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The goal of this study is to investigate the feasibility and toxicity of using prostate-specific membrane antigen-positron emission tomography (PSMA-PET) and multi-parametric magnetic resonance imagining (mpMRI) with PET-MR technology to define radiotherapy targets, while meeting all the current planning criteria.
PSMA-PET is highly sensitive and specific for detecting prostate cancer. PSMA-PET and mpMRI can potentially help guide target volumes for patients with unfavorable-risk prostate cancer receiving radiation by designing a radiation treatment plan so that the entire prostate receives the prescribed dose of radiation in addition to the visible tumor in the prostate as detected by mpMRI and/or PSMA-PET receiving any inevitable intrinsic plan "hot spots" or areas of dose above the prescription.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PMSA-PET/MRI | Experimental | Patients scheduled to receive PMSA-PET/MRI scan in addition to standard of care CT scan prior to treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 68Ga-HBED-CC-PSMA | Drug | Radioactive tracer used during imaging to help detect PSMA expressing tumor cells. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Early Genitourinary and Gastrointestinal Toxicity | Grade 3 or higher early genitourinary and gastrointestinal toxicities, defined by CTCAE version 5.0, include adverse events that develop within three months after starting radiation therapy. The NCI Common Terminology Criteria for Adverse Events is a descriptive terminology which can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE. | Up to 22 weeks (3 months after completion of radiation therapy) |
| Measure | Description | Time Frame |
|---|---|---|
| Late Genitourinary Toxicity After Radiation | Grade 3 or higher late genitourinary and gastrointestinal toxicities, defined by CTCAE version 5.0, include adverse events that develop three months after starting radiation therapy. The NCI Common Terminology Criteria for Adverse Events is a descriptive terminology which can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 Life-threatening consequence |
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Inclusion Criteria:
Exclusion Criteria:
Contraindications for MRI
Other prior or concomitant malignancies with the exception of:
Inflammatory bowel disease
Absolute contraindications to brachytherapy per American Brachytherapy Society: unacceptable operative risk, absence of rectum, large TURP defects
Male participants only as this is a prostate cancer study
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| Name | Affiliation | Role |
|---|---|---|
| Michael Repka, MD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
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| Label | URL |
|---|---|
| UNC Lineberger Comprehensive Cancer Center | View source |
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Eight subjects were screened, enrolled, and started treatment at one center in the United States between 7/16/2020 and 2/7/2024.
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| ID | Title | Description |
|---|---|---|
| FG000 | PMSA-PET/MRI | Patients scheduled to receive PMSA-PET/MRI scan in addition to standard of care CT scan prior to treatment 68Ga-HBED-CC-PSMA: Radioactive tracer used during imaging to help detect PSMA expressing tumor cells. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All participants who started to study treatment were included.
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| ID | Title | Description |
|---|---|---|
| BG000 | PMSA-PET/MRI | Patients scheduled to receive PMSA-PET/MRI scan in addition to standard of care CT scan prior to treatment 68Ga-HBED-CC-PSMA: Radioactive tracer used during imaging to help detect PSMA expressing tumor cells. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Early Genitourinary and Gastrointestinal Toxicity | Grade 3 or higher early genitourinary and gastrointestinal toxicities, defined by CTCAE version 5.0, include adverse events that develop within three months after starting radiation therapy. The NCI Common Terminology Criteria for Adverse Events is a descriptive terminology which can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE. | Participants started study treatment | Posted | Count of Participants | Participants | Up to 22 weeks (3 months after completion of radiation therapy) |
|
Up to 49 months.
