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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I: SIMRT | Active Comparator | 'Participants in this group will receive the Standard Fractionated Intensity Modulated Radiotherapy (SIMRT) consisting 40 fractions over 8 weeks. |
|
| Arm II: HTIMRT | Active Comparator | Participants in this group will receive the Hypofractionated Targeted Intensity Modulated Radiotherapy (HTIMRT) consisting of 38 fractions over 7.5 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SIMRT | Radiation | A total dose of 80 Gy will be delivered in 40 fractions to the Clinical Target Volume (CTV). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Biopsy Failure | Number of participants showing positive prostate biopsy finding post treatment. | Up to 2.25 years |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity Rate | Toxicity rate will be reported as the number of participants experiencing any treatment-related adverse events. Acute and Late Toxicity will be evaluated by treating physician using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0. Acute toxicity will be defined as any treatment-related adverse event during and within 3 months of completing treatment. Late Toxicity will be defined as any treatment-related adverse events occurring more than 3 months after treatment completion. |
Not provided
Inclusion Criteria:
A. Biopsy confirmed adenocarcinoma of the prostate.
B. T1-T3a disease based on digital rectal exam.
C. No evidence of metastasis by any clinical criteria or available radiographic tests.
D. Gleason score 6-8.
E. Patients with Gleason score 8 must be offered long term androgen deprivation therapy (ADT) and refuse such treatment because only 4-6 (±2 months) months (short term ADT) is permitted on this protocol. Gleason score ≥ 8 patients should be recommended to receive short term ADT in conjunction with RT. When given, the ADT recommended to begin after fiducial marker placement, if applicable; however, ADT is permitted to have been started up to two months prior to the signing of consent.
F. PSA ≤100 ng/mL within 3 months of enrollment. If PSA was above 100 and dropped to ≤100 with antibiotics, this is acceptable for enrollment.
G. If PSA is >15 ng/ml or there is ≥ Gleason 8 disease, a bone scan should be obtained ≤4 months before enrollment and should be without evidence of metastasis. A questionable bone scan is acceptable if plain x-rays, CT and/or MRI are negative for metastasis.
H. No previous pelvic radiotherapy
I. No previous history of radical/total prostatectomy (suprapubic prostatectomy is acceptable)
J. No concurrent, active malignancy, other than nonmetastatic skin cancer or early stage chronic lymphocytic leukemia (well-differentiated small cell lymphocytic lymphoma). If a prior malignancy is in remission for ≥ 5 years then the patient is eligible.
K. Identifiable multiparameter functional MRI defined tumor lesion or lesions using a 1.5T or 3.0T MRI (3.0T preferable), that total in volume <33% of the prostate within 3 months prior to enrollment.
a. Multiparametric functional including diffusion weighted imaging (DWI) of prostate and pelvis is required prior to protocol consideration
L. Ability to understand and the willingness to sign a written informed consent document
M. Zubrod performance status <2 (Karnofsky or Eastern Cooperative Oncology Group (ECOG) performance status may be used to estimate Zubrod)
N. Willingness to fill out quality of life/psychosocial forms.
O. Age ≥35 and ≤85 years.
P. Serum testosterone is within 40% of normal assay limits (e.g., x=0.4*lower assay limit and x=.04*upper assay limit + upper assay limit),, taken within 4 months of enrollment. Patients who have been started on ADT prior to signing consent are not required to have a serum testosterone at this level prior to signing consent; but, a serum testosterone prior to fiducial marker placement is recommended.
