Abiraterone, Radiotherapy and Short-Term Androgen Deprivation in Unfavorable Localized Prostate Cancer

• Sponsor: Duke University (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT01717053
• Collaborator: Janssen Pharmaceuticals (Industry)
• Enrollment: 37
• Locations: 3
• Arm: 1
• Anticipated Duration (Months): 98.4
• Patients Per Site: 12.3
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The addition of abiraterone acetate to standard treatment of radiotherapy and short-term androgen deprivation will increase the frequency of undetectable PSA.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Drug: Abiraterone acetate; Drug: Androgen deprivation; Radiation: Radiation Therapy; Drug: Prednisone	Phase 2

Detailed Description

This is a single arm two-site study of 37 men with unfavorable prostate cancer (defined as having a single high risk factor). Patients will concurrently initiate 6 months of standard-of-care GNRH agonist therapy and once daily abiraterone acetate/prednisone. After 2 months of lead-in hormonal treatment, definitive standard-of-care prostate/seminal vesicle radiotherapy will be delivered, to a total dose of 75-80 Gy.

Study Design

• Study Type: Interventional
• Actual Enrollment: 37 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Trial of Abiraterone Acetate, Radiotherapy and Short-Term Androgen Deprivation in Men With Unfavorable Risk Localized Prostate Cancer
• Actual Study Start Date: Jan 17, 2014
• Actual Primary Completion Date: Aug 24, 2017
• Anticipated Study Completion Date: Apr 1, 2022

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Abiraterone acetate Abiraterone Acetate, Radiotherapy and Short Term Androgen Deprivation. Prednisone will be prescribed concurrently with Abiraterone acetate.

Drug: Abiraterone acetate; 1000 mg orally once a day for 6 months.; Other Names: Zytiga ; Drug: Androgen deprivation; LHRH analog (at discretion of treating physician) will be administered over 6 months (for example, leuprolide acetate 22.5mg IM or goserelin acetate 10.8mg SC given every 3 months for 2 doses).; Radiation: Radiation Therapy; Daily (Monday-Friday) for 8 weeks, final dose of 75-80 Gy; Drug: Prednisone; 5 mg tablet once daily for 6 months.

Outcome Measures

Primary Outcome Measures

1. Percentage of Patients With Undetectable PSA at 1 Year [1 year]

   The percentage of patients with undetectable PSA after 1 year will be calculated. Undetectable PSA is defined as a measurement of <0.1 ng/mL.

Secondary Outcome Measures

1. Time to PSA Nadir [1 year]

   The median time in months to the lowest PSA value from the start of study therapy.

2. PSA Nadir Value [1 year, 2 years]

   The lowest PSA value from the start of study therapy.

3. Biochemical Progression-free Survival [up to 5 years]

   Disease progression defined as Phoenix RTOG definition of nadir + 2ng/ml or initiation of salvage therapy

4. Metastasis or Systemic Therapy [up to 5 years]

   Time to metastasis or systemic therapy

5. Testosterone Recovery [up to 5 years]

   Time to testosterone recovery

6. PSA < 1.5ng/ml in Setting of Non-castrate Testosterone [1 year, 2 years, 3 years, 4 years, 5 years]

   Proportion of men with 1, 2, 3, 4 and 5 year PSA < 1.5ng/ml in setting of non-castrate testosterone

7. Safety and Tolerability [6 months]

   The number of patients experiencing an adverse event of at least grade 3 that is possibly, probably, or definitely related to study therapy per CTCAE version 4.0.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• One of the following high risk criteria:

• Gleason Score 7 with PSA ≤ 20 ng/ml and clinical T1-2, or

• Gleason Score 8-10, PSA ≤ 20 ng/ml and clinical T1-2a, or

• PSA 10.1-40 ng/ml with GS < 7 and clinical T1-2, or

• Clinical T3 with Gleason Score < 7 and PSA ≤ 10 ng/ml.