Adverse events were collected from day one of the study treatment to 49 months after completion of treatment. Any hospital admission was graded as a serious adverse event per protocol.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PMSA-PET/MRI | Patients scheduled to receive PMSA-PET/MRI scan in addition to standard of care CT scan prior to treatment 68Ga-HBED-CC-PSMA: Radioactive tracer used during imaging to help detect PSMA expressing tumor cells. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Proctitis | Gastrointestinal disorders | CTCAE v5 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | CTCAE v5 | Non-systematic Assessment |
This study was terminated before reaching target accrual and follow-up was suspended. Additionally, two versions of the protocol were uploaded since no new participant started to study after amendment.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Melahat Canter | UNC Lineberger Comprehensive Cancer Center | 919-966-4432 | Melahat_Canter@med.unc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 24, 2024 | Feb 5, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000718244 | gallium 68 PSMA-11 |
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| Three months after starting radiation therapy to up to 48 months post-treatment |
| Biochemical Control Using Prostate-Specific Antigen (PSA) Levels | Biochemical control will be defined according to the Phoenix criteria (PSA rise of <2 ng/mL over nadir). Number of subjects | At 2 years after radiation therapy |
| Patient-reported Quality of Life Using Prostate Cancer Symptom Indices (PCSI) Rectal Domain | Patient-reported quality of life in men with prostate cancer can be assessed using the Prostate Cancer Symptom Indices (PCSI), a validated instrument designed to measure disease-specific symptoms and their impact on daily functioning. The PCSI evaluates multiple domains, including urinary function, bowel function, sexual function, and overall well-being. Each domain contains a set of symptom-specific questions rated on a Likert-type scale, typically ranging from 0 (no symptoms or no problem) to 4 or 5 (severe symptoms or major problem). Domain scores were calculated by summing item responses and converting them to a 0-100 scale, where higher scores indicate greater symptom burden. | At 1, 3, 6, 9, 12, 18, 24, 30, 36, 42 months post radiotherapy |
| Patient-reported Quality of Life Using Prostate Cancer Symptom Indices (PCSI) - Urinary Domain | Patient-reported quality of life in men with prostate cancer can be assessed using the Prostate Cancer Symptom Indices (PCSI), a validated instrument designed to measure disease-specific symptoms and their impact on daily functioning. The PCSI evaluates multiple domains, including urinary function, bowel function, sexual function, and overall well-being. Each domain contains a set of symptom-specific questions rated on a Likert-type scale, typically ranging from 0 (no symptoms or no problem) to 4 or 5 (severe symptoms or major problem). Domain scores were calculated by summing item responses and converting them to a 0-100 scale, where higher scores indicate greater symptom burden. | At 1, 3, 6, 9, 12, 18, 24, 30, 36, 42 months post radiotherapy |
| Patient-reported Quality of Life Using the Expanded Prostate Cancer Index Composite (EPIC-26) Bowel Domain | The Expanded Prostate Cancer Index Composite-26 (EPIC-26) is a validated, patient-reported questionnaire designed to assess health-related quality of life among men with prostate cancer. It is a shortened version of the original 50-item EPIC instrument and focuses on five key domains: urinary incontinence, urinary irritation/obstruction, bowel function, sexual function, and hormonal function. EPIC-26 bowel domain reflects symptoms such as bowel urgency, frequency, pain, and overall bowel function. Patients rate each item on a 1-5 scale, and responses are converted to a 0-100 score, with higher scores indicating better bowel function and fewer symptoms. This domain provides a focused measure of how prostate cancer and its treatments affect daily bowel-related quality of life. | At 1, 3, 6, 9, 12, 18, 24, 30, 36, 42 months post radiotherapy |