Q. Serum liver function tests (LFTs) taken within 3 months of enrollment.
R. Complete blood counts taken within 3 months of enrollment.
Exclusion Criteria
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Alan Pollack, MD, PhD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Only 9 participants in Arm I and 7 participants in Arm II received study intervention.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Arm I: SIMRT | 'Participants in this group will receive the Standard Fractionated Intensity Modulated Radiotherapy (SIMRT) consisting 40 fractions over 8 weeks. SIMRT: A total dose of 80 Gy will be delivered in 40 fractions to the Clinical Target Volume (CTV). |
| FG001 | Arm II: HTIMRT | All participants in this group will receive the Hypofractionated Targeted Intensity Modulated Radiotherapy (HTIMRT) consisting of a total of 38 fractions over 7.5 weeks. HTIMRT: Dose escalation to the Multiparametric MRI (MP-MRI) by dose painting at 2.35-2.40 Gy per fraction, while the rest of the Clinical Target Volume (CTV) receives 2.0 Gy a fraction to 76 Gy. The hypofractionated targeted (HT) boost region will receive an absolute dose of 89.3-91.2 Gy. Assuming an α/β ratio of 3.0, this would be equivalent to 95.5 Gy in 2.0 Gy fractions. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Enrollment |
|
| |||||||||||||||||||||
| Treatment |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Arm I: SIMRT | 'Participants in this group will receive the Standard Fractionated Intensity Modulated Radiotherapy (SIMRT) consisting 40 fractions over 8 weeks. SIMRT: A total dose of 80 Gy will be delivered in 40 fractions to the Clinical Target Volume (CTV). |
| BG001 | Arm II: HTIMRT |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Number of Participants With Biopsy Failure | Number of participants showing positive prostate biopsy finding post treatment. | Of the 18 enrolled participants, only 16 participants were still enrolled at the 2.25 years follow up. Of the 16 participants, only 9 participants were able to complete the post treatment biopsy. | Posted | Count of Participants | Participants | Up to 2.25 years |
|
Up to 6 years
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm I: SIMRT | 'Participants in this group will receive the Standard Fractionated Intensity Modulated Radiotherapy (SIMRT) consisting 40 fractions over 8 weeks. SIMRT: A total dose of 80 Gy will be delivered in 40 fractions to the Clinical Target Volume (CTV). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute coronary syndrome | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anal hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alan Pollack MD, PhD | University of Miami | 305-243-4916 | apollack@med.miami.edu |
Not provided
| 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 | Mar 30, 2016 | Apr 28, 2021 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| HTIMRT | Radiation | Dose escalation to the Multiparametric MRI (MP-MRI) by dose painting at 2.35-2.40 Gy per fraction, while the rest of the Clinical Target Volume (CTV) receives 2.0 Gy a fraction to 76 Gy. The hypofractionated targeted (HT) boost region will receive an absolute dose of 89.3-91.2 Gy. Assuming an α/β ratio of 3.0, this would be equivalent to 95.5 Gy in 2.0 Gy fractions. |
|
|
| Up to 6 years |
| Mortality | Mortality will be reported as overall survival and failure free survival. Overall survival is defined as the elapsed time from start of radiotherapy to death from any cause. Failure free survival is defined as the elapsed time from start of radiotherapy to first documented evidence of biochemical or clinical failure or death from any cause, whichever occurs first. In the absence of any event defining failure, follow-up time will be censored at the date of last documented failure-free status. | Up to 6 years |
| Failure Rate | Failure rate will be reported as the incidence of biochemical or clinical failure. Biochemical failure is defined is an increase of 2 or greater from nadir of Prostate Specific Antigen (PSA) levels. Clinical Failure is defined as newly identified extension outside the prostate after initial regression, or urinary obstructive symptoms with carcinoma or regional/distant failure due to radiographic evidence metastasis. | Up to 6 years |
| EPIC SF-12 Scores | Health-related Quality of Life (HRQOL) will be measured using the Expanded Prostate Cancer Index Composite and Medical Outcomes Study SF-12 (EPIC SF-12) to evaluate patient function and satisfaction after prostate cancer treatment. Response options for each item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better HRQOL. | At baseline, at last week of treatment (Up to 8 weeks), at 6 weeks after treatment (Up to 14 weeks), at 3 months after treatment (Up to 20 weeks), at 9 months after treatment (Up to 44 weeks). |