• ECOG Performance Status ≤ 1

• Digital rectal exam within 90 days of registration on study

• CBC with differential with adequate bone marrow function defined as follows:

• Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3, Platelets > 100,000/µL and Hemoglobin ≥ 9g/dL

• Serum potassium ≥ 3.5 mEq/L

• Serum albumin > 3.0 g/dl

• Total bilirubin < 1.5 X of institutional upper limit of normal (ULN)

• AST(SGOT)/ALT(SGPT) < 1.5 X ULN

• Calculated creatinine clearance > 60 mL/min

• Age > 18 years

• Able to swallow a whole tablet and take abiraterone acetate on an empty stomach (defined as no food for two hours before and one hour after abiraterone acetate ingestion)

• Ability to understand and sign a written informed consent document

• Written authorization for use and release of health and research study information has been obtained

• Be willing/able to adhere to the prohibitions and restrictions specified in this protocol

• Subjects who have partners of childbearing potential must be willing to use a method of birth control with adequate barrier protections as determined acceptable by the principal investigator during the study and for 1 week after the last dose of abiraterone acetate.

Exclusion Criteria:

• Bone, visceral or soft tissue metastasis, including lymph nodes (>2 cm in longest diameter)

• Prior therapy for prostate cancer [Exceptions: LHRH agonist or antagonist may have been initiated within 30 days prior to enrollment. Bicalutamide may have been given within 60 days of enrollment as long as it has been stopped at least 7 days before enrollment and total duration was no longer than 30 days. This is to allow enrollment of those who have been given bicalutamide as a bridge for LHRH agonist/antagonist. It is highly unlikely a short non-overlapping course of bicalutamide will interact with abiraterone acetate in a measurable way. Previous alpha-reductase inhibitor use allowed IF patient has not been taking for at least 30 days prior to abiraterone acetate initiation, OR if alpha reductase inhibitor was not used as a primary treatment of prostate cancer and the PSA on alpha-reductase inhibitor remains within eligibility when doubled. ]

• Known serum testosterone ≤ 150 ng/dl or symptoms of hypogonadism (fatigue, hot flashes, hair loss, loss of muscle mass, osteoporosis, low libido, depression) prior to ADT initiation not explained by other medical co-morbidity OR history of testosterone supplement. If questionable, serum testosterone level greater than 150 ng/dl can be used to exclude hypogonadism.

• Previous malignancy within 3 years other than non-melanomatous skin cancer and non-muscle invasive bladder cancer

• Previous pelvic radiotherapy that would prevent prostate/SV irradiation

• Uncontrolled hypertension (systolic BP ≥ 160 mmHg or diastolic BP ≥ 95 mmHg). Patients with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive therapy

• History of gastrointestinal disorders that may interfere with the absorption of study drug (including gastric bypass surgery)

• Concurrent spironolactone use

• Significant concurrent medical condition that would make prednisone/prednisolone use contraindicated or would interfere with the patient's ability to participate in the trial

• Receiving any investigational agents currently or within 30 days prior to study screening

• Prior demonstrated hypersensitivity, intolerance or allergy to abiraterone acetate, prednisone or their excipients

• Active co-morbidity, defined as follows:

• Chronic liver disease with cirrhosis (Child-Pugh B or C) or active hepatitis B or C

• History of pituitary or adrenal dysfunction

• Poorly controlled diabetes mellitus (A1c >9% or history of complications including peripheral neuropathy, end organ damage, hospitalization, amputation)

• Poorly controlled glaucoma

• Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) Class III-IV heart disease or known cardiac ejection fraction measurement of < 50% at baseline.

• Clinical evidence of active infection of any type, including active or symptomatic viral hepatitis.

• Known immune deficiency and/or HIV-positive patients

• Any medical condition that warrants long-term corticosteroid use in excess of study dose

• Patients taking strong CYP3A4 inducers (e.g., phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital)

• Any condition that in the opinion of the Principal Investigator, would compromise the well-being of the subject or the study or prevent the subject from meeting or performing the study requirements

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Durham Regional Hospital	Durham	North Carolina	United States	27704
2	Duke University Medical Center	Durham	North Carolina	United States	27710
3	MD Anderson Cancer Center	Houston	Texas	United States	77030

Sponsors and Collaborators

• Duke University
• Janssen Pharmaceuticals

Investigators

• Principal Investigator: Daniel George, MD, Duke University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Apr 25, 2017

More Information

Publications

None provided.

