{"protocolSection":{"identificationModule":{"nctId":"NCT02217709","orgStudyIdInfo":{"id":"4P-14-1"},"secondaryIdInfos":[{"id":"NCI-2014-01791","type":"REGISTRY","domain":"CTRP (Clinical Trial Reporting Program)"},{"id":"HS-14-00331"},{"id":"4P-14-1","type":"OTHER","domain":"USC Norris Comprehensive Cancer Center"},{"id":"P30CA014089","type":"NIH","link":"https://reporter.nih.gov/quickSearch/P30CA014089"}],"organization":{"fullName":"University of Southern California","class":"OTHER"},"briefTitle":"Phenelzine Sulfate in Treating Patients With Non-metastatic Recurrent Prostate Cancer","officialTitle":"Phase 2 Trial of Phenelzine in Non-metastatic Recurrent Prostate Cancer"},"statusModule":{"statusVerifiedDate":"2025-11","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2014-09-08","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2020-06-29","type":"ACTUAL"},"completionDateStruct":{"date":"2020-06-29","type":"ACTUAL"},"studyFirstSubmitDate":"2014-08-13","studyFirstSubmitQcDate":"2014-08-14","studyFirstPostDateStruct":{"date":"2014-08-15","type":"ESTIMATED"},"resultsFirstSubmitDate":"2025-10-03","resultsFirstSubmitQcDate":"2026-05-28","resultsFirstPostDateStruct":{"date":"2026-06-25","type":"ACTUAL"},"lastUpdateSubmitDate":"2026-05-28","lastUpdatePostDateStruct":{"date":"2026-06-25","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"University of Southern California","class":"OTHER"},"collaborators":[{"name":"National Cancer Institute (NCI)","class":"NIH"}]},"oversightModule":{"oversightHasDmc":true,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"This phase II trial studies phenelzine sulfate in treating patients with prostate cancer that has not spread to other parts of the body and has come back. Phenelzine sulfate is a type of antidepressant that works by decreasing the amount of a protein called monoamine oxidase (MAO). MAO drugs may have an anticancer effect in prostate cancer.","detailedDescription":"PRIMARY OBJECTIVES:\n\nI. To assess the proportion of patients with biochemical recurrent prostate cancer (BCR-PC) treated with phenelzine (phenelzine sulfate) who achieve a prostate-specific antigen (PSA) decline of \\>= 50% from baseline.\n\nSECONDARY OBJECTIVES:\n\nI. To monitor potential toxicities and/or beneficial effects on quality of life of phenelzine in prostate cancer patients.\n\nII. To assess time to radiographic disease progression for patients with recurrent prostate cancer treated with phenelzine.\n\nEXPLORATIORY OBJECTIVES:\n\nI. To collect blood and other samples to study the relationship between MAO activity, biomarkers and prostate cancer.\n\nOUTLINE:\n\nPatients receive phenelzine sulfate 30 mg by mouth (PO) twice daily (BID) (starting dose of 15 mg daily escalated to 30 mg BID over 16 plus or minus 5 days). Patients who have been treated at 30 mg BID for over 3 cycles with resolution of any and all toxicities to grade \\< or = 1 may increase the dose to a maximum of 45 mg BID at the discretion of the treating investigator. Treatment may continue in the absence of disease progression or unacceptable toxicity.\n\nAfter completion of study treatment, patients are followed up every 3 months for up to 3 years."},"conditionsModule":{"conditions":["Adenocarcinoma of the Prostate","Recurrent Prostate Cancer","Stage I Prostate Cancer","Stage IIA Prostate Cancer","Stage IIB Prostate Cancer","Stage III Prostate Cancer"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE2"],"designInfo":{"allocation":"NA","interventionModel":"SINGLE_GROUP","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":26,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Treatment (phenelzine sulfate)","type":"EXPERIMENTAL","description":"Patients receive phenelzine sulfate 30 mg by mouth (PO) twice daily (BID) (starting dose of 15 mg daily escalated to 30 mg BID over 16 plus or minus 5 days). Patients who have been treated at 30 mg BID for over 3 cycles with resolution of any and all toxicities to grade \\< or = 1 may increase the dose to a maximum of 45 mg BID at the discretion of the treating investigator. Treatment may continue in the absence of disease progression or unacceptable toxicity.","interventionNames":["Drug: phenelzine sulfate","Other: laboratory biomarker analysis","Other: questionnaire administration"]}],"interventions":[{"type":"DRUG","name":"phenelzine sulfate","description":"Given by mouth","armGroupLabels":["Treatment (phenelzine sulfate)"],"otherNames":["Nardil"]},{"type":"OTHER","name":"laboratory biomarker analysis","description":"Correlative studies","armGroupLabels":["Treatment (phenelzine sulfate)"]},{"type":"OTHER","name":"questionnaire administration","description":"Ancillary studies","armGroupLabels":["Treatment (phenelzine sulfate)"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Number of Patients With PSA Decline of >= 50% From Baseline Following at Least 12 Weeks of Treatment With Phenelzine