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: A Study to Test if Enzalutamide is Effective and Safe in Prostate Cancer Patients Who Have Never Had Hormone Therapy

Summary: To evaluate the effect of enzalutamide on prostate specific antigen (PSA) level in men with prostate cancer.


Eligibility: Inclusion Criteria:
  -  Histologically confirmed prostate cancer (all stages) for whom androgen deprivation therapy is indicated (except when indicated in a neoadjuvant/adjuvant therapy)
  -  Asymptomatic from prostate cancer
  -  Non-castrate level of testosterone (≥ 8 nmol/L (230 ng/dL)) at screening
  -  PSA ≥ 2 ng/mL at screening
  Exclusion Criteria:
  Has previously or is currently receiving:
  -  Hormonal therapy with intent to treat prostate cancer
  -  Systemic glucocorticoids
  -  Chemotherapy with the intent to treat prostate cancer
  -  Opiate analgesics for pain from prostate cancer
  -  Radiation therapy for treatment of the primary tumor or metastases
  -  Has history of known or suspected brain or skull metastases or leptomeningeal disease
  -  Has history of seizure including febrile seizure or any condition that may predispose to seizure or history of loss of consciousness or transient ischemic attack
  -  Clinically significant cardiovascular disease

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: Assessing DNA Changes in High Risk Prostate Cancer to Determine Prognosis

Summary: One of the biggest problems facing prostate cancer patients and their treating physicians is who needs to be treated and when. Common clinical and pathological parameters are useful (PSA, Gleason score, etc.) but do not clearly predict who will benefit from treatment and who will fail. Genetic markers for tumor aggressivity would be of greater value. The finding that the TMPRSS2-ERG gene fusion is associated with an increase risk of cancer progression is important. TMPRSS2 is controlled by androgen (testosterone) and ERG is part of a family of proteins which have a role in controlling cell growth, cell specialization and producing tumors. As a consequence of this gene fusion, production of the ERG protein increases in the presence of testosterone and could be key to the development of prostate cancer, resistance to treatment and poor outcome. The PTEN gene is known to have a role as a tumor suppressor. Its deletion is a contributing factor in the development of prostate cancers and poor outcome. The coexistence of the two markers could be associated with a higher risk of recurrence.
  To date there have been no studies regarding the presence of either of these two markers or their coexistence in high risk prostate cancer patients who, despite radiation therapy and androgen suppression, develop biochemical failure (their PSA levels rise once again). Patients participating in the PCS IV study (high risk prostate cancer treated with radiation therapy plus either 18 or 36 months of hormonal suppression) who have had biochemical failure or 3 years of follow-up post hormonal therapy will be approached.
  Tumor blocks from consenting patients will be collected and analyzed for the presence of the TMPRSS2-ERG gene fusion and the PTEN deletion at the Pathology Department of the Jewish General Hospital. Statistical analysis will be carried out to see whether either or both markers are present, whether they are associated with certain clinical and pathological high risk factors, and whether they can be used to predict which patients will fail treatment.


Eligibility: Inclusion Criteria:
  -  patients with prostate cancer post radical radiation therapy and LHRH agonist treated in PCSIV clinical trial
  -  biochemical failure (PSA nadir + 2) or minimum follow-up of 3 years post completion of hormonal therapy
  -  high risk group
  1. gleason score 8-10
  2. PSA ≥ 20 ng/ml
  3. T3 or T4

Relevance to patient case: definitely relevant
Patient case: 81-year-old male with Prostate cancer. Genetic variant: PTEN Inactivating. Other conditions: Hypertension, Depression.

Clinical trial: Korean Practice Patterns for Screening PCA(Prostate Cancer)

Summary: This is to investigate Korean urologist's practice patterns for screening prostate cancer according to PSA level.

Detailed description: This is to investigate Korean urologist's practice patterns for screening prostate cancer according to PSA level.

Eligibility: Inclusion Criteria:
  -  Male with PSA more than 2.5ng/ml from 1 Jan 2008 to 31 Dec 2008
  Exclusion Criteria:
  -  Age less than 40 at PSA screening
  -  History of drug use which can affect level of PSA within 6months before PSA screening
  -  Subject who participate any other 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: Cryotherapy With or Without Short-term Adjuvant Androgen-Deprivation Therapy in Prostate Cancer

Summary: This is an open-label randomized clinical study comparing primary prostate cryoablation alone (No-ADT group) with cryoablation plus short-term adjuvant androgen-deprivation therapy (Adj-ADT group) in the treatment of patients with high-risk localized prostate cancer.

