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: Image Guided Radiation Therapy For Prostate Cancer

Summary: During the 7 to 8 weeks of conformal radiotherapy for prostate carcinoma, the prostate has an intra-pelvic motion which is not detectable by the conventional portal imaging. This prostate motion may lead to a mistargeting, which possibly decreases the local control. On the other hand, the new 3D on board imaging (3D OBI) allows to localize the target but is expensive. The cost/effectiveness ratio is not well established, as well as the frequency of using such imaging during the course of radiation.


Eligibility: Inclusion Criteria:
  -  prostate adenocarcinoma
  -  intermediate / high risk group
  -  N0 or N -
  -  treatment by conformal radiotherapy (including or not IMRT), with or without androgen deprivation
  Exclusion Criteria:
  -  pelvic irradiation
  -  metal objects in the pelvis

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 Randomized Trial of External Beam Radiotherapy Versus Cryoablation in Patients With Localized Prostate Cancer

Summary: A trial to determine if cryoablation is as effective as radiation in the treatment of men with localized prostate cancer.

Detailed description: Men with newly diagnosed localized prostate cancer were randomly assigned to cryoablation or external beam radiotherapy (median dose 68 Gy). All patients received neoadjuvant antiandrogen therapy. The primary endpoint was disease progression at 36 months based on a trifecta definition of failure: (a) radiological evidence of metastatic disease or b) initiation of further antineoplastic therapy or c) biochemical failure). Two definitions of biochemical failure were used: 1) rising PSA with a final value >1.0 ng/mL and 2) rise above PSA nadir + 2 ng/mL. Secondary endpoints were overall survival, disease-specific survival, and positive prostate biopsy at 36 months.

Eligibility: Inclusion Criteria:
  -  Clinically localized prostate cancer
  -  PSA < 20ng/ml
  -  Negative bone scan
  Exclusion Criteria:
  -  Previous TURP
  -  Previous hormone therapy

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: Study of Everolimus (RAD001) in Patients With Recurrent Glioblastoma Multiforme (GBM)

Summary: This study will define the safety and efficacy of Everolimus (RAD001) administered daily in patients with glioblastoma multiforme (GBM)

Detailed description: This was a multicenter, open label, randomized study of RAD001 dosed daily in patients with recurrent GBM. The study was conducted with 2 parallel groups of patients. Group 1 was designed to study the biological effects of RAD001 in patients scheduled to undergo salvage surgical resection, and Group 2 was to enroll patients who were not scheduled for surgery. Patients in Group 1 were randomly assigned to one of three pre-surgery treatment groups (0, 5 or 10 mg/day RAD001 for 7 days). All patients in Group 2 were to receive a fixed daily dose of 10 mg/day oral RAD001.

Eligibility: Inclusion Criteria:
  -  Age 18 years of age or older
  -  Histologically confirmed Glioblastoma Multiforme (GBM)
  -  Radiographic evidence of disease progression
  -  Patients must have evaluable contrast enhancing tumor
  -  Availability of paraffin blocks or unstained pathology slides for biomarker studies
  -  Karnofsky Performance Status of greater than or equal to 60%
  Exclusion Criteria:
  -  Prior treatment with Mammalian target of rapamycin (mTOR) inhibitor
  -  History of another malignancy within 3 years
  -  Cardiac pacemaker
  -  Ferromagnetic metal implants other than those approves as safe for use in Magnetic resonance imaging (MRI) scanners
  -  Claustrophobia
  -  Obesity
  -  Unstable systemic diseases
  -  Elevated cholesterol or triglycerides
  -  Radiation therapy or cytotoxic chemotherapy <=4 weeks prior to study enrollment. Patient must have recovered from the toxic effects of a prior chemotherapy.
  -  Patients must be off all enzyme inducing anticonvulsants for at least 2 week before study enrollment can occur
  -  Need for increasing dose of steroids. Patients on a stable or tapering dose of steroids >=7 days were permitted.

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: Implant Radiation Therapy Using Radioactive Iodine in Treating Patients With Localized Prostate Cancer

Summary: RATIONALE: Implant radiation therapy delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.
  PURPOSE: This clinical trial is studying the side effects and how well implant radiation therapy using radioactive iodine works in treating patients with localized prostate cancer.

Detailed description: OBJECTIVES:
  -  To determine the efficacy of permanent brachytherapy with iodine I 125 seeds in patients with localized prostate cancer.
  -  To determine the safety of this therapy in these patients.
  OUTLINE: This is a multicenter study.
  Patients undergo permanent brachytherapy seed implantation comprised of iodine I 125 into the prostate. Some patients may receive combination treatment (e.g., external beam radiation therapy (EBRT) or hormone therapy in addition to brachytherapy).
  Quality of life and the International Prostate Symptom Score (IPSS) is assessed and compared.

