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: MRI/MRSI in Risk Assessment of Prostate Cancer Patients

Summary: The purpose of this study is to see if magnetic resonance imaging (MRI) and magnetic resonance spectroscopic imaging (MRSI) can tell which patients with prostate cancer are at a low risk for their cancer growing and spreading. Magnetic resonance methods use magnets and radio waves to take pictures of body structure (MRI) and to measure amounts of important chemicals within the body (MRSI). This study will look at the structural and chemical properties of prostates before undergoing treatment. Hopefully, doctors will be able to use this method before making treatment decisions for patients with newly diagnosed cancer of the prostate. This study will continue our work to assess the value of MRI/MRSI in addressing what is currently one of the greatest clinical challenges in the management of prostate cancer: the identification of low-risk organ-confined prostate cancer that can be managed expectantly with deferred treatment.

Detailed description: In this study, patients with low-risk, organ-confined prostate cancer identified in clinic or prior to their already scheduled standard of care MRI in the Department of Radiology will be approached for the study. Eligible patients will undergo a baseline eMRI/MRSI exam between 6 and 24 weeks following biopsy. Patients will undergo definitive treatment (radical prostatectomy (RP) or radiation therapy (RT)) or will be placed on deferred therapy. Predictor variables will be recorded for each patient after enrollment, before treatment and during treatment follow-up. Patient outcome-disease progression will be determined by long term clinical follow-up

Eligibility: Inclusion Criteria:
  1. Gleason ≤6 (grade 3 + 3 or lower) biopsy proven prostate cancer
  2. Clinically low-risk localized disease as defined by NCCN guidelines (clinical stage T1-T2a, maximum Gleason score 2-6, peak serum PSA level < 10 ng/ml)
  3. No evidence of disseminated disease (bone or lymph node metastases)
  4. Treatment—radical prostatectomy, radiation therapy, or deferred therapy—will be at MSKCC
  5. Willingness to undergo serial surveillance TRUS-guided prostate biopsies and eMRI/MRSI examination at MSKCC if placed on deferred therapy protocol
  6. In the surgical cohort, RP (radical prostatectomy) is scheduled to occur within six months of eMRI/MRSI study
  Exclusion Criteria:
  1. Prior treatment (e.g. with hormonal therapy, radical prostatectomy, radiation therapy or cryosurgery)
  2. Inability to give informed consent because of age, general medical or psychiatric condition, or physiologic status
  3. Presence of known contraindication to eMRI
  4. Unwillingness or inability to undergo placement of endorectal MR coil or ultrasound probe. As is the case for a standard MR exam, the presence of a pacemaker or aneurysm clips could pose a risk to patients, making them unable to have an eMRI, and therefore unable to participate in this 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: A Phase III Trial of ZD4054 (Zibotentan) (Endothelin A Antagonist) and Docetaxel in Metastatic Hormone Resistant Prostate Cancer

Summary: Enthuse M1C is a large phase III clinical trial studying the safety and efficacy of ZD4054 (Zibotentan) in combination with docetaxel (Taxotere) in patients with metastatic hormone resistant prostate cancer (HRPC).
  This clinical trial will test if the Endothelin A Receptor Antagonist ZD4054 (Zibotentan) can further improve survival compared with docetaxel alone.
  ZD4054 (Zibotentan) is a new type of agent, which is thought to slow tumour growth and spread by blocking Endothelin A receptor activity. This trial will look at the effects of ZD4054 (Zibotentan) in hormone resistant prostate cancer patients with bone metastases compared with docetaxel.
  All patients participating in this clinical trial will receive docetaxel chemotherapy, which is a commonly used chemotherapy to treat prostate cancer in addition to other existing prostate cancer therapies.
  Half the patients will receive ZD4054 (Zibotentan), and half the patients will receive placebo in addition to docetaxel and other prostate cancer therapy. By participating in this trial there is a 50% chance that patients will receive an agent that may further slow the progression of the tumour.
  No patients will be deprived of standard prostate cancer therapy.


Eligibility: Inclusion Criteria:
  Patients who answer TRUE to the following criteria may be eligible to participate in this trial.
  -  Confirmed diagnosis of prostate cancer (adenocarcinoma of the prostate) that has spread to the bone (bone metastasis)
  -  Increasing Prostate Specific Antigen (PSA), collected within one year of enrollment
  -  Currently receiving treatment with surgical or medical castration
  Exclusion Criteria:
  Patients who answer TRUE to the following ARE NOT eligible to participate in this trial.
  -  Previous treatment with chemotherapy (paclitaxel, docetaxel, and mitoxantrone). Prior targeted cancer therapies are permitted if received during a previous clinical trial.
  -  Suffering from heart failure or had a myocardial infarction within last 6 months
  -  A history of epilepsy or seizures

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: Everolimus in Treating Patients With Relapsed or Refractory Multiple Myeloma

Summary: RATIONALE: Everolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer.
  PURPOSE: This phase II trial is studying how well everolimus works in treating patients with relapsed or refractory multiple myeloma.