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT01717053
• Other Study ID Numbers: Pro00044071
• First Posted: Oct 30, 2012
• Last Update Posted: Nov 3, 2021
• Last Verified: Oct 1, 2021

• Additional relevant MeSH terms: Prostatic Neoplasms; Prednisone; Abiraterone Acetate; Androgens

Study Results

Participant Flow

Arm/Group Title	Abiraterone+Radiotherapy+ADT
Arm/Group Description	Abiraterone Acetate, Radiotherapy and Short Term Androgen Deprivation. Prednisone will be prescribed concurrently with Abiraterone acetate.
Period Title: Overall Study
STARTED	37
COMPLETED	33
NOT COMPLETED	4

Baseline Characteristics

Arm/Group Title	Abiraterone+Radiotherapy+ADT
Arm/Group Description	Abiraterone Acetate, Radiotherapy and Short Term Androgen Deprivation. Prednisone will be prescribed concurrently with Abiraterone acetate.
Overall Participants	37
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	66.0 (5.3)
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	37 100%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	37 100%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	6 16.2%
White	31 83.8%
More than one race	0 0%
Unknown or Not Reported	0 0%

Outcome Measures

1. Primary Outcome

Title	Percentage of Patients With Undetectable PSA at 1 Year
Description	The percentage of patients with undetectable PSA after 1 year will be calculated. Undetectable PSA is defined as a measurement of <0.1 ng/mL.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

This analysis includes all patients that completed protocol therapy.

Arm/Group Title	Abiraterone+Radiotherapy+ADT
Arm/Group Description	Abiraterone Acetate, Radiotherapy and Short Term Androgen Deprivation. Prednisone will be prescribed concurrently with Abiraterone acetate.
Measure Participants	33
Number [percentage of participants]	52 140.5%

2. Secondary Outcome

Title	Time to PSA Nadir
Description	The median time in months to the lowest PSA value from the start of study therapy.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

This analysis includes all patients that completed protocol therapy.

Arm/Group Title	Abiraterone+Radiotherapy+ADT
Arm/Group Description	Abiraterone Acetate, Radiotherapy and Short Term Androgen Deprivation. Prednisone will be prescribed concurrently with Abiraterone acetate.
Measure Participants	33
Median (Full Range) [months]	8.9

3. Secondary Outcome

Title	PSA Nadir Value
Description	The lowest PSA value from the start of study therapy.
Time Frame	1 year, 2 years

Outcome Measure Data

Analysis Population Description

This analysis includes all patients that completed protocol therapy.

Arm/Group Title	Abiraterone+Radiotherapy+ADT
Arm/Group Description	Abiraterone Acetate, Radiotherapy and Short Term Androgen Deprivation. Prednisone will be prescribed concurrently with Abiraterone acetate.
Measure Participants	33
Year 1	0.03
Year 2	0.03

4. Secondary Outcome

Title	Biochemical Progression-free Survival
Description	Disease progression defined as Phoenix RTOG definition of nadir + 2ng/ml or initiation of salvage therapy
Time Frame	up to 5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

5. Secondary Outcome

Title	Metastasis or Systemic Therapy
Description	Time to metastasis or systemic therapy
Time Frame	up to 5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

6. Secondary Outcome

Title	Testosterone Recovery
Description	Time to testosterone recovery
Time Frame	up to 5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

7. Secondary Outcome

Title	PSA < 1.5ng/ml in Setting of Non-castrate Testosterone
Description	Proportion of men with 1, 2, 3, 4 and 5 year PSA < 1.5ng/ml in setting of non-castrate testosterone
Time Frame	1 year, 2 years, 3 years, 4 years, 5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

8. Secondary Outcome

Title	Safety and Tolerability
Description	The number of patients experiencing an adverse event of at least grade 3 that is possibly, probably, or definitely related to study therapy per CTCAE version 4.0.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

This analysis includes all patients that completed protocol therapy.