Eligibility: DISEASE CHARACTERISTICS:
  -  Clinically and histologically confirmed localized prostate cancer
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  No prior or concurrent surgery
  -  No prior or concurrent radiotherapy
  -  Prior chemotherapy, hormonal therapy, and biologic therapy allowed

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: Bicalutamide Monotherapy Has Significant Quality of Life Benefits for Men With Advanced Prostate Cancer

Summary: The aim of this study is to comprehensively monitor the effects of a nonsteroidal antiandrogen in patients requiring hormone manipulation for prostate cancer

Detailed description: Androgen deprivation therapy is the mainstay of treatment for advanced prostate cancer. There is an increasing tendency towards earlier treatment with hormone manipulation. However, luteinizing hormone-releasing agonists decrease serum testosterone to castrate levels within two weeks of commencement.They are associated with loss of libido, loss of muscle bulk and accelerated bone loss. Osteoporotic patients are at high risk of fragility fractures. An alternative is the nonsteroidal antiandrogen bicalutamide which blocks testosterone at the receptor level, allowing androgen deprivation in the prostate without reducing circulating levels of testosterone. This should preserve the desired effects on other androgen-sensitive tissue, resulting in an advantageous side effect profile. The aim of our study is to closely monitor osteoporotic patients commencing bicalutamide for a period of 12 months. Patients will be reviewed in a dedicated prostate cancer clinic every 3 months. Patients will be questioned regarding adverse events. Renal and liver function tests, prostate specific antigen, testosterone, estradiol and bone turnover markers will be measured 3 monthly. Measurement of height , weight, body mass index, quadriceps strength using dynamometry, and skeletal mass using arm anthropometry (mid-arm circumference and triceps skinfold thickness), will be carried out 3 monthly. Quality of life issues will be assessed 3 monthly using the Rand 36-Item Health Survey (SF36) and University of California-Los Angeles Prostate Cancer Index (UCLAPCI). Patients will undergo bone densitometry of the forearm at baseline and 12 months.

Eligibility: Inclusion Criteria:
  -  Osteoporotic patients (T score ≤ -2.5) with advanced prostate cancer requiring hormone manipulation, due to biochemical relapse following either radical prostatectomy, radiotherapy, brachytherapy, or biochemical progression after initially being observed with prostate cancer.
  Exclusion Criteria:
  -  Severe hepatic insufficiency, with bilirubin above reference range
  -  Previous systemic therapy for prostate cancer
  -  Radiotherapy within 6 months
  -  Previous other invasive malignancies
  -  Any severe concomitant 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: Phase II Study of ASP3550 in Patients With Prostate Cancer

Summary: To assess the effect of ASP3550 on the maintenance of serum testosterone suppression in patients with prostate cancer

Detailed description: Two doses of ASP3550 were administered to patients with prostate cancer. The primary efficacy variable was the effect of ASP3550 on the maintenance of serum testosterone suppression. In addition, the safety and pharmacokinetics of ASP3550 will be investigated.

Eligibility: Inclusion Criteria:
  -  Is a male patient with histologically proven prostate cancer (adenocarcinoma) of all stages
  -  Is a patient in whom endocrine treatment is indicated. Patients with rising serum PSA after having prostatectomy or radiotherapy performed with curative intention may be included
  -  Has a serum testosterone level above 1.5 ng/mL at screening
  -  Has an ECOG (Eastern Co-operative Oncology Group) P.S. (Performance Status) score of 0 to 2
  Exclusion Criteria:
  -  Previous or present endocrine treatment for prostate cancer. However, patients who have undergone neoadjuvant/adjuvant endocrine therapy for a maximal duration of 6 months and in whom prostatectomy or radiotherapy was terminated at least 6 months preceding Screening Visit may be included
  -  Is being treated with a 5α-reductase inhibitor
  -  Is a candidate for curative therapy, i.e., radical prostatectomy or radiotherapy within 12 months
  -  Has concurrent or a history of severe asthma (defined as a need for daily treatment with inhalation steroids), anaphylactic reactions, severe urticaria and angioedema

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: Far Infrared Radiation Treatment for Prostate Cancer

Summary: A study to determine the use of far infrared radiation for the treatment of prostate cancer.

Detailed description: Our initial assessment indicates that electromagnetic radiation of the central nervous system, the viscera and the endocrine system has the potential to cure a number of diseases, including prostate cancer.

