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: Vitamin D and Prostate Cancer: A Clinical Study Enrolling Subjects Undergoing Prostatectomy

Summary: The study population will be 80 adult men who have been diagnosed with prostate cancer who are scheduled to have their prostate surgically removed at either the Medical University of South Carolina (MUSC) or the Ralph H. Johnson VAMC, both located in Charleston, SC. The men will be randomized into two groups: one group will take vitamin D3 supplementation and the other will take a placebo. Blood levels of vitamin D3 will be obtained at the beginning of the study and again after two months, just prior to the surgical procedure (prostatectomy). Prostate tissue will be obtained from the surgical procedure and studied for the effect of vitamin D on the prostate cancer cells.

Detailed description: This study will enroll 80 (40 per study arm) subjects (>18 years of age), recently diagnosed with prostate cancer (histologically documented adenocarcinoma of the prostate), who are scheduled to undergo prostatectomy.
  Eligible subjects will be recruited in the Urology Clinic at MUSC or Ralph H. Johnson VAMC. All subjects will be refered to the study by their Urologist. At the baseline visit, consent will be obtained before any study procedures are initiated. A blood sample will be obtained for 25(OH)D3 analysis. Subjects will be randomized to either the intervention group (vitamin D3 4000 IU daily) or the placebo group and take the study medication for approximately two months before their scheduled prostatectomy. The final study visit is the day of surgery. A blood sample for 25(OH)D3 analysis will be obtained. Prostate tissue will be collected from the Pathologist for (a) genomics (RNA sequencing) analysis; (b) proteomics (proteins, glycons and lipids) analysis and (c) Vitamin D Receptor (VDR) by immunohistochemistry.

Eligibility: Inclusion Criteria:
  -  Diagnosis of prostate cancer (by prostate biopsy)
  -  Scheduled to undergo a prostatectomy
  -  Ability to give his own consent to participate in the study
  Exclusion Criteria:
  -  Serum 25(OH)D level less than 8ng/ml or greater than 50 ng/ml
  -  Vitamin D3 supplementation greater than or equal to 1000 IU daily

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: Assessment of the Mutation of Pig-A Gene as Biomarker of Genotoxic Exposure in Humans

Summary: The evaluation of the impact of environment on the incidence of cancer is a major public health issue. Increased knowledge in this area is necessary for the implementation of primary prevention means with appropriate preventive measures but also to the implementation of secondary prevention measures with targeted screening actions.
  Among the environmental exposures that may lead to cancer, mutagenic environments are of major importance, and the causal link between environmental genotoxicity and cancer has been established for a long time. It is also well established that susceptibility to mutation is highly variable among individuals. This is explained by genetic polymorphisms of genes involved in metabolism and in genome stability.
  The identification of biomarkers of exposure to mutagenic environments is necessary for assessing the impact of an environment in humans. Some studies in animals have shown that the PIG-A gene may be a biomarker of exposure to a mutagenic environment. In particular, a significant increase in erythrocyte PIG-A mutants has been demonstrated in rats after a genotoxic exposure to cisplatin, but it has so far not been evaluated in humans. One study of healthy volunteers shows that the frequency of PIG-A mutated cells in humans can be estimated efficiently and reliably.
  The PIG-A gene meets all the necessary criteria for a sentinel gene for tracking of spontaneous somatic mutation frequency or induced a mutagenic environment: ubiquitous expression, phenotypic change linked to a mono-allelic mutation viability of mutated cells , spectrum off inactivating mutations (deletions, substitutions, chromosomal rearrangements). Finally, the detection of the disappearance of glycosylphosphatidylinositol on the plasma membrane is easily achievable by flow cytometry.


Eligibility: Inclusion Criteria:
  -  Major patients,
  -  The patients achieving a breast cancer
  -  Patients who have benefited from a breast surgery
  -  Patients to have an external adjuvant radiotherapy.
  -  Patients being able to read and understand French.
  -  Patients beneficiaries of a social security scheme.
  -  Pregnant women can not participate in this study. A pregnancy test should only be prescribed when clinically indicated, regardless of the course of the study.
  -  Patients who received information and signed informed consent
  Exclusion Criteria:
  Patients who received chemotherapy before radiation therapy.
  -  Minor patients
  -  Patients who do not speak French and / or unable to read and understand French.
  -  Patients who have had radiotherapy history
  -  Patients who have had a history of chemotherapy
  -  Patients who have not received the information and had not signed informed consent for participation

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: Incidence of Second Primary Malignancies in Castration-Resistant Prostate Cancer: An Observational Retrospective Cohort Study in the US

Summary: This study is conducted to estimate population-based incidence rates of second primary malignancies among patients with CRPC similar to those treated with Xofigo. These rates will provide context for second primary malignancy incidence rates from the REASSURE study.
  Furthermore this study aims to provide further information about the documentation of bone metastases in Medicare data and the extent of use of only oral androgen deprivation drugs among patients with Medicare Part D coverage, as well as to estimate overall survival of the study population.