Arm/Group Title	Abiraterone+Radiotherapy+ADT
Arm/Group Description	Abiraterone Acetate, Radiotherapy and Short Term Androgen Deprivation. Prednisone will be prescribed concurrently with Abiraterone acetate.
Measure Participants	33
Number [participants]	12 32.4%

Adverse Events

Time Frame	6 months
Arm/Group Title	Abiraterone+Radiotherapy+ADT
Arm/Group Description	Abiraterone Acetate, Radiotherapy and Short Term Androgen Deprivation. Prednisone will be prescribed concurrently with Abiraterone acetate.
All Cause Mortality
	Abiraterone+Radiotherapy+ADT
	Affected / at Risk (%)	# Events
Total	0/37 (0%)
Serious Adverse Events
	Abiraterone+Radiotherapy+ADT
	Affected / at Risk (%)	# Events
Total	4/37 (10.8%)
General disorders
Fever	1/37 (2.7%)
Musculoskeletal and connective tissue disorders
Pain in extremity	1/37 (2.7%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Other, specify: Malignant melanoma	1/37 (2.7%)
Psychiatric disorders
Psychiatric disorders - Other, specify	1/37 (2.7%)
Renal and urinary disorders
Acute kidney injury	1/37 (2.7%)
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify: Bilateral pleural effusion	1/37 (2.7%)
Other (Not Including Serious) Adverse Events
	Abiraterone+Radiotherapy+ADT
	Affected / at Risk (%)	# Events
Total	36/37 (97.3%)
Blood and lymphatic system disorders
Anemia	4/37 (10.8%)
Cardiac disorders
Atrial fibrillation	1/37 (2.7%)
Cardiac disorders - Other, specify: Irregular heart beats	1/37 (2.7%)
Chest pain - cardiac	1/37 (2.7%)
Palpitations	1/37 (2.7%)
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify: ""slight off balance and fluid in ears""	1/37 (2.7%)
Ear and labyrinth disorders - Other, specify: Slight off balance	1/37 (2.7%)
Ear pain	1/37 (2.7%)
Vertigo	1/37 (2.7%)
Eye disorders
Blurred vision	2/37 (5.4%)
Dry eye	1/37 (2.7%)
Eye disorders - Other, specify: Left eye ""stye with morning crustiness""	1/37 (2.7%)
Gastrointestinal disorders
Abdominal distension	1/37 (2.7%)
Colitis	1/37 (2.7%)
Constipation	5/37 (13.5%)
Diarrhea	10/37 (27%)
Dry mouth	5/37 (13.5%)
Dyspepsia	3/37 (8.1%)
Esophageal pain	1/37 (2.7%)
Fecal incontinence	2/37 (5.4%)
Flatulence	1/37 (2.7%)
Gastrointestinal disorders - Other, specify: Bowel urgency	1/37 (2.7%)
Gastrointestinal disorders - Other, specify: Guaiac positive stools	1/37 (2.7%)
Gastrointestinal disorders - Other, specify: Intermittent ""mucous loose stool""	1/37 (2.7%)
Gastrointestinal disorders - Other, specify: Pt reports intermittent frank red blood on stool	1/37 (2.7%)
Gastrointestinal disorders - Other, specify: diverticulitis	1/37 (2.7%)
Gastrointestinal disorders - Other, specify: intermittent rectal bleeding	1/37 (2.7%)
Gastrointestinal disorders - Other, specify: urgency with bowels	1/37 (2.7%)
Gingival pain	1/37 (2.7%)
Hemorrhoids	2/37 (5.4%)
Nausea	4/37 (10.8%)
Oral pain	1/37 (2.7%)
Rectal pain	4/37 (10.8%)
Toothache	1/37 (2.7%)
Vomiting	3/37 (8.1%)
General disorders
Edema limbs	2/37 (5.4%)
Fatigue	24/37 (64.9%)
General disorders and administration site conditions - Other, specify: Injury left hand	1/37 (2.7%)
General disorders and administration site conditions - Other, specify: Occasional cramping	1/37 (2.7%)
General disorders and administration site conditions - Other, specify: Perineal pain	1/37 (2.7%)
Injection site reaction	1/37 (2.7%)
Irritability	3/37 (8.1%)
Neck edema	1/37 (2.7%)