| Patient-reported Quality of Life Using the Expanded Prostate Cancer Index Composite (EPIC-26) Hormonal Function Domain | The Expanded Prostate Cancer Index Composite-26 (EPIC-26) is a validated, patient-reported questionnaire designed to assess health-related quality of life among men with prostate cancer. It is a shortened version of the original 50-item EPIC instrument and focuses on five key domains: urinary incontinence, urinary irritation/obstruction, bowel function, sexual function, and hormonal function. EPIC-26 hormonal function domain captures symptoms such as fatigue, hot flashes, breast tenderness, and emotional changes. Items are rated on a 1-5 scale and converted to a 0-100 score, with higher scores indicating better hormonal function and fewer symptoms. This domain provides a focused assessment of how prostate cancer and its treatments affect patients' hormone-related quality of life. | At 1, 3, 6, 9, 12, 18, 24, 30, 36, 42 months post radiotherapy |
| Patient-reported Quality of Life Using the Expanded Prostate Cancer Index Composite (EPIC-26) -Sexual Function Domain | The Expanded Prostate Cancer Index Composite-26 (EPIC-26) is a validated, patient-reported questionnaire designed to assess health-related quality of life among men with prostate cancer. It is a shortened version of the original 50-item EPIC instrument and focuses on five key domains: urinary incontinence, urinary irritation/obstruction, bowel function, sexual function, and hormonal function. EPIC-26 sexual function domain assesses erectile function, ability to achieve orgasm, sexual desire, and overall sexual satisfaction. Items are rated on a 1-5 scale and converted to a 0-100 score, with higher scores reflecting better sexual function and fewer difficulties. This domain provides a focused measure of how prostate cancer and its treatments impact sexual health and related quality of life. | Baseline and at 1, 3, 6, 9, 12, 18, 24, 30, 36, 42 months post radiotherapy |
| Patient-reported Quality of Life Using the Expanded Prostate Cancer Index Composite (EPIC-26) Urinary Incontinence, Urinary Irritation Domains | The Expanded Prostate Cancer Index Composite-26 (EPIC-26) is a validated, patient-reported questionnaire designed to assess health-related quality of life among men with prostate cancer. It is a shortened version of the original 50-item EPIC instrument and focuses on five key domains: urinary incontinence, urinary irritation/obstruction, bowel function, sexual function, and hormonal function. EPIC-26 urinary incontinence and urinary irritation/obstruction domains reflects issues such as urine leakage, pad use, urgency, frequency, and weak stream. Items are rated on a 1-5 scale and converted to 0-100 scores, with higher values indicating better urinary function and fewer symptoms. Together, these domains provide a detailed view of how prostate cancer and its treatments affect daily urinary health. | at 1, 3, 6, 9, 12, 18, 24, 30, 36, 42 months post radiotherapy |
| The Number of Participants Started Study. | The number of participants started study. | Baseline |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG000 | PMSA-PET/MRI | Patients scheduled to receive PMSA-PET/MRI scan in addition to standard of care CT scan prior to treatment 68Ga-HBED-CC-PSMA: Radioactive tracer used during imaging to help detect PSMA expressing tumor cells. |
|
|
| Secondary | Late Genitourinary Toxicity After Radiation | Grade 3 or higher late genitourinary and gastrointestinal toxicities, defined by CTCAE version 5.0, include adverse events that develop three months after starting radiation therapy. The NCI Common Terminology Criteria for Adverse Events is a descriptive terminology which can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 Life-threatening consequence | Participants who started study treatment | Posted | Count of Participants | Participants | Three months after starting radiation therapy to up to 48 months post-treatment |
|
|
|
| Secondary | Biochemical Control Using Prostate-Specific Antigen (PSA) Levels | Biochemical control will be defined according to the Phoenix criteria (PSA rise of <2 ng/mL over nadir). Number of subjects | We have data available for only 4 subjects at 2 years because of subjects withdrawn, and we do not have 5 years follow-up data for any subjects due to study was terminated by sponsor. | Posted | Count of Participants | Participants | At 2 years after radiation therapy |
|
|
|