Sulfate","description":"A \\>= 50% decline in prostate-specific antigen (PSA) from baseline is a significant indicator of a positive treatment response in prostate cancer, associated with a lower risk of disease progression and improved survival.","timeFrame":"Baseline to up to 12 months"},{"measure":"Number of Patients With PSA Decline of >= 30% From Baseline Following at Least 12 Weeks of Treatment With Phenelzine Sulfate","description":"A PSA decline of \\>=30% or more from the baseline is a strong predictor of a positive clinical outcome for many types of cancer, especially for advanced prostate cancer. Patients with this level of PSA reduction typically have longer overall survival and a delayed time to disease progression compared to those who do not experience this decline.","timeFrame":"Baseline to up to 12 months"}],"secondaryOutcomes":[{"measure":"Percent of Common Toxicities Observed","description":"Analyses of safety/ toxicity will be performed for all patients having received at least one dose of study drug. The study will use the CTCAE version 4 for reporting of hematologic and non-hematologic adverse events.","timeFrame":"Through 30 days after the last dose of study drug, up to 3 years"},{"measure":"Time to Radiographic Disease Progression for Patients With Recurrent Prostate Cancer Treated With Phenelzine.","timeFrame":"Through study completion, up to 3 years."}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Histologically confirmed adenocarcinoma of the prostate\n* Recurrent prostate cancer following primary therapy as defined by:\n\n  * Post-radical prostatectomy: Any PSA \\>= 0.4 ng/ml\n  * Post-primary radiotherapy: PSA \\>= 2 ng/ml above a post-radiotherapy nadir\n  * Post-primary androgen-deprivation therapy: A confirmed rise of PSA \\>= 2 ng/ml above a post-therapy nadir\n* For patients with non-castrate levels of circulating androgen levels (testosterone \\>= 50 g/dl)\n\n  * PSA levels should be increasing on at least two occasions \\>= 1 week apart\n  * Patients should not be considered candidates for radiation therapy\n* For patients with castrate levels of circulating androgen levels (testosterone \\< 50 ng/dl):\n\n  * PSA levels must be \\>= 0.4 ng/ml (if history of radical prostatectomy) or \\>= 2 ng/ml (if history of non-surgical primary treatment) and found to be increasing on at least two occasions \\>= 1 week apart\n* At least 4 weeks must have elapsed since any changes to hormonal therapy, including at least 4 weeks since flutamide and at least 6 weeks since bicalutamide, nilutamide, or enzalutamide\n* No evidence of metastatic cancer on imaging including a bone scan and computed tomography (CT) scan of chest/abdomen/pelvis\n* Able to understand and adhere to dietary and medication restrictions as recommended for the safe use of phenelzine\n* Men with child bearing potential are required to use an effective means of contraception\n* Leukocytes \\>= 3,000/mcL\n* Absolute neutrophil count \\>= 1,500/mcL\n* Platelets \\>= 100,000/mcL\n* Total bilirubin =\\< 1.5 x upper limit of normal (ULN) except in cases of benign isolated hyperbilirubinemia such as Gilbert's syndrome.\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SPGT\\]) =\\< 2.5 x ULN\n* Creatinine =\\< 1.5 x ULN\n\nExclusion Criteria:\n\n* Uncontrolled hypertension despite appropriate medical therapy (blood pressure \\[BP\\] greater than 160 mmHg systolic and 90 mmHg diastolic at 2 separate measurements no more than 60 minutes apart during the screening visit); Note: patients may be rescreened after adjustment of antihypertensive medications\n* Known prior history of mania or major psychiatric illness (schizophrenia, bipolar disorder, severe major depression requiring hospitalization, etc.)\n* Concurrent use of medications contra-indicated due to potential interactions with phenelzine\n* Inability to comply with dietary restrictions for foods, supplements, and medications with potential for adverse interactions with phenelzine or to otherwise cooperate fully with the investigator and study personnel\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to phenelzine or other monoamine oxidase inhibitors\n* Patients may not be receiving any other investigational agents\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements","healthyVolunteers":false,"sex":"MALE","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Mitchell Gross, MD","affiliation":"University of Southern California","role":"PRINCIPAL_INVESTIGATOR"},{"name":"Jean C. Shih, PhD","affiliation":"University of Southern California","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"USC Norris Westside Cancer Center","city":"Beverly Hills","state":"California","zip":"90211","country":"United States","geoPoint":{"lat":34.07362,"lon":-118.40036}},{"facility":"Los Angeles County-USC Medical Center","city":"Los Angeles","state":"California","zip":"90033","country":"United States","geoPoint":{"lat":34.05223,"lon":-118.24368}},{"facility":"USC Norris Comprehensive Cancer Center","city":"Los Angeles","state":"California","zip":"90033","country":"United States","geoPoint":{"lat":34.05223,"lon":-118.24368}},{"facility":"Keck Medical Center of USC Pasadena","city":"Pasadena","state":"California","zip":"91105","country":"United States","geoPoint":{"lat":34.14778,"lon":-118.14452}}]},"referencesModule":{"references":[{"pmid":"40932155","type":"DERIVED","citation":"Steib A, Pohoczky K, Toth N, Kormos V, Kun J, Kalai T, Mangel L, Matyus P, Helyes Z. The MAO-B Inhibitor Selegiline Reduces the Viability of Different Prostate Cancer Cell Lines and Enhances the Effects of Anti-Androgen and Cytostatic Agents. Pharmacol Res Perspect. 