Non-cardiac chest pain	1/37 (2.7%)
Pain	4/37 (10.8%)
Infections and infestations
Infections and infestations - Other, specify: C diff colitis	1/37 (2.7%)
Tooth infection	1/37 (2.7%)
Urinary tract infection	1/37 (2.7%)
Injury, poisoning and procedural complications
Bruising	2/37 (5.4%)
Burn	1/37 (2.7%)
Fall	1/37 (2.7%)
Injury, poisoning and procedural complications - Other, specify:Chigger bite	1/37 (2.7%)
Injury, poisoning and procedural complications - Other, specify: Injury to Right Shin	1/37 (2.7%)
Injury, poisoning and procedural complications - Other, specify: face injury	1/37 (2.7%)
Investigations
Alanine aminotransferase increased	12/37 (32.4%)
Alkaline phosphatase increased	3/37 (8.1%)
Aspartate aminotransferase increased	13/37 (35.1%)
Blood bilirubin increased	3/37 (8.1%)
Creatinine increased	1/37 (2.7%)
Investigations - Other, specify: Blood Urea Nitrogen 20(7-18); 20 (8-20)	1/37 (2.7%)
Investigations - Other, specify: Blood Urea Nitrogen 21 (8-20)	1/37 (2.7%)
Investigations - Other, specify: Blood Urea Nitrogen 23 (7-18); 20 (8-20)	1/37 (2.7%)
Investigations - Other, specify: Blood urea nitrogen 28;18	1/37 (2.7%)
Investigations - Other, specify: CO2 level (carbon dioxide) 31	1/37 (2.7%)
Investigations - Other, specify: CO2 level (carbon dioxide)31	1/37 (2.7%)
Investigations - Other, specify: CO2 level (carbon dioxide)31 (23-30)	1/37 (2.7%)
Investigations - Other, specify: Decreased ALT, <12 (7-56)	1/37 (2.7%)
Investigations - Other, specify: Elevated CO2 (Carbon Dioxide) level at 31 (23-30)	1/37 (2.7%)
Investigations - Other, specify: Increased Albumin 5.0 (3.5-4.7)	1/37 (2.7%)
Investigations - Other, specify: Increased CO2 (carbon dioxide) level, 31	1/37 (2.7%)
Investigations - Other, specify: Low Chloride 96 (98-108)	1/37 (2.7%)
Investigations - Other, specify: Low Chloride 97;on 3/31- 96 (98-108)	1/37 (2.7%)
Investigations - Other, specify: Low serum creatinine, 0.66	1/37 (2.7%)
Investigations - Other, specify: Minimally increased @ 32 (23-30)	1/37 (2.7%)
Investigations - Other, specify: Serum Carbon Dioxide Level 32;28 (23-30)	1/37 (2.7%)
Investigations - Other, specify: Serum Carbon Dioxide Level 34;29 (23-30)	1/37 (2.7%)
Investigations - Other, specify: Weight loss, 83.7 kg (88 kg on 6/4/15)	1/37 (2.7%)
Platelet count decreased	1/37 (2.7%)
Urine output decreased	1/37 (2.7%)
Weight gain	1/37 (2.7%)
Weight loss	2/37 (5.4%)
White blood cell decreased	1/37 (2.7%)
Metabolism and nutrition disorders
Acidosis	1/37 (2.7%)
Anorexia	2/37 (5.4%)
Hyperglycemia	8/37 (21.6%)
Hyperkalemia	1/37 (2.7%)
Hypocalcemia	1/37 (2.7%)
Hypokalemia	8/37 (21.6%)
Hyponatremia	3/37 (8.1%)
Metabolism and nutrition disorders - Other, specify: Possible mineralcorticoid excess (hypokalemia)	1/37 (2.7%)
Metabolism and nutrition disorders - Other, specify: elevated ALT/AST	1/37 (2.7%)
Musculoskeletal and connective tissue disorders
Arthralgia	1/37 (2.7%)
Back pain	2/37 (5.4%)
Chest wall pain	1/37 (2.7%)
Musculoskeletal and connective tissue disorder - Other, specify: Chronic left hip/sciatica pain	1/37 (2.7%)
Musculoskeletal and connective tissue disorder - Other, specify: Decreased strength & endurance	1/37 (2.7%)
Musculoskeletal and connective tissue disorder - Other, specify: L4-L5 procedure on 8/4/15	1/37 (2.7%)
Musculoskeletal and connective tissue disorder - Other, specify: Right Lower Extremity leg spasm	1/37 (2.7%)