Detailed description: OBJECTIVES:
  Primary
  -  To assess the response rate in patients with relapsed or refractory multiple myeloma treated with everolimus.
  Secondary
  -  To evaluate the toxicity of everolimus in patients with multiple myeloma.
  -  To study the tumor cells and blood from patients entering this trial for laboratory correlates.
  OUTLINE: Patients receive oral everolimus once daily on days 1-28. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.
  Patients undergo bone marrow aspirate, biopsy, and blood sample collections periodically. Samples are assessed for the following: cyclin D1, phospho-AKT, phospho-p70 S6 kinase, and phospho-S6 by western blot; checkpoint regulators PTEN, p53, pRB, and p27 by immunoblotting; p53, Rb, p16, PTEN, p27, and cyclin D1 by DNA analysis; caspases 3 and 9 by immunoblotting and Annexin/PI by flow cytometry; unknown molecular markers by protein profiling; and microvessel density.
  After completion of study treatment, patients are followed every 3-6 months for up to 2 years.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of multiple myeloma, meeting 1 of the following criteria:
  -  Monoclonal protein in the serum of ≥ 1 g/dL
  -  Monoclonal light chain in the urine protein electrophoresis of ≥ 200 mg/24 hours
  -  Measurable light chains by free light chain assay of ≥ 10 mg/dL
  -  Measurable plasmacytoma
  -  Must have received prior therapy and have relapsed or refractory disease
  PATIENT CHARACTERISTICS:
  -  ECOG performance status 0-2
  -  Life expectancy ≥ 12 weeks
  -  ANC ≥ 1,000/mm³
  -  Platelet count ≥ 75,000/mm³
  -  Hemoglobin ≥ 8.0 g/dL
  -  Total bilirubin ≤ 2.0 mg/dL (if total bilirubin is elevated, direct bilirubin must be normal)
  -  AST ≤ 3 times upper limit of normal (ULN)
  -  Creatinine ≤ 1.5 times ULN
  -  Calcium < 11 mg/dL
  -  No uncontrolled infection
  -  Not pregnant or nursing
  -  Negative pregnancy test
  -  Fertile patients must use effective contraception
  -  No HIV positivity
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics
  -  At least 3 weeks since prior cytotoxic chemotherapy
  -  At least 2 weeks since prior biologic therapy or radiotherapy
  -  At least 2 weeks since prior corticosteroids
  -  Concurrent chronic corticosteroids allowed for treatment of disorders other than myeloma
  -  No other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational

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 Sorafenib and Docetaxel in Metastatic Prostate Cancer

Summary: The purpose of this study is to use Sorafenib plus Docetaxel to evaluate pharmacodynamics (PD) in Patients with prostate cancer.

Detailed description: Background Prostate cancer is the most common malignancy in men and the second leading cause of cancer death among males in the Western World. When tumors become refractory to androgen withdrawal therapy, chemotherapy represent a palliative treatment with an improvement on quality of life, particularly the combination of mitoxantrone and prednisone . This observation has led to numerous studies evaluating the potential use of new chemotherapeutic agents as Docetaxel in patients with metastatic androgen independent prostate cancer. Recently Docetaxel based regimens have shown an improvement in survival when compared with mitoxantrone in a phase III trial .
  However the prognosis of these patients remains very poor and new effective tolerated approaches are needed to improve the results of chemotherapy.
  Rationale In a recent study a Raf kinase inhibitor protein (RKIP) encoded by a suppressor gene was found to be responsible of the metastatic process; in fact the decreased RKIP expression was associated with increased invasive capability of prostate cancer cells, presumably though the activation of MEK and ERK by phosphorilation .
  Sorafenib, a novel signal transduction inhibitor, prevents tumor cell proliferation and angiogenesis blocking Raf/Mek/Erk pathway at the level of Raf kinase and tyrosine kinase receptors VEGFR-2 and PDGFR.
  In a phase I study the combination of docetaxel and Sorafenib was evaluated in prostate and other tumors . The treatment was well tolerated and one partial response (4%) and 12 stable disease (50%) were reported.
  According to these data we designed a phase II study to evaluate the association of Sorafenib and Docetaxel in metastatic prostate cancer
  Simon's Optimal two-stage design for phase II clinical trial will be applied to calculate the sample size that minimizes the expected number of patients to be accrued. The sample size will be calculated on the following assumptions: alpha error =0.05, beta error =0.20; PD (clinically uninteresting true no progressive disease rate) and P1 (sufficiently promising true no progressive disease rate) will be set at 60% and 80%. 11 patients will be enrolled in the first stage: if no progressive diseases are < 7 the accrual will be stopped and the drug's combination rejected. In the case of >= 7 no progressive diseases 32 more patients will be accrued at the second stage. The treatment will be accepted if >= 30 no progressive diseases out of 43 patients will be observed