Detailed description: Subjects (N=182) who have high-risk prostate cancer and have undergone primary prostate cryotherapy will be screened and randomized in a 1:1 ratio to receive either adjuvant ADT (Adj-ADT) or No-ADT until disease progression. Screening and randomization will be done within four weeks after cryoablation. Only those who are assigned to Adj-ADT will receive ADT for a total of 12 months. PSA will be checked every 3 months in the first year after Cryo and every 6 months thereafter. Long-term follow-up parameters include serum PSA and protocol-mandated biopsies (at 36 months after Cryo, irrespective of PSA levels if recurrence has not been documented). For-cause biopsy will also be done if post-Cryo PSA elevation reaches the Phoenix criteria (Nadir + 2 ng/ml) or when the treating physician thinks it necessary to document tumor recurrence.

Eligibility: Inclusion Criteria:
  1. Age>20 years
  2. Histopathology proven prostate adenocarcinoma
  3. Non-metastatic localized disease
  4. Prostate cancer is deemed high-risk for recurrence(PSA>20 ng/ml, Gleason score>=8, or clinical staging>=T2c)
  5. Subjects have undergone prostate cryoablation as the definitive treatment prior to enrolling the study
  6. Subjects who have not been treated with any definitive treatments for prostate cancer, including radical prostatectomy or definitive radiotherapy. However, those who have undergone focal prostate cryoablation and have cancer recurrence are still eligible.
  7. Subjects may or may not have received neoadjuvant androgen-deprivation therapy (ADT) in the forms of either castration (medical) and/or antiandrogens. Surgical castration (orchiectomy) is not allowed.
  8. Subjects are willing to sign the informed consent and agree to comply with the study procedures
  Exclusion Criteria:
  1. Those who have been treated with > 8 weeks (collectively if not continuously) of neoadjuvant ADT prior to screening.
  2. Subjects who have other cancer that is deemed not cured or are known less than 5 years except for basal cell carcinoma of the skin
  3. Other conditions the investigators think may affect subject compliance or safety

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: Conventional Ultrasound for Imaging of Prostate Cancer Extent and Response in Human Cancer Patients

Summary: In this observational study the investigators will undertake imaging studies on men with prostate cancer. The primary hypothesis is that ultrasound spectroscopy could be used to determine the extent of disease inside and outside of the prostate gland in patients with prostate cancer. It is hoped that the changes in ultrasound backscatter parameters obtained before radical prostatectomy could be used to correlate with pathological findings from the prostate specimen after surgery.

Detailed description: This project is an early validation study in human subjects that will use ultrasound imaging and spectroscopy to predict the tumour extent before treatment so that this may allow the most appropriate treatment intervention to be individualised to patients. For examples, patients with evidence of extra-prostatic tissue involvement may be best served with definitive radiation therapy rather than radical prostatectomy as surgery alone in this situation, is not optimum. Furthermore, these ultrasound parameters may be used to monitor cell death occurring at various time points during patients' radiation treatment for prostate cancer.
  The research is exploratory since upon data analysis it will examine the use of different ultrasound parameters as potential markers of pre-treatment tumour extent and cell death, and correlate these with tumour shrinkage and complete pathological response. Sensitivity and specificity values for the various ultrasound parameters will be calculated for the different time points used and receiver-operator curves will be generated. From this data the investigators will potentially estimate the best time-points at which to make a prediction about patient response and the best ultrasound-spectroscopy variables to use for this purpose.

Eligibility: Inclusion Criteria:
  -  Prostate Cancer
  Exclusion Criteria:
  -  Not having radical prostatectomy surgery

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: Effects of Controlled Ovarian Hyperstimulation (COH) With Letrozole and Gonadotropin

Summary: Fertility drugs have the effect of increasing hormone levels. Higher hormone levels from infertility treatments may increase breast cancer risk, but there has not been enough research to know for sure. Researchers want to use a method of taking breast tissue cells from women who are having infertility treatment. The breast tissue cells might show changes that would indicate an increased risk of cancer. The method of taking the breast tissue cells is called Fine Needle Aspiration (FNA).
  The purpose of this study is to examine the changes in breast tissue, in women at high risk of breast cancer who are being treated with controlled ovarian hyperstimulation.


