrophobic will be disc loud from the MRI part.
  -  Informed written consent must be sought according to ICH/EU GCP, before subject registration.
  Exclusion Criteria:
  -  Previous cancer with a terminal prognosis of less than five years.
  -  Previous prostate cancer

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

Clinical trial: Prostate Hypoxia - TIC

Summary: Prostate cancer is the most commonly diagnosed form of cancer in Canadian men. In 2006, greater than 250,000 men were diagnosed with prostate cancer in the United States and Canada with more than 32,000 men dying of their disease. Using the prognostic variables of T-category, the serum prostate specific antigen (PSA), and the pathologic Gleason score (GS), men with localized prostate cancer are placed in low, intermediate and high-risk groupings. Usually this is treated with surgery, radiation therapy, hormone therapy and/or watchful waiting (also known as active surveillance). While these treatments are quite effective, tumours are likely to recur in about 40% of cases. There is a need for additional prostate cancer treatments. To address this need, many experimental therapies are being developed and tested in mice with prostate tumors. This includes the study of aggressive prostate cancer cells such as stem cells, or Tumour Initiating Cells (TICs), or oxygen deprived cells, which may be the ones most likely to re-grow into a tumour or spread throughout the body. Researchers want to try and isolate these special cells from the prostate after surgery to study their features, and to see if they can re-grow as solid tumours in mice. Researchers would like to test whether the prostate cancer stem cells are more resistant or less resistant to treatments. This will allow researchers to study and test new treatments that specifically target resistant and aggressive prostate cancer cells. The investigators hypothesize that marker-defined TIC cells or hypoxic cancer cells have unique genetics in primary prostate cancers and are relatively chemo- and radio-resistant.


Eligibility: Inclusion Criteria:
  -  Prostate cancer patients with bulky intermediate risk or high-risk disease who have already agreed to undergo an open radical prostatectomy at Princess Margaret Cancer Centre-UHN:
  -  Clinical stage T2-T3 N0 M0
  -  Pathology of adenocarcinoma of the prostate AND
  -  Gleason score 7 with >/= 50 % biopsies involved with tumour; OR
  -  Gleason score 8 or above (any percentage of biopsies)
  Exclusion Criteria:
  -  Patients with clinical T4, N1 or M1 disease
  -  Patients with histologies other than adenocarcinoma
  -  Patients unable to ingest pimonidazole tablets

Relevance to patient case: not relevant