2025 Oct;13(5):e70173. doi: 10.1002/prp2.70173."}]}},"resultsSection":{"participantFlowModule":{"recruitmentDetails":"Recruitment for this study opened in September 2014 and closed in April 2019. All subjects were seen and treated in the medical clinics at the University of Southern California, Los Angeles General Medical Center, and Westside Prostate Cancer Center.","groups":[{"id":"FG000","title":"Treatment (Phenelzine Sulfate)","description":"Patients receive phenelzine sulfate 30 mg by mouth (PO) twice daily (BID) (starting dose of 15 mg daily escalated to 30 mg BID over 16 plus or minus 5 days). Patients who have been treated at 30 mg BID for over 3 cycles with resolution of any and all toxicities to grade \\< or = 1 may increase the dose to a maximum of 45 mg BID at the discretion of the treating investigator. Treatment may continue in the absence of disease progression or unacceptable toxicity.\n\nphenelzine sulfate: Given by mouth\n\nlaboratory biomarker analysis: Correlative studies\n\nquestionnaire administration: Ancillary studies"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"26"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"20"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"6"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"1"}]},{"type":"Physician Decision","reasons":[{"groupId":"FG000","numSubjects":"1"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"4"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Treatment (Phenelzine Sulfate)","description":"Patients receive phenelzine sulfate 30 mg by mouth (PO) twice daily (BID) (starting dose of 15 mg daily escalated to 30 mg BID over 16 plus or minus 5 days). Patients who have been treated at 30 mg BID for over 3 cycles with resolution of any and all toxicities to grade \\< or = 1 may increase the dose to a maximum of 45 mg BID at the discretion of the treating investigator. Treatment may continue in the absence of disease progression or unacceptable toxicity.\n\nphenelzine sulfate: Given by mouth\n\nlaboratory biomarker analysis: Correlative studies\n\nquestionnaire administration: Ancillary studies"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"26"}]}],"measures":[{"title":"Age, Categorical","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"<=18 years","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Between 18 and 65 years","measurements":[{"groupId":"BG000","value":"8"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"18"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"26"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"2"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"24"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"1"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"25"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"26"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Number of Patients With PSA Decline of >= 50% From Baseline Following at Least 12 Weeks of Treatment With Phenelzine Sulfate","description":"A \\>= 50% decline in prostate-specific antigen (PSA) from baseline is a significant indicator of a positive treatment response in prostate cancer, associated with a lower risk of disease progression and improved survival.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Baseline to up to 12 months","groups":[{"id":"OG000","title":"Treatment (Phenelzine Sulfate)","description":"Patients receive phenelzine sulfate 30 mg by mouth (PO) twice daily (BID) (starting dose of 15 mg daily escalated to 30 mg BID over 16 plus or minus 5 days). Patients who have been treated at 30 mg BID for over 3 cycles with resolution of any and all toxicities to grade \\< or = 1 may increase the dose to a maximum of 45 mg BID at the discretion of the treating investigator. Treatment may continue in the absence of disease progression or unacceptable toxicity.