Eligibility: Inclusion Criteria:
  -  Patients with metastatic hormone refractory 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: Molecular, Genetic, and Genomic Assessments From Patients Treated With RAD001

Summary: The purpose of this study is to look at the genetic changes that RAD001 causes in prostate cancer cells and how those changes relate to patients' response to RAD001 treatment.

Detailed description: This correlative science study will be a minimum risk assessment of tumor and plasma samples collected as part of a Phase II clinical trial of RAD001 in patients with HRPC. Prior to enrollment or at the time of signing consent in the Phase II trial, patients will be approached to participate in the correlative science study. Patients who agree to participate will be assigned a separate study number which will be used to identify their molecular, genetic, genomic and biomarker assessments using the tumor and plasma samples. Clinical outcome results from the accompanying Phase II trial will be used for correlative assessments in this study, however, results from this correlative science study will be kept separate from the assessments and reporting of the clinical trial.

Eligibility: Inclusion Criteria:
  -  Patients must be enrolled in the clinical study entitled: A Single Arm, Phase II Study of RAD001 in Patients with Metastatic, Hormone-Refractory Prostate Cancer at the time of enrollment onto this 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: Casodex - Nolvadex Combination

Summary: This study looks at the relationship in the dose of nolvadex and the incidence of gynaecomastia and also Prostate Specific Antigen (PSA) inhibition when co-administered with Casodex. The aim of the study is to assess the optimal dose of nolvadex which will reduce the breast tissue adverse effects without reducing the efficacy of Casodex.


Eligibility: Inclusion Criteria:
  -  Subjects with adenocarcinoma of the prostate gland but with no evidence of distant metastasis. The stage of disease should be T1-T4, any N, M0 confirmed histologically or cytologically
  -  Subjects in need of immediate hormonal therapy.
  -  PSA equal or above 4 ng/ml
  Exclusion Criteria:
  -  Presence of gynaecomastia and/or breast pain at screening visit
  -  Any previous endocrine therapy for prostate cancer other than neoadjuvant LHRH therapy prior to primary therapy of curative intent.
  -  Current use, or within the previous 6 months, of any medication known to have a high risk of causing gynaecomastia .
  -  Previous mastectomy or radiation to chest wall

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 Phase I Study of BMS-641988 in Japanese Patients With Castration Resistant Prostate Cancer

Summary: The purpose of this clinical study is to assess the safety and tolerability of BMS-641988 once daily orally in Japanese patients with castration resistant prostate cancer


Eligibility: Inclusion Criteria:
  -  Patients with castration-resistant prostate cancer and serum testosterone ≤50 ng/dL progressive to current therapy who satisfy the inclusion and 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: Cardiovascular Evaluation of Adult PHA 1 Patients

Summary: Vascular and cardiac alterations are associated with aldosterone effects are evidenced in experimental models and aldosterone receptor blockade is of clear benefit in cardiac disease (heart failure). The study aims at assessing vascular and cardiac alterations in adults with a chronic increase in circulating aldosterone without hypertension. The investigated population will be patients with a rare disease, pseudohypoaldosteronism type 1, due to heterozygous inactivating mutations of the mineralocorticoid receptor.

Detailed description: The study includes adult patients with mineralocorticoid receptor mutation as compared with not affected relatives. It includes also relatives of adult relative of patients with PHA1 in whom no mutation was found. Cardiovascular evaluation is conducted with cardiac and vascular ultrasound assessment and cardiac NMR, ambulatory blood pressure measurement.
  Protocol duration is 2 days . Detailed genetic study is conducted in family without identified mutation in MINERALORECEPTOR.

Eligibility: Inclusion criteria:
  -  Age over 18
  -  Male or female gender
  -  Genotype in the PHA1.NET network
  Exclusion criteria:
  -  Not membership to a regime of Social Security or to a CMU
  -  Against indication in the realization of a MRI
  -  Cardiac NMR not possible
  -  Known cardiovascular disease for person not carrying MR mutation

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 (Casodex™) Versus Placebo in Patients With Early Prostate Cancer

Summary: The purpose of this trial is to study the effect - in terms of time to progression and overall survival - of 2 years of adjuvant bicalutamide 150mg monotherapy, versus placebo, in subjects with histologically or cytologically confirmed non-metastatic adenocarcinoma of the prostate gland.