| Secondary | Patient-reported Quality of Life Using Prostate Cancer Symptom Indices (PCSI) Rectal Domain | Patient-reported quality of life in men with prostate cancer can be assessed using the Prostate Cancer Symptom Indices (PCSI), a validated instrument designed to measure disease-specific symptoms and their impact on daily functioning. The PCSI evaluates multiple domains, including urinary function, bowel function, sexual function, and overall well-being. Each domain contains a set of symptom-specific questions rated on a Likert-type scale, typically ranging from 0 (no symptoms or no problem) to 4 or 5 (severe symptoms or major problem). Domain scores were calculated by summing item responses and converting them to a 0-100 scale, where higher scores indicate greater symptom burden. | Participants started to study intervention. | Posted | Mean | Standard Deviation | score on a scale | At 1, 3, 6, 9, 12, 18, 24, 30, 36, 42 months post radiotherapy |
|
|
|
| Secondary | Patient-reported Quality of Life Using Prostate Cancer Symptom Indices (PCSI) - Urinary Domain | Patient-reported quality of life in men with prostate cancer can be assessed using the Prostate Cancer Symptom Indices (PCSI), a validated instrument designed to measure disease-specific symptoms and their impact on daily functioning. The PCSI evaluates multiple domains, including urinary function, bowel function, sexual function, and overall well-being. Each domain contains a set of symptom-specific questions rated on a Likert-type scale, typically ranging from 0 (no symptoms or no problem) to 4 or 5 (severe symptoms or major problem). Domain scores were calculated by summing item responses and converting them to a 0-100 scale, where higher scores indicate greater symptom burden. | Participants started to study intervention. | Posted | Mean | Standard Deviation | score on a scale | At 1, 3, 6, 9, 12, 18, 24, 30, 36, 42 months post radiotherapy |
|
|
|
| Secondary | Patient-reported Quality of Life Using the Expanded Prostate Cancer Index Composite (EPIC-26) Bowel Domain | The Expanded Prostate Cancer Index Composite-26 (EPIC-26) is a validated, patient-reported questionnaire designed to assess health-related quality of life among men with prostate cancer. It is a shortened version of the original 50-item EPIC instrument and focuses on five key domains: urinary incontinence, urinary irritation/obstruction, bowel function, sexual function, and hormonal function. EPIC-26 bowel domain reflects symptoms such as bowel urgency, frequency, pain, and overall bowel function. Patients rate each item on a 1-5 scale, and responses are converted to a 0-100 score, with higher scores indicating better bowel function and fewer symptoms. This domain provides a focused measure of how prostate cancer and its treatments affect daily bowel-related quality of life. | Participants started to study intervention. | Posted | Mean | Standard Deviation | score on a scale | At 1, 3, 6, 9, 12, 18, 24, 30, 36, 42 months post radiotherapy |
|
|
|
| Secondary | Patient-reported Quality of Life Using the Expanded Prostate Cancer Index Composite (EPIC-26) Hormonal Function Domain | The Expanded Prostate Cancer Index Composite-26 (EPIC-26) is a validated, patient-reported questionnaire designed to assess health-related quality of life among men with prostate cancer. It is a shortened version of the original 50-item EPIC instrument and focuses on five key domains: urinary incontinence, urinary irritation/obstruction, bowel function, sexual function, and hormonal function. EPIC-26 hormonal function domain captures symptoms such as fatigue, hot flashes, breast tenderness, and emotional changes. Items are rated on a 1-5 scale and converted to a 0-100 score, with higher scores indicating better hormonal function and fewer symptoms. This domain provides a focused assessment of how prostate cancer and its treatments affect patients' hormone-related quality of life. | Participants started to study intervention. | Posted | Mean | Standard Deviation | score on a scale | At 1, 3, 6, 9, 12, 18, 24, 30, 36, 42 months post radiotherapy |
|
|
|