Eligibility: Inclusion Criteria:
  -  Persons with Prostate, Bladder or Testicular Cancer.
  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: Prostate Biomarker Study

Summary: Radical Prostatectomy (removal of the prostate) or radiation therapy provide excellent outcomes for patients with localized (confined to one area) disease, yet there is still no effective treatment once the disease has spread beyond the prostate gland. Typically, a serum PSA test is done to diagnose prostate cancer. Following diagnosis, a prostate biopsy and other tests help to classify the patient's disease according to the likelihood of a recurrence. However, these assessments are imperfect. There is a need to identify and evaluate prostate biomarkers that will provide exact information regarding the likelihood of a recurrence (prediction) of prostate cancer.

Detailed description: The Inter-SPORE Prostate Biomarkers Study (IPBS) was established to prospectively collect and analyze biological specimens to predict and validate outcomes after treatment for prostate cancer. The study population will consist of patients scheduled to receive standard of care therapy for localized prostate cancer, either radical prostatectomy (RP) or radiation therapy (XRT; includes external beam radiation, brachytherapy, or both). Seven hundred (700) patients (350 RP, 350 XRT) will be recruited from 11 SPORE sites over a two-year interval. We will collect serum, plasma, lymphocytes, and prostate tissue samples for distribution to collaborating biomarker validation sites at other prostate SPOREs, along with clinical and epidemiologic data.

Eligibility: Inclusion Criteria:
  -  Males, 35 years of age or older, with histologically confirmed prostate adenocarcinoma, that is clinically localized to the prostate gland.
  -  Biopsy performed at the SPORE institution.
  -  No prior therapy for prostate cancer (patients who receive neoadjuvant therapy after collection of blood and biopsy samples are eligible).
  -  The patient should have 2 or more cores involved with carcinoma. The minimum amount of tumor submitted should be 5 mm, or at least 40% of the core involved with tumor. (This amount can be made up from 2 positive cores if 1 core is insufficient).
  -  Patients with clinical stage T1-T2a NXM0 prostate cancer who elect to be treated with RP or XRT (includes external beam radiation, brachytherapy, or both) at the SPORE institution.
  -  Patients with a nomogram predicted 5-year probability of freedom from biochemical recurrence (Kattan 1998) of less than or equal to 85% (patients with intermediate risk of recurrence).
  -  Ability and willingness to sign informed consent
  Exclusion Criteria:
  -  Participation in a therapeutic clinical trial with an experimental agent.
  -  Previous cancer of any kind except non-melanoma skin cancer
  -  Previous surgical or minimally invasive treatment for enlarged prostate (e.g. TURP, TUNA, TUIP, laser, microwave)
  -  Use of anti-androgen drugs during the 6 months prior to diagnosis
  -  Use of 5-alpha-reductase inhibitors during the 6 months prior to diagnosis

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: Germline Alterations of Tumor Susceptibility Genes in New York Cancer Patients

Summary: The basic premise of this research proposal is to determine whether there is any significant association between germline polymorphisms and cancers of colon, bladder, breast, testicular, prostate, ovaries, kidney, lung, lymphoid organs, and head and neck. This is an exploratory study designed to generate hypotheses for further research.

Detailed description: To establish significant correlations between genetic polymorphisms and cancer, a largescale, systematic comparison of genetic alterations utilizing a case-control methodology is proposed. To date, such studies have been limited due to the large number of samples necessary for obtaining statistical significance, and the lack of rapid and accurate methods to screen for genetic polymorphisms. We propose to utilize an anonymized design to obtain DNA from residual material from routine diagnostic blood tests, to link these samples to a limited set of clinical variables, and to test for the frequency of candidate low-penetrance cancer susceptibility alleles. These data will be combined with similar data from a control group of age- and ethnically-matched volunteers for a related cohort study to be conducted separately. Polymorphisms to be screened for include those involving the genes PTEN, APC, TGF βR-I, BLM, CHK2, a p85 phosphoprotein, ATM, ER, PR, MCP-1, MPIF, CCR2/5, CCR3, and SULT1A1. Cancers to be included are breast, bladder, kidney,colon, testicular, lung, prostate, ovarian, lymphoid neoplasms, and head and neck carcinomas. Genes with SNPs known to be relevant for either the development or treatment of lymphoid malignancies will also be targeted. Specifically, candidate genes will be selected from 1) cytokine signaling, 2) DNA repair, and 3) apoptosis regulatory pathways.