Musculoskeletal and connective tissue disorder - Other, specify: Right flank pain	1/37 (2.7%)
Musculoskeletal and connective tissue disorder - Other, specify: bursitis, left knee	1/37 (2.7%)
Musculoskeletal and connective tissue disorder - Other, specify: restless legs	1/37 (2.7%)
Pain in extremity	2/37 (5.4%)
Nervous system disorders
Dizziness	4/37 (10.8%)
Dysgeusia	1/37 (2.7%)
Headache	4/37 (10.8%)
Memory impairment	2/37 (5.4%)
Nervous system disorders - Other, specify: Chronic sciatic back pain	1/37 (2.7%)
Nervous system disorders - Other, specify: Pre-treatment, chronic sciatic back pain	1/37 (2.7%)
Nervous system disorders - Other, specify: lightheaded, when standing	1/37 (2.7%)
Paresthesia	2/37 (5.4%)
Presyncope	1/37 (2.7%)
Somnolence	1/37 (2.7%)
Psychiatric disorders
Agitation	1/37 (2.7%)
Anxiety	1/37 (2.7%)
Depression	1/37 (2.7%)
Insomnia	5/37 (13.5%)
Libido decreased	6/37 (16.2%)
Psychiatric disorders - Other, specify	1/37 (2.7%)
Restlessness	1/37 (2.7%)
Renal and urinary disorders
Cystitis noninfective	4/37 (10.8%)
Hematuria	2/37 (5.4%)
Renal and urinary disorders - Other, specify: Dysuria	1/37 (2.7%)
Renal and urinary disorders - Other, specify: Increased urination	1/37 (2.7%)
Renal and urinary disorders - Other, specify: Nocturia	2/37 (5.4%)
Renal and urinary disorders - Other, specify: Slow urinary stream	1/37 (2.7%)
Renal and urinary disorders - Other, specify: Urinary hesistancy	1/37 (2.7%)
Renal and urinary disorders - Other, specify: Urinary hesitancy	3/37 (8.1%)
Renal and urinary disorders - Other, specify: Weak urinary stream	1/37 (2.7%)
Renal and urinary disorders - Other, specify: nocturia	1/37 (2.7%)
Renal and urinary disorders - Other, specify: weak stream	1/37 (2.7%)
Urinary frequency	20/37 (54.1%)
Urinary incontinence	5/37 (13.5%)
Urinary retention	2/37 (5.4%)
Urinary tract pain	6/37 (16.2%)
Urinary urgency	5/37 (13.5%)
Reproductive system and breast disorders
Erectile dysfunction	3/37 (8.1%)
Gynecomastia	2/37 (5.4%)
Perineal pain	1/37 (2.7%)
Respiratory, thoracic and mediastinal disorders
Cough	5/37 (13.5%)
Dyspnea	4/37 (10.8%)
Laryngeal inflammation	1/37 (2.7%)
Nasal congestion	4/37 (10.8%)
Pleural effusion	1/37 (2.7%)
Postnasal drip	1/37 (2.7%)
Productive cough	2/37 (5.4%)
Respiratory, thoracic and mediastinal disorders - Other, specify: Dry nose	1/37 (2.7%)
Sleep apnea	1/37 (2.7%)
Sore throat	2/37 (5.4%)
Skin and subcutaneous tissue disorders
Dry skin	3/37 (8.1%)
Erythema multiforme	2/37 (5.4%)
Pruritus	2/37 (5.4%)
Rash maculo-papular	2/37 (5.4%)
Skin and subcutaneous tissue disorders - Other, specify:	1/37 (2.7%)
Skin and subcutaneous tissue disorders - Other, specify: Basal cell carcinoma of left ear	1/37 (2.7%)
Skin and subcutaneous tissue disorders - Other, specify: Melanoma of lower back	1/37 (2.7%)
Skin and subcutaneous tissue disorders - Other, specify: Melanoma of right shoulder	1/37 (2.7%)
Skin and subcutaneous tissue disorders - Other, specify: Soft non-tender area on lower leg	1/37 (2.7%)
Skin and subcutaneous tissue disorders - Other, specify: skin pallor, pale	1/37 (2.7%)
Vascular disorders
Hot flashes	28/37 (75.7%)
Hypertension	22/37 (59.5%)
Vascular disorders - Other, specify: Facial petechiae ""from force of vomiting"" per pt	1/37 (2.7%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.