| Secondary | Patient-reported Quality of Life Using the Expanded Prostate Cancer Index Composite (EPIC-26) -Sexual Function Domain | The Expanded Prostate Cancer Index Composite-26 (EPIC-26) is a validated, patient-reported questionnaire designed to assess health-related quality of life among men with prostate cancer. It is a shortened version of the original 50-item EPIC instrument and focuses on five key domains: urinary incontinence, urinary irritation/obstruction, bowel function, sexual function, and hormonal function. EPIC-26 sexual function domain assesses erectile function, ability to achieve orgasm, sexual desire, and overall sexual satisfaction. Items are rated on a 1-5 scale and converted to a 0-100 score, with higher scores reflecting better sexual function and fewer difficulties. This domain provides a focused measure of how prostate cancer and its treatments impact sexual health and related quality of life. | Participants started to study intervention. | Posted | Mean | Standard Deviation | score on a scale | Baseline and at 1, 3, 6, 9, 12, 18, 24, 30, 36, 42 months post radiotherapy |
|
|
|
| Secondary | Patient-reported Quality of Life Using the Expanded Prostate Cancer Index Composite (EPIC-26) Urinary Incontinence, Urinary Irritation Domains | The Expanded Prostate Cancer Index Composite-26 (EPIC-26) is a validated, patient-reported questionnaire designed to assess health-related quality of life among men with prostate cancer. It is a shortened version of the original 50-item EPIC instrument and focuses on five key domains: urinary incontinence, urinary irritation/obstruction, bowel function, sexual function, and hormonal function. EPIC-26 urinary incontinence and urinary irritation/obstruction domains reflects issues such as urine leakage, pad use, urgency, frequency, and weak stream. Items are rated on a 1-5 scale and converted to 0-100 scores, with higher values indicating better urinary function and fewer symptoms. Together, these domains provide a detailed view of how prostate cancer and its treatments affect daily urinary health. | Participants started to study intervention. | Posted | Mean | Standard Deviation | score on a scale | at 1, 3, 6, 9, 12, 18, 24, 30, 36, 42 months post radiotherapy |
|
|
|
| Secondary | The Number of Participants Started Study. | The number of participants started study. | Participants who screened for the study treatment. | Posted | Count of Participants | Participants | Baseline |
|
|
|
| 2 |
| 8 |
| 2 |
| 8 |
| 8 |
| 8 |
| Rectal ulcer | Gastrointestinal disorders | CTCAE v5 | Non-systematic Assessment |
|
| Rectal fistula | Gastrointestinal disorders | CTCAE v5 | Non-systematic Assessment |
|
| Kidney infection | Infections and infestations | CTCAE v5 | Non-systematic Assessment |
|
| Acidosis | Metabolism and nutrition disorders | CTCAE v5 | Non-systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE v5 | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE v5 | Non-systematic Assessment |
|
| Proctitis | Gastrointestinal disorders | CTCAE v5 | Non-systematic Assessment |
|
| Rectal pain | Gastrointestinal disorders | CTCAE v5 | Non-systematic Assessment |
|
| Chronic kidney disease | Renal and urinary disorders | CTCAE v5 | Non-systematic Assessment |
|
| Dysuria | Renal and urinary disorders | CTCAE v5 | Non-systematic Assessment |
|
| Urinary frequency | Renal and urinary disorders | CTCAE v5 | Non-systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | CTCAE v5 | Non-systematic Assessment |
|
| Urinary urgency | Renal and urinary disorders | CTCAE v5 | Non-systematic Assessment |
|
| Breast pain | Reproductive system and breast disorders | CTCAE v5 | Non-systematic Assessment |
|
| Scrotal pain | Reproductive system and breast disorders | CTCAE v5 | Non-systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | CTCAE v5 | Non-systematic Assessment |
|
| Chest pain - cardiac | Cardiac disorders | CTCAE v5 | Non-systematic Assessment |
|
| Glaucoma | Eye disorders | CTCAE v5 | Non-systematic Assessment |
|
| Fatigue | General disorders | CTCAE v5 | Non-systematic Assessment |
|
| Weight loss | Investigations | CTCAE v5 | Non-systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE v5 | Non-systematic Assessment |
|
| Hyperlipidemia | Metabolism and nutrition disorders | CTCAE v5 | Non-systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | CTCAE v5 | Non-systematic Assessment |
|
| Hot flashes | Vascular disorders | CTCAE v5 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | CTCAE v5 | Non-systematic Assessment |
|
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| Title | Measurements |
|---|---|
|
| Fecal incontinence |
|
| Kidney infection (Pyelonephritis) |
|
| urinary irritation |
|