\n\nphenelzine sulfate: Given by mouth\n\nlaboratory biomarker analysis: Correlative studies\n\nquestionnaire administration: Ancillary studies"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"20"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}]}]},{"type":"PRIMARY","title":"Number of Patients With PSA Decline of >= 30% From Baseline Following at Least 12 Weeks of Treatment With Phenelzine Sulfate","description":"A PSA decline of \\>=30% or more from the baseline is a strong predictor of a positive clinical outcome for many types of cancer, especially for advanced prostate cancer. Patients with this level of PSA reduction typically have longer overall survival and a delayed time to disease progression compared to those who do not experience this decline.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Baseline to up to 12 months","groups":[{"id":"OG000","title":"Treatment (Phenelzine Sulfate)","description":"Patients receive phenelzine sulfate 30 mg by mouth (PO) twice daily (BID) (starting dose of 15 mg daily escalated to 30 mg BID over 16 plus or minus 5 days). Patients who have been treated at 30 mg BID for over 3 cycles with resolution of any and all toxicities to grade \\< or = 1 may increase the dose to a maximum of 45 mg BID at the discretion of the treating investigator. Treatment may continue in the absence of disease progression or unacceptable toxicity.\n\nphenelzine sulfate: Given by mouth\n\nlaboratory biomarker analysis: Correlative studies\n\nquestionnaire administration: Ancillary studies"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"20"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"4"}]}]}]},{"type":"SECONDARY","title":"Percent of Common Toxicities Observed","description":"Analyses of safety/ toxicity will be performed for all patients having received at least one dose of study drug. The study will use the CTCAE version 4 for reporting of hematologic and non-hematologic adverse events.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Through 30 days after the last dose of study drug, up to 3 years","groups":[{"id":"OG000","title":"Treatment (Phenelzine Sulfate)","description":"Patients receive phenelzine sulfate 30 mg by mouth (PO) twice daily (BID) (starting dose of 15 mg daily escalated to 30 mg BID over 16 plus or minus 5 days). Patients who have been treated at 30 mg BID for over 3 cycles with resolution of any and all toxicities to grade \\< or = 1 may increase the dose to a maximum of 45 mg BID at the discretion of the treating investigator. Treatment may continue in the absence of disease progression or unacceptable toxicity.\n\nphenelzine sulfate: Given by mouth\n\nlaboratory biomarker analysis: Correlative studies\n\nquestionnaire administration: Ancillary studies"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"20"}]}],"classes":[{"title":"dizziness, grade 1","categories":[{"measurements":[{"groupId":"OG000","value":"45"}]}]},{"title":"dizziness, grade 2","categories":[{"measurements":[{"groupId":"OG000","value":"35"}]}]},{"title":"hypertension, grade ≥ 2","categories":[{"measurements":[{"groupId":"OG000","value":"30"}]}]},{"title":"edema, grade 1","categories":[{"measurements":[{"groupId":"OG000","value":"25"}]}]},{"title":"edema, grade 2","categories":[{"measurements":[{"groupId":"OG000","value":"10"}]}]}]},{"type":"SECONDARY","title":"Time to Radiographic Disease Progression for Patients With Recurrent Prostate Cancer Treated With Phenelzine.","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"Months","timeFrame":"Through study completion, up to 3 years.","groups":[{"id":"OG000","title":"Treatment (Phenelzine Sulfate)","description":"Patients receive phenelzine sulfate 30 mg by mouth (PO) twice daily (BID) (starting dose of 15 mg daily escalated to 30 mg BID over 16 plus or minus 5 days). Patients who have been treated at 30 mg BID for over 3 cycles with resolution of any and all toxicities to grade \\< or = 1 may increase the dose to a maximum of 45 mg BID at the discretion of the treating investigator. Treatment may continue in the absence of disease progression or unacceptable toxicity.\n\nphenelzine sulfate: Given by mouth\n\nlaboratory biomarker analysis: Correlative studies\n\nquestionnaire administration: Ancillary studies"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"20"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"NA","lowerLimit":"NA","upperLimit":"NA","comment":"We used Kaplan Meier method to estimate the probability time to progression. Median of time to progression is the time point when 50% of the subjects experienced progression. If we observe less than 50% of subjects experienced progression, we will say the median of survival or time to progression or treatment failure is not reached."}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"0","timeFrame":"Through 30 days after final dose of study drug, up to 3 years.","eventGroups":[{"id":"EG000","title":"Treatment (Phenelzine Sulfate)","description":"Patients receive phenelzine sulfate 30 mg by mouth (PO) twice daily (BID) (starting dose of 15 mg daily escalated to 30 mg BID over 16 plus or minus 5 days). Patients who have been treated at 30 mg BID for over 3 cycles with resolution of any and all toxicities to grade \\< or = 1 may increase the dose to a maximum of 45 mg BID at the discretion of the treating investigator. Treatment may continue in the absence of disease progression or unacceptable toxicity.