Eligibility: Inclusion Criteria:
  -  Patients with a histologic diagnosis of cancer of the colon, breast, bladder, kidney, testicles, lungs, prostate, head and neck, or lymphoid organs, who have donated a diagnostic blood sample as either an inpatient or outpatient at MSKCC.
  -  All patients who have two or more histologic diagnoses of the same primary tumor type involving the above sites.
  -  Patients of Ashkenazi Jewish ancestry with a histologic diagnosis of cancer of any type.
  -  Samples ascertained as part of protocol 98-024A(1) are also eligible for ascertainment in this study.
  Exclusion Criteria:
  -  MSKCC patients without a histologic diagnosis of cancer of the breast, bladder, kidney, colon, testicles, lungs, prostate, or lymphoid malignancy (including all types of lymphoma) will not be eligible for the AMDeC sponsored component of the study.

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

Clinical trial: Assessing Depression in a Geriatric Cancer Population

Summary: The goal of this study is to learn more about how we measure depression in elderly cancer patients (patients aged 70 and older). Depression is one of the most common causes of emotional distress in the elderly and continues to be under-recognized. This is a problem because depression can have a negative impact on quality of life. The symptoms of depression are linked to poor health outcomes and higher costs of health care. In fact, depression is one of the top five concerns facing the elderly today.

Detailed description: We have a few questionnaires that have been used to measure depression, but we do not know how these measures work with people with cancer. This study will help us answer this question. To complete this study, we need people who may or may not be feeling down or depressed.
  If you choose to take part, you will be asked to do the following:
  1. Fill out questionnaires that ask about:
  -  Your age, eduction, race, and income
  -  Your mood
  In all, these questionnaires will take about 10 minutes to complete.
  2. Answer questions about your mood. This will also take about 10 minutes to complete.

Eligibility: Inclusion Criteria:
  1. Age 70 and older
  2. Diagnosis of early or late stage prostate cancer, or diagnosis of early or late stage breast cancer
  3. Actively engaged in one of the following cancer treatments: chemotherapy, radiation therapy, hormone therapy
  4. Able to provide informed consent
  5. Ability to converse, write and read English
  Exclusion Criteria:
  1.Major psychopathology or cognitive impairment likely in the judgment of the research staff to interfere with the participation or completion of the protocol.

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: Prostatic Acid Phosphatase (PAP) Vaccine in Patients With Prostate Cancer

Summary: The investigators are trying to find new methods to treat prostate cancer. The approach they investigators are taking is to try to enhance patients own immune response against the cancer. In this study the investigators will be testing the safety of a vaccine that may be able to help the body fight prostate cancer.

Detailed description: The purpose of this research is to determine the safety of serial intradermal vaccinations of a DNA vaccine encoding human PAP, with GM-CSF as a vaccine adjuvant, in subjects with stage D0 prostate cancer. In addition, to determine whether PAP-specific IFNУ-secreting CD8+ T cells can be augmented in subjects with stage D0 prostate cancer by means of immunization with a plasmid DNA vaccine encoding PAP.
  This is a phase I design where patients will receive the vaccine pTVG-HP with rhGM-CSF administered i.d. biweekly for 6 total doses. There will be three escalating dose cohorts. The dosing cohort considered to be the maximum tolerated dose level will be expanded up to a total of 16 patients.

Eligibility: Inclusion Criteria:
  -  Must have histologic diagnosis of adenocarcinoma of the prostate
  -  Must have completed local therapy by surgery and/or ablative radiation therapy at least 2 months prior to entry.
  -  Must have clinical stage D0 disease defined by the following: In patients treated by surgery, serum PSA values must be > 2 ng/ml by two measurements at least two weeks apart. In patients treated with ablative radiation therapy, three consecutive increases in serum PSA must be documented, with at least a one month interval between values with the finalPSA > 2ng/ml.
  -  Prior history of a second malignancy is allowed if treated with curative intent disease free for > 5 years.
  -  Karnofsky performance score of > 70
  Exclusion Criteria:
  -  No evidence of immunosuppression or have been treated with immunosuppressive therapy, such as chemotherapy, chronic treatment dose corticosteroids (greater than the equivalent of 10 mg prednisone per day), or radiation therapy to >30% of the bone marrow, within 6 months of the first vaccination.
  -  Must not be on concurrent androgen ablative (hormonal) therapy, or must have completed this therapy at least one month prior to study entry.
  -  Must not have demonstrated PSA progression during any prior hormonal therapy or chemotherapy.
  -  Must not have known evidence of bone metastases or non-regional lymph node involvement (stage D2 disease) as determined by bone scan or CT scan. -Must not have been treated previously with another investigational anti- tumor vaccine.

Relevance to patient case: not relevant