| MAX-PC Scores | Health-related quality of life (HRQOL) will be measured using the scores on the Modified 18-item Memorial Anxiety Scale for Prostate Cancer (MAX-PC). The scale consists of 18 items (e.g. "I thought about prostate cancer even though I didn't mean to.") scored on a scale from 0 ("not at all") to 3 ("often"). Total scores range from 0 to 54, with higher scores indicating higher levels of anxiety. | At baseline, at last week of treatment (Up to 8 weeks), at 6 weeks after treatment (Up to 14 weeks), at 3 months after treatment (Up to 20 weeks), at 9 months after treatment (Up to 44 weeks) |
| Biomarker Expression in Prostate Tumor Regions | The amount of biomarker expression will be evaluated via immunohistochemistry (IHC) from ultrasound guided prostate biopsy tissue samples for both functional MRI suspicious regions and those that are not suspicious. | Up to 3 years |
| Incidence of Circulating Free DNA | Incidence of circulating free DNA, as assessed from blood samples. | Up to 3 years |
| NOT COMPLETED |
|
|
Participants in this group will receive the Hypofractionated Targeted Intensity Modulated Radiotherapy (HTIMRT) consisting of 38 fractions over 7.5 weeks. HTIMRT: Dose escalation to the Multiparametric MRI (MP-MRI) by dose painting at 2.35-2.40 Gy per fraction, while the rest of the Clinical Target Volume (CTV) receives 2.0 Gy a fraction to 76 Gy. The hypofractionated targeted (HT) boost region will receive an absolute dose of 89.3-91.2 Gy. Assuming an α/β ratio of 3.0, this would be equivalent to 95.5 Gy in 2.0 Gy fractions. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Participants in this group will receive the Hypofractionated Targeted Intensity Modulated Radiotherapy (HTIMRT) consisting of 38 fractions over 7.5 weeks.
HTIMRT: Dose escalation to the Multiparametric MRI (MP-MRI) by dose painting at 2.35-2.40 Gy per fraction, while the rest of the Clinical Target Volume (CTV) receives 2.0 Gy a fraction to 76 Gy. The hypofractionated targeted (HT) boost region will receive an absolute dose of 89.3-91.2 Gy. Assuming an α/β ratio of 3.0, this would be equivalent to 95.5 Gy in 2.0 Gy fractions.
|
|
| Secondary | Toxicity Rate | Toxicity rate will be reported as the number of participants experiencing any treatment-related adverse events. Acute and Late Toxicity will be evaluated by treating physician using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0. Acute toxicity will be defined as any treatment-related adverse event during and within 3 months of completing treatment. Late Toxicity will be defined as any treatment-related adverse events occurring more than 3 months after treatment completion. | Only 16 participants received study intervention. | Posted | Count of Participants | Participants | Up to 6 years |
|
|
|
| Secondary | Mortality | Mortality will be reported as overall survival and failure free survival. Overall survival is defined as the elapsed time from start of radiotherapy to death from any cause. Failure free survival is defined as the elapsed time from start of radiotherapy to first documented evidence of biochemical or clinical failure or death from any cause, whichever occurs first. In the absence of any event defining failure, follow-up time will be censored at the date of last documented failure-free status. | Only 16 participants received study intervention. | Posted | Median | Inter-Quartile Range | months | Up to 6 years |
|
|
|
| Secondary | Failure Rate | Failure rate will be reported as the incidence of biochemical or clinical failure. Biochemical failure is defined is an increase of 2 or greater from nadir of Prostate Specific Antigen (PSA) levels. Clinical Failure is defined as newly identified extension outside the prostate after initial regression, or urinary obstructive symptoms with carcinoma or regional/distant failure due to radiographic evidence metastasis. | Only 16 participants received study intervention. | Posted | Count of Participants | Participants | Up to 6 years |
|
|
|
| Secondary | EPIC SF-12 Scores | Health-related Quality of Life (HRQOL) will be measured using the Expanded Prostate Cancer Index Composite and Medical Outcomes Study SF-12 (EPIC SF-12) to evaluate patient function and satisfaction after prostate cancer treatment. Response options for each item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better HRQOL. | Only 16 participants received study intervention. Not all participants completed the survey at all time points. | Posted | Mean | Standard Deviation | score on a scale | At baseline, at last week of treatment (Up to 8 weeks), at 6 weeks after treatment (Up to 14 weeks), at 3 months after treatment (Up to 20 weeks), at 9 months after treatment (Up to 44 weeks). |