Eligibility: Inclusion criteria:
  1. Women must be at increased risk for breast cancer based on any of the following criteria:
  -  Age 30 or older with no prior live birth.
  -  Mutations associated with hereditary cancer (BRCA1 or 2, P53, PTEN)
  -  Family history of breast cancer including one first degree or multiple second degree relatives
  -  History of chest radiation before age 30
  -  Multiple prior breast biopsies
  -  Precancerous conditions (DCIS, LCIS, AH)
  -  Prior history of breast or ovarian cancer
  -  Estimated mammographic breast density > 50%
  2. Must be undergoing infertility treatment at the University of Kansas with Controlled Ovarian Hyper-stimulation (COH)
  3. Must be between the ages of 21-45 (both inclusive) with Day 3 FSH less than 12 IU/L, Day 3 E2 less than 80 pg/ml
  Exclusion criteria:
  1. Women under 21 or over 45 years old
  2. Day 3 FSH over 12 IU/L, Day 3 E2 over 80 pg/ml
  3. Women who do not meet risk criteria above
  4. History of hypersensitivity to letrozole or gonadotropin
  5. Uterine and adnexal pathology
  6. Use of clomid or gonadotropin within 30days before the letrozole cycle
  7. Any severe chronic disease of relevance for reproductive function

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-specific Membrane Antigen Antibody-Drug Conjugate in Subjects With Prostate Cancer

Summary: Prostate-specific Membrane Antigen Antibody-Drug Conjugate (PSMA ADC) 1301 is an open-label, dose-escalation phase 1 study of PSMA ADC administered IV in subjects with progressive, castration-resistant, metastatic prostate cancer that has progressed after prior taxane therapy. For all subjects, PSMA ADC will be administered in four repeating cycles.


Eligibility: Inclusion Criteria:
  1. A diagnosis of progressive, castration-resistant, metastatic prostate cancer.
  2. Prior chemotherapy regimens, one of which contains taxane.
  3. Eastern Cooperative Oncology Group status of 0 or 1
  Exclusion Criteria:
  1. Clinically significant cardiac disease or severe debilitation pulmonary disease
  2. Evidence of an active infection requiring ongoing antibiotic therapy
  3. Any prior treatment with any other therapy targeting PSMA
  4. History of drug and/or alcohol abuse

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 Education in African American Men

Summary: This study evaluates the efficacy of a tailored telephone intervention to promote informed decision making about prostate cancer testing among predominantly immigrant black men.

Detailed description: African American and African-Caribbean men have the greatest prostate cancer incidence and mortality rate. Professional organizations provide conflicting recommendations regarding prostate cancer testing but generally agree that men learn about the risks and benefits of testing and share in decisions about testing based on their personal preferences. This study was designed to assess the effects of a decision support intervention on men's knowledge about prostate cancer testing, participation in medical decisions about testing, decision conflict related to testing, and the congruence between prostate cancer testing intentions and behaviors. A randomized controlled trial was conducted. Participants were randomized into one of two conditions: (a) tailored telephone education about prostate cancer testing (intervention group) or (b) tailored telephone education about national guidelines for fruit and vegetable consumption (attention control group).

Eligibility: Inclusion Criteria:
  -  45 to 70 year old
  -  African descent
  -  accessible by telephone
  -  have primary care physician
  Exclusion Criteria:
  -  Prostate cancer test in 12 months prior to enrollment
  -  History of prostate 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: Safety and Tolerability of ODM-201 in Castrate Resistant Prostate Cancer; Extension Study to Study 3104001

Summary: The purpose of this study is to evaluate safety and tolerability of ODM-201 in patients with castrate resistant prostate cancer.


Eligibility: Inclusion Criteria:
  -  Written informed consent
  -  Successful completion of study protocol 3104001
  -  Response or stable disease in study 3104001 at week 12
  Exclusion Criteria:
  -  New serious concurrent medical condition
  -  Not able to swallow the study drug

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: Dose-Escalation and Safety Study of APC-100 for the Treatment of Prostate Cancer

Summary: This study is a phase 1/2a, open label, dose escalation and safety study of APC-100 (2,2,5,7,8-Pentamethyl-6-chromanol) in men with advanced prostate cancer.


Eligibility: Inclusion Criteria:
  -  Patients with histopathologically proven adenocarcinoma of the prostate
  -  Patients must have progressive disease
  -  Patients must have had prior treatment with bilateral orchiectomy or androgen deprivation therapy with an LHRH-blocker with evidence of treatment failure
  Exclusion Criteria:
  -  Patients treated with other secondary hormonal therapies
  -  Patients with prior chemotherapy given for castrate-resistant prostate cancer
  -  Patients with prior radiation therapy completed less than 4 weeks prior enrollment
  -  Patients with prior investigational therapies within 4 weeks before treatment with APC-100
  -  Evidence of active second malignancy

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: Genetics, Brain Structure and Thinking Skills in Autism