\n\nphenelzine sulfate: Given by mouth\n\nlaboratory biomarker analysis: Correlative studies\n\nquestionnaire administration: Ancillary studies","deathsNumAffected":1,"deathsNumAtRisk":26,"seriousNumAffected":8,"seriousNumAtRisk":26,"otherNumAffected":26,"otherNumAtRisk":26}],"seriousEvents":[{"term":"Constipation","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":26}]},{"term":"Diarrhea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":26}]},{"term":"Weight gain","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":26}]},{"term":"Syncope","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":26}]},{"term":"Hypertension","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (4.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":26}]},{"term":"Hypotension","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (4.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":26}]}],"otherEvents":[{"term":"Blurred Vision","organSystem":"Eye disorders","sourceVocabulary":"CTCAE (4.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":26}]},{"term":"Constipation","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":26}]},{"term":"Diarrhea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":26}]},{"term":"Dry mouth","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":26}]},{"term":"Nausea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":26}]},{"term":"Stomach pain","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":26}]},{"term":"Edema limbs","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":26}]},{"term":"Fatigue","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":26}]},{"term":"Alanine aminotransferase increased","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":26}]},{"term":"Aspartate aminotransferase increased","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":26}]},{"term":"Weight gain","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":26}]},{"term":"Dizziness","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":26}]},{"term":"Headache","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":26}]},{"term":"Memory impairment","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":26}]},{"term":"Movements involuntary","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":26}]},{"term":"Somnolence","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":26}]},{"term":"Tremor","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":26}]},{"term":"Agitation","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (4.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":26}]},{"term":"Anorgasmia","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (4.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":26}]},{"term":"Anxiety","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (4.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":26}]},{"term":"Confusion","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (4.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":26}]},{"term":"Depression","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (4.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":26}]},{"term":"Insomnia","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (4.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":26}]},{"term":"Hypertension","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (4.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":26}]},{"term":"Hypotension","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (4.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":26}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":true},"pointOfContact":{"title":"Tali Homsey","organization":"USC/Norris Comprehensive Cancer Center","email":"tali.homsey@med.usc.edu","phone":"(323) 865-0451"}}},"documentSection":{"largeDocumentModule":{"largeDocs":[{"typeAbbrev":"Prot_SAP","hasProtocol":true,"hasSap":true,"hasIcf":false,"label":"Study Protocol and Statistical Analysis Plan","date":"2016-01-07","uploadDate":"2025-10-03T16:05","filename":"Prot_SAP_000.pdf","size":902918}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D011471","term":"Prostatic Neoplasms"}],"ancestors":[{"id":"D005834","term":"Genital Neoplasms, Male"},{"id":"D014565","term":"Urogenital Neoplasms"},{"id":"D009371","term":"Neoplasms by Site"},{"id":"D009369","term":"Neoplasms"},{"id":"D005832","term":"Genital Diseases, Male"},{"id":"D000091662","term":"Genital Diseases"},{"id":"D000091642","term":"Urogenital Diseases"},{"id":"D011469","term":"Prostatic Diseases"},{"id":"D052801","term":"Male Urogenital Diseases"}]},"interventionBrowseModule":{"meshes":[{"id":"D010624","term":"Phenelzine"}],"ancestors":[{"id":"D006834","term":"Hydrazines"},{"id":"D009930","term":"Organic Chemicals"}]}},"hasResults":true}