|
|
|
| Secondary | MAX-PC Scores | Health-related quality of life (HRQOL) will be measured using the scores on the Modified 18-item Memorial Anxiety Scale for Prostate Cancer (MAX-PC). The scale consists of 18 items (e.g. "I thought about prostate cancer even though I didn't mean to.") scored on a scale from 0 ("not at all") to 3 ("often"). Total scores range from 0 to 54, with higher scores indicating higher levels of anxiety. | Only 16 participants received study intervention. Not all participants completed the survey at all time points. | Posted | Mean | Standard Deviation | score on a scale | At baseline, at last week of treatment (Up to 8 weeks), at 6 weeks after treatment (Up to 14 weeks), at 3 months after treatment (Up to 20 weeks), at 9 months after treatment (Up to 44 weeks) |
|
|
|
| Secondary | Biomarker Expression in Prostate Tumor Regions | The amount of biomarker expression will be evaluated via immunohistochemistry (IHC) from ultrasound guided prostate biopsy tissue samples for both functional MRI suspicious regions and those that are not suspicious. | While tissue was collected for biomarker, none of the samples were analyzed because of insufficient patient numbers and power to draw conclusions. These types of analyses are done in batches and we never reached an appropriate threshold of cases to perform even exploratory analyses. No samples have been analyzed for biomarkers using IHC. | Posted | Up to 3 years |
|
|
| Secondary | Incidence of Circulating Free DNA | Incidence of circulating free DNA, as assessed from blood samples. | While blood was collected for cfDNA assessment, none of the samples were analyzed because of insufficient patient numbers and power to draw conclusions. These types of analyses are done in batches and we never reached an appropriate threshold of cases to perform even exploratory analyses. No samples have been analyzed for cfDNA. | Posted | Up to 3 years |
|
|
| 0 |
| 9 |
| 2 |
| 9 |
| 9 |
| 9 |
| EG001 | Arm II: HTIMRT | Participants in this group will receive the Hypofractionated Targeted Intensity Modulated Radiotherapy (HTIMRT) consisting of 38 fractions over 7.5 weeks. HTIMRT: Dose escalation to the Multiparametric MRI (MP-MRI) by dose painting at 2.35-2.40 Gy per fraction, while the rest of the Clinical Target Volume (CTV) receives 2.0 Gy a fraction to 76 Gy. The hypofractionated targeted (HT) boost region will receive an absolute dose of 89.3-91.2 Gy. Assuming an α/β ratio of 3.0, this would be equivalent to 95.5 Gy in 2.0 Gy fractions. | 1 | 7 | 3 | 7 | 7 | 7 |
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Confusion | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hematuria | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypotension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Urinary Incontinence | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Cystitis noninfective | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Depression | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Edema Limbs | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Ejaculation Disorder | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
|
| Low Testosterone | Endocrine disorders | CTCAE (4.0) | Systematic Assessment |
|
| Erectile Dysfunction | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
|
| Erythema multiforme | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fecal Incontinence | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Blood on Rectum | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hard Stool | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hematuria | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hemorrhoids | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hot Flashes | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypertriglyceridemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Low Testosterone | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Libido decreased | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Papulopustular rash | Infections and infestations | CTCAE (4.0) | Systematic Assessment | Testicular tenderness |
|
| Pelvic Pain | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
|
| Penile Pain | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
|
| Proctitis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Prostatic Obstruction | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
|
| Rectal Hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Rectal Pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Renal and Urinary Disorder - Other | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Low Testosterone | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
|