Summary: The purpose of this research is to better understand the genetic, biochemical, cognitive and behavioral symptom abnormalities that contribute to autism spectrum disorders. The investigators anticipate recruiting at least 100 participants with autism spectrum disorder and large head size, at least 100 participants with autism spectrum disorder without large head size and at least 40 healthy siblings. Biological parents are expected to be recruited only as genetic changes are identified in individuals with autism spectrum disorders to better understand the nature of these genetic changes. Participants are asked to complete cognitive testing, a blood draw, urine collection and measurement of his/her height, weight and head circumference. Parents or caregivers may be asked to complete a diagnostic evaluation and will complete questionnaires that examine the participant's medical and family history as well as his/her current symptoms, functioning, and quality of life. A brief report simply listing and giving a basic description of any behavioral diagnostic information, autism symptoms, adaptive functioning, and a listing of results from cognitive testing will be provided as part of this study.


Eligibility: Inclusion Criteria:
  -  Clinical diagnosis of autism
  -  Consent from parents or guardians or an adult with or suspected of having an autism spectrum disorder that does not require a legal guardian or an adult who is the healthy sibling of an individual with an autism spectrum disorder.
  -  Youth ages 2-17 and adults ages 18-50. Youths and adults who are able (some young or severely impaired participants may not be able to provide assent) will be asked to provide assent.
  -  Families with multiple children who meet the above inclusion criteria will be permitted to have as many children participate as they wish.
  -  Youth ages 2-17 and adults ages 18-50 who do not have an autism spectrum disorder or are not suspected of having an autism spectrum disorder and who have a sibling with an autism spectrum disorder who has participated in the present study.
  Exclusion Criteria:
  -  Clinically significant medical disease that would prohibit participation in the study procedures.
  -  Children younger than 2 years old and adults older than 50 years old.

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: Biomarkers in Patients With Metastatic or Recurrent Head and Neck Cancer Treated With Cisplatin and Cetuximab on ECOG-E5397

Summary: RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors predict how well patients will respond to treatment.
  PURPOSE: This research study is studying biomarkers in patients with metastatic or recurrent head and neck cancer treated with cisplatin and cetuximab on ECOG-E5397.

Detailed description: OBJECTIVES:
  Primary
  -  Compare cetuximab activity, as reflected in response rate (RR), in PTEN-deficient and PTEN-expressing cancers.
  Secondary
  -  Examine RR, progression-free survival (PFS), and overall survival (OS) in PTEN-deficient and PTEN-expressing cancers, by treatment arm.
  OUTLINE: Tissue microarray slides collected earlier from ECOG-E5397 are immunostained with PTEN antibody and analyzed with AQUA.

Eligibility: DISEASE CHARACTERISTICS:
  -  Treated on protocol ECOG-E5397
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

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: An Evaluation of Polymer Based Fiducials for Use in Imaging Patients Receiving Treatment for Prostate Cancer

Summary: This trial is to determine if prostate target delineation obtained through an ultrasound based system is equivalent in accuracy to the MRI image fusion, and if alignment correction vectors obtained from ultrasound imaging are of equivalent accuracy to orthogonal X-ray imaging for daily prostate positioning.

Detailed description: The investigators will also be assessing the following:
  1. Whether polymer-based markers can be adequately visualized on daily stereoscopic imaging compared to gold seed markers.
  2. Whether polymer-based markers are visible on ultrasound imaging.
  3. To determine if the polymer-based marker produces fewer artifacts on treatment planning CT scans than gold markers.

Eligibility: Inclusion Criteria:
  -  Histologically confirmed prostate adenocarcinoma
  -  diagnosis of low risk or intermediate risk prostate cancer
  -  approved for proton therapy treatment at CDH ProCure Proton Therapy Center
  -  prescribed and consented for the placement of fiducial markers into the prostate as part of the standard treatment procedure
  -  capable of receiving an MRI of the pelvis region for prostate localization
  -  the prostate gland of eligible patients must be capable of imaging from an anterior trans-abdominal ultrasound as determined by the treating investigator
  -  must be fluent in the English language; must be able to provide written study consent
  Exclusion Criteria:
  -  Evidence of a large TURP defect per investigator discretion
  -  previous prostate cancer surgery including prostatectomy, hyperthermia and cryosurgery
  -  previous pelvic radiation for prostate cancer
  -  current grade 2 or above incontinence
  -  history of orthopedic procedures in the area of the treatment, specifically no prior hip replacement or procedure in which metallic or high density material remains which would be within stereoscopic kilovoltage imaging area
  -  prior permanent placement of any metallic or high density material within the prostate
  -  known allergy to ultrasonic gel

Relevance to patient case: not relevant