Eligibility: Inclusion Criteria:
  -  Prostate cancer in the early stage of disease
  -  Prostate removed and/or radiation therapy to the prostate area
  Exclusion Criteria:
  -  Previous systemic therapy for prostate cancer
  -  Previous history of another form of cancer (not prostate) within 5 years of study start.

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: Lower Urinary Tract and Sexual Function in Women Following Surgery for Colorectal Disorders

Summary: This is a prevalence study evaluating lower urinary tract, prolapse, bowel, and sexual symptoms in women with a colorectal disorder who are planning to undergo surgery.
  The purpose of this study is to identify the number of women who complain of lower urinary tract and bowel problems, including frequency, urgency, urinary incontinence, fecal incontinence, pain with intercourse, and other sexual problems prior to undergoing surgical management for a colorectal disorder.

Detailed description: Lower urinary tract symptoms, including urinary incontinence, voiding dysfunction, urgency, frequency, fecal incontinence, as well as sexual dysfunction, are directly affected by surgery for colorectal disorders. Increased risk of injury to the urinary tract is a recognized complication of pelvic surgery. These risks are related to the radical nature of pelvic surgery used to treat certain colorectal disorders, including colorectal malignancies and inflammatory bowel disease.
  Few studies have looked at the incidence of lower urinary tract symptoms and sexual dysfunction in patients with colorectal conditions before and after surgery.
  The primary goal of this study is to determine the prevalence of lower urinary tract symptoms in women undergoing surgery for colorectal ocnditions. We also want to describe the prevalence of these symptoms in different colorectal disorders, and how pelvic surgery impacts these symptoms.

Eligibility: Inclusion Criteria:
  -  Female subjects with a diagnosis of a colorectal disorder, including rectal prolapse, inflammatory bowel disease such as Crohn's disease, Ulcerative Colitis, and colorectal malignancies planning to undergo surgery
  -  Females have English as a primary language
  Exclusion Criteria:
  -  Subjects less than 18 years of age
  -  Subjects unable to give informed consent or complete the validated questionnaires

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: Observational Retrospective Trial on Sequential Hormonal Therapy in Patients With Prostate Cancer

Summary: Observational Retrospective trial on sequential hormonal therapy in patients with Prostate Cancer


Eligibility: Inclusion Criteria:
  -  non metastatic Prostate Cancer
  -  previous treatment with bicalutamide 150mg
  -  biochemical relapse/progression
  Exclusion Criteria:
  -  use of other treatments for 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: Effect of Dutasteride on Androgen-Response Gene Expression in Patients With Advanced Prostate Cancer

Summary: The purpose of this study is to determine if the drug dutasteride increases expression of genes that slow the growth of prostate cancer during treatment with intermittent androgen ablation therapy (hormone therapy).

Detailed description: We have shown in a murine model of treatment with intermittent androgen ablation therapy of prostate cancer that when dutasteride is given during the regrowth phase (off-phase) of intermittent therapy, that tumor growth is inhibited and that survival is improved. We have also shown that testosterone is a more potent inducer of certain tumor suppressor androgen response genes than dihydrotestosterone. In this murine model, we showed that use of a 5-alpha reductase inhibitor (dutasteride) resulted in significant hyperinduction of the U19 tumor suppressor androgen response gene during the regrowth phase of treatment. In the current clinical trial, we will determine if use of dutasteride in men with advanced prostate cancer during the off-phase of intermittent androgen ablation therapy will also result in hyperinduction of these tumor suppressor androgen response genes. Gene expression will be measured in tumor tissue obtained by prostate biopsies during the off-phase when the testosterone level has normalized. PSA levels will also be measured to determine the PSA doubling time during the off-phase to determine the effect of dutasteride on PSA kinetics.

Eligibility: Inclusion Criteria:
  -  Histologically proven prostate cancer
  -  Patients are hormone-naive
  -  Patients either to begin androgen ablation therapy with LHRH agonist or already receiving therapy with LHRH agonist
  -  Advanced prostate cancer with either positive pelvic nodes or bone/visceral metastasis
  -  Must have an intact prostate (no previous surgery or XRT)
  -  ECOG performance status 0-2
  -  Recovery from any major infection or surgical procedure
  -  Signed informed consent
  Exclusion Criteria:
  -  Known intolerance or allergy to dutasteride
  -  Concomitant chemotherapy, biologic therapy, or XRT to prostate
  -  Bilateral orchiectomy
  -  Prior malignancy within 5 years of registration

Relevance to patient case: not relevant