Detailed description: Xofigo (radium-223 dichloride) is an alpha-emitting pharmaceutical, which was approved for the treatment of patients with castration-resistant prostate cancer (CRPC), symptomatic bone metastases, and no known visceral metastatic disease. The long-term safety profile of Xofigo is evaluated in the prospective REASSURE study, which estimates the incidence rates of second primary malignancies in patients with CRPC receiving Xofigo.
  To provide context on that, this retrospective study is conducted to estimate background rates of second primary malignancies among patients with CRPC similar to those who are treated with Xofigo.

Eligibility: Inclusion Criteria:
  -  Enrolled in both Medicare Parts A and B for at least 1 year before the cohort entry date (minimum lookback period for comorbidities and treatments)
  -  Primary site code of prostate cancer (International Classification of Diseases for Oncology, Third Edition [ICD-O-3] topography code C61.9) in SEER data
  -  Surgical castration or androgen deprivation therapy after prostate cancer diagnosis; androgen deprivation therapy will be indicated by the use of any of the following drugs: abarelix, bicalutamide, buserelin, cyproterone, degarelix, diethylstilbestrol, estramustine, flutamide, gonadorelin, goserelin, histrelin, leuprolide, medroxyprogesterone, megestrol, nafarelin, nilutamide, polyestradiol, triptorelin
  -  Evidence that prostate cancer was resistant to surgical castration or androgen deprivation therapy ("castration-resistant prostate cancer"), as indicated by starting one of the following second-line systemic therapies (cohort entry date): abiraterone, cabazitaxel, docetaxel, enzalutamide, mitoxantrone, or sipuleucel-T
  -  Cohort entry date 01 January 2006 or later
  -  Age 65 years or older in the US on the cohort entry date
  Exclusion Criteria:
  -  Enrollment in an HMO (Health Maintenance Organization) in the year before the cohort entry date
  -  Diagnosis of any cancer other than prostate cancer or nonmelanoma skin cancer on or before the cohort entry date
  -  Any diagnostic code for metastases other than bone metastases or lymph node metastases on or before the cohort entry date
  -  Any claim for treatment with Xofigo on or before the cohort entry date.

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

Clinical trial: A Study to Investigate the Impact of Abiraterone Acetate and Enzalutamide on Health-related Quality of Life, Participant-Reported Outcomes, and Medical Resource Use in Metastatic Castration-resistant Prostate Cancer Participants

Summary: The purpose of this observational study of metastatic castration-resistant prostate cancer (mCRPC) participants is to explore whether or not there are differences between participants treated with abiraterone acetate and enzalutamide on the health-related quality of life (HRQoL), Fatigue, Pain, Cognitive function and medical resource use (MRU).


Eligibility: Inclusion Criteria:
  -  Male 18 years of age or older
  -  Participant with histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate
  -  Participant with documented metastatic prostate cancer
  -  Participant with documented castration resistance with progression of prostate cancer on androgen deprivation therapy (ADT)
  -  Participant who will be initiated on either abiraterone acetate or enzalutamide for the treatment of metastatic castration-resistant prostate cancer (mCRPC) that is asymptomatic or mildly symptomatic (per physician's evaluation) after failure of ADT at the time of treatment initiation
  -  Participants who signed a participation agreement or Informed consent form (ICF) per local regulations
  -  The treatment decision (abiraterone acetate or enzalutamide) by the treating physician must have been taken before enrollment into the study
  -  Baseline patient-reported outcomes (PROs) must be captured before the first administration of abiraterone acetate or enzalutamide.
  Exclusion Criteria:
  -  Patient who has received any chemotherapy/cytotoxic agent to treat their mCRPC before abiraterone acetate or enzalutamide initiation; or ; treat their metastatic hormone-sensitive prostate cancer (mHSPC) <12 months prior to abiraterone acetate or enzalutamide initiation.
  -  Participant who is not capable of completing a patient survey
  -  Participant who has received or is currently receiving abiraterone acetate or enzalutamide
  -  Patient receiving an investigational treatment for prostate cancer of any kind before or at the time of initiation of abiraterone acetate or enzalutamide
  -  Participant who is currently included in other observational studies with abiraterone acetate sponsored by Janssen