| Testicular Disorder | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment | Atrophic testicle |
|
| Testicular Disorder | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment | Decreased Testosterone Level |
|
| Testicular Pain | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
|
| Urinary Frequency | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Urinary Incontinence | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Urinary Retention | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Urinary Tract Infection | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Urinary Tract Obstruction | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Urinary Tract Pain | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Urinary Urgency | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Bloating | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Polycitemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Bone Pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Chest Pain - Cardiac | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Creatinine Increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Ear Pain | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Fever | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Gastroesophageal reflux disease | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hearing impaired | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Upper Respiratory Infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Movements involuntary | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Neck Pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Basal Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Systematic Assessment |
|
| Irritated Seborrheic Keratosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Systematic Assessment |
|
| Pain | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pain in Extremity | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment | Right knee pain |
|
| Penile Infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Platelet count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Seizure | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Squamous Cell Carcinoma in SITU Bowens Disease | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Skin Infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Skin ulceration | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Sore throat | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Weight gain | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Wound dehiscence | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Wrist fracture | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| Treatment-related Grade 3 or higher Acute Toxicity |
|
| Treatment-related Late Toxicity (>3 months after completing treatment) |
|
| Treatment-related Grade 3 or higher Late Toxicity |
|
| Urinary Function (Incontinence): Last week of treatment (Up to 8 weeks) |
|
|
| Urinary Function (Incontinence): 6 weeks after treatment (Up to 14 weeks) |
|
|
| Urinary Function (Incontinence): 3 months after treatment (Up to 20 weeks) |
|
|
| Urinary Function (Incontinence): 9 months after treatment (Up to 44 weeks) |
|
|
| Urinary Symptoms (Irritative/Obstructive): Baseline (Prior to treatment) |
|
|
| Urinary Symptoms (Irritative/Obstructive): Last week of treatment (Up to 8 weeks) |
|
|
| Urinary Symptoms (Irritative/Obstructive): 6 weeks after treatment (Up to 14 weeks) |
|
|
| Urinary Irritative/Obstructive: 3 months after treatment (Up to 20 weeks) |
|
|
| Urinary Irritative/Obstructive: 9 months after treatment (Up to 44 weeks) |
|
|
| Bowel Habits: Baseline (Prior to treatment) |
|
|
| Bowel Habits: Last week of treatment (Up to 8 weeks) |
|
|
| Bowel Habits: 6 weeks after treatment (Up to 14 weeks) |
|
|
| Bowel Habits: 3 months after treatment (Up to 20 weeks) |
|
|
| Bowel Habits: 9 months after treatment (Up to 44 weeks) |
|
|
| Sexual Function: Baseline (Prior to treatment) |
|
|
| Sexual Function: Last week of treatment (Up to 8 weeks) |
|
|
| Sexual Function: 6 weeks after treatment (Up to 14 weeks) |
|
|
| Sexual Function: 3 months after treatment (Up to 20 weeks) |
|
|
| Sexual Function: 9 months after treatment (Up to 44 weeks) |
|
|
| Hormonal Function: Baseline (Prior to treatment) |
|
|
| Hormonal Function: Last week of treatment (Up to 8 weeks) |
|
|
| Hormonal Function: 6 weeks after treatment (Up to 14 weeks) |
|
|
| Hormonal Function: 3 months after treatment (Up to 20 weeks) |
|
|
| Hormonal Function: 9 months after treatment (Up to 44 weeks) |
|
|
| Last week of treatment (Up to 8 weeks) |
|
|
| 6 weeks after treatment (Up to 14 weeks) |
|
|
| 3 months after treatment (Up to 20 weeks) |
|
|
| 9 months after treatment (Up to 44 weeks) |
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