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: Sirolimus and Cyclophosphamide in Metastatic or Unresectable Myxoid Liposarcoma and Chondrosarcoma

Summary: Chondrosarcoma and liposarcoma consists of different subtypes with a wide range of patient survival. Current treatment options consist of wide surgical resection, however for patients with a local recurrence or metastatic disease the outcome is poor. New treatment options being evaluated and mouse models show in vivo that mammilian target of rapamycin (mTOR) inhibition can prevent tumour growth. mTOR is an kinase that is present in two complexes and thereby activates multiple pathways. Aberrant mTOR signalling is known to be involved in cancer cell survival. Several clinical studies for patients with bone or soft tissue sarcoma treated with mTOR inhibitors have been conducted and they show promising results. From these studies the investigators can conclude that the combination of an mTOR inhibitor with cyclophosphamide shows promising results in chondrosarcoma. With the lack of other treatment options for unresectable and metastatic chondrosarcoma or myxoid liposarcoma the Eurosarc consortium (www.eurosarc.eu) decided to treat these patients in a standardised way according to a common protocol with the combination of sirolimus and cyclophosphamide using the growth modulation index for evaluation in the current clinical study protocol.


Eligibility: Inclusion Criteria:
  -  Pathologically proven conventional chondrosarcoma
  -  Or pathologically proven myxoid liposarcoma with PIK3CA mutation or Phosphatase and tensin homolog (PTEN) loss
  -  Or pathologically proven mesenchymal or dedifferentiated chondrosarcoma
  -  Patient is 18 years and up
  -  Documented radiographic progression of disease according to RECIST 1.1 criteria in last 6 months
  -  Written signed informed consent
  -  Adequate bone marrow function (Hb ≥ 6.0 mmol/L, absolute neutrophil count ≥ 1.5 x 109/L, platelets ≥ 80 x 109/L)
  -  Availability of archival tumor material for central review or be able to perform a 3 core fresh biopsy
  -  Ability to adhere to the study visits and all protocol requirements
  Exclusion Criteria:
  -  Previously treated with an mTOR inhibitor
  -  Known to be allergic to cyclophosphamide
  -  Life expectancy of less than 3 months
  -  No measurable lesions according to RECIST 1.1
  -  Eastern cooperative oncology group (ECOG) Performance status >2
  -  Major surgery less than 4 weeks prior to start of treatment
  -  Known human immunodeficiency virus (HIV) positivity
  -  A decreased renal function with calculated glomerular filtration rate (GFR) < 30ml/min
  -  Systemic anti-cancer therapy within 28 days prior to the first dose of study drug , or radiotherapy to a target lesion within 21 days prior to the first dose of study drug
  -  Pregnant or lactating women
  -  Other invasive malignancies diagnosed within the last 5 years, except non-melanoma skin cancer and localised cured prostate and cervical cancer

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

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

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: 81-year-old male with Prostate cancer. Genetic variant: PTEN Inactivating. Other conditions: Hypertension, Depression.

Clinical trial: Will Erectile Dysfunction Increase the Risk of Prostate Cancer

Summary: The rationale for investigating the hypothesis that there is an association between erectile dysfunction (ED) and the subsequent development of prostate cancer is based on three assumptions: 1) baseline ED is common in most if not all of the cross-sectional studies in men with prostate cancer; 2) the development of ED and prostate cancer may have certain shared common risk factors; and 3) the use of testosterone for the treatment of ED has been suspected to be associated with prostate cancer development. Controversy exists over whether men with ED have an increased risk of subsequent prostate cancer. Few studies have evaluated the risk of developing prostate cancer for men with ED. The investigators, therefore, conducted a population-based longitudinal study with eight years' follow-up to examine this association and to evaluate the magnitude of the risk.


Eligibility: Inclusion Criteria:
  -  men 50 years and older with no pre-existing prostate cancer
  Exclusion Criteria:
  -  less than 50 years old
  -  pre-existing prostate cancer

Relevance to patient case: not relevant