Hormone Suppression and Radiation Therapy for 6 Months With/Without Docetaxel for High Risk Prostate Cancer

• Sponsor: Dana-Farber Cancer Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT00116142
• Collaborator: Sanofi (Industry)
• Enrollment: 350
• Location: 1
• Arms: 2
• Duration (Months): 180.9
• Patients Per Site Per Month: 1.9

Study Details

Study Description

Brief Summary

This randomized study is looking at the benefits of using docetaxel (chemotherapy) added to one of the standard treatments (radiation and hormones) for men with high-risk prostate cancer.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Drug: Docetaxel; Drug: Androgen Hormonal Suppression and Radiation; Drug: Androgen Suppression Therapy and Radiation Therapy	Phase 3

Detailed Description

Radiation therapy plus six months of hormone therapy is one standard way of treating men with high-risk prostate cancer. In this study, we want to see whether or not adding the chemotherapy drug docetaxel (Taxotere)will make this treatment more effective. Docetaxel has shown a benefit in median survival when given to men who have become resistant to hormonal therapy and in men who have metastatic prostate cancer (spread to other areas of the body).

Study Design

• Study Type: Interventional
• Actual Enrollment: 350 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Docetaxel Plus 6-month Androgen Suppression and Radiation Therapy Versus 6-month Androgen Suppression and Radiation Therapy for Patients With High Risk Localized or Locally Advanced Prostate Cancer: A Randomized Controlled Trial
• Study Start Date: Jun 1, 2005
• Actual Primary Completion Date: Jun 29, 2020
• Actual Study Completion Date: Jun 29, 2020

Arms and Interventions

Arm	Intervention/Treatment
Other: Arm1: Androgen Suppression Therapy + Radiation Therapy Androgen Suppression Therapy and Radiation therapy	Drug: Androgen Hormonal Suppression and Radiation; Total Androgen Ablation and external beam radiation therapy; Drug: Androgen Suppression Therapy and Radiation Therapy; Total Androgen Ablation and External Beam Radiation Therapy
Experimental: Arm 2: Docetaxel + Androgen Suppression Therapy + Radiation Therapy Docetaxel plus androgen suppression therapy and radiation therapy	Drug: Docetaxel; 60 mg/m² q 3 weeks for 3 cycle at the start of treatment followed by weekly Docetaxel at 20 mg/m² per week beginning at week one of radiation therapy and continuing for seven weeks.; Other Names: Taxotere ; Drug: Androgen Hormonal Suppression and Radiation; Total Androgen Ablation and external beam radiation therapy; Drug: Androgen Suppression Therapy and Radiation Therapy; Total Androgen Ablation and External Beam Radiation Therapy

Outcome Measures

Primary Outcome Measures

1. 10-Year Restricted Mean Survival Time for Overall Survival [Following the end of RT patients were seen for follow up every 6 months for 5 years and annually thereafter, 10 years.]

   Overall survival (OS) was measured from the date of random assignment to death from any cause, censored at the date of last follow-up in surviving patients. The 10-Year Restricted Mean Survival Time was calculated as the area under the Kaplan Meier plot for OS, from randomization to 10-years follow-up

Secondary Outcome Measures

1. 10-year Biochemical Recurrence (PSA Failure) [PSA was measured following the end of RT, then every 6 months for 5 years and annually thereafter, 10 years]

   Time to biochemical recurrence was defined as the time from date of random assignment to the earliest of PSA failure or initiation of salvage therapy, or censored at the date of last disease assessment for those without PSA failure. PSA failure was defined according to the 2006 RTOG-ASTRO Phoenix definition (i.e., A PSA rise by 2 ng/mL or more above the nadir). 10-year biochemical recurrence rate was estimated from a competing risk model where non-prostate cancer death was counted as competing risk.

2. 10-year Prostate Cancer Mortality [Following the end of RT patients were seen for follow up every 6 months for 5 years and annually thereafter, 10 years.]

   Measured from the date of random assignment to date of death from prostate cancer, or censored at the date of last follow-up in surviving patients. Patients who died due to other reasons were counted as competing risk in a competing risk model.

3. Number of Participants With Acute Adverse Events [During study treatment or within 30 days of the last dose of study, up to 7.2 months from randomization]

   Adverse acute events were reported via the clinical database only for toxicities considered reportable via the SAE mechanism (those of grade 2 and grade 3 events that are unexpected and possibly, probably, or definitely related/associated with treatment; or all grade 4 and grade 5 events). Common Toxicity Criteria Volume 3.0 (CTCAE) is used for this study.

4. Number of Participants With Late Adverse Events, Any Grade and Attribution [Every 6 months post radiation therapy for 5 years (+/-90 days), then annually, up to 13.9 years from randomization]

   Late adverse events will be focused on GU/GI including Urinary/Fecal Incontinence, Hematuria, Diarrhea, Rectal Bleeding and other.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Biopsy proven prostate cancer

• Clinical Tumor Category T1b, T1c, T2a and PSA greater than (>) 10 or Gleason score equal or greater than 4+3=7 or PSA velocity > 2.0 ng/ml per year and also eligible patients with tumor category T2c, T3a, T3b, or T4 as per 2002 AJCC guidelines. Any minor tertiary grade of Gleason 5; Biopsy Proven or Radiographic (erMRI Seminal Vesicle Invasion); Gleason = or > 3+4=7 with 50% or more cores positive

• Negative bone scan

• Lymph node assessment by CT or MR

• Adequate hematologic function (Blood Counts)

• Adequate liver functions (blood tests)

• ECOG performance Status 0 or 1

• Peripheral neuropathy must be =< grade 1

• PSA obtained within 3 months of entry

Exclusion Criteria:

• Prior history of malignancy that are < 5 years except for cancers found to be "in-situ" and would not likely impact a patient's life expectancy with appropriate medical management.

• Prior pelvic radiation therapy

• Prior hormonal therapy (up to 4 weeks prior to enrollment allowed)

• Individuals unable to tolerate lying still 5 - 10 minutes

• Patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 90.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dana-Farber Cancer Institute and (Sanofi-Aventis Consortium)	Boston	Massachusetts	United States	02115

Sponsors and Collaborators

• Dana-Farber Cancer Institute
• Sanofi

Investigators

• Principal Investigator: Anthony V. D'Amico, MD, PhD, Dana-Farber Cancer Institute

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 2, 2005

More Information

Publications

None provided.

• Responsible Party: Anthony V. D'Amico, MD, PhD, Principal Investigator, Dana-Farber Cancer Institute
• ClinicalTrials.gov Identifier: NCT00116142
• Other Study ID Numbers: 05-043
• First Posted: Jun 28, 2005
• Last Update Posted: Jan 11, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Anthony V. D'Amico, MD, PhD, Principal Investigator, Dana-Farber Cancer Institute: Prostate Cancer; Hormone Refractory; Metastatic; Localized; Locally Advanced; Prostate Cancer - High Risk Localized or Locally Advanced
• Additional relevant MeSH terms: Prostatic Neoplasms; Ascorbic Acid; Docetaxel; Methyltestosterone; Androgens; Estrogens, Conjugated (USP)

Study Results

Participant Flow

Recruitment Details	9/21/2005 to 1/13/2015

Arm/Group Title	Arm1: Androgen Suppression Therapy + Radiation Therapy	Arm2: Docetaxel + Androgen Suppression Therapy + Radiation Therapy
Arm/Group Description	Androgen Suppression Therapy + Radiation therapy Weeks 1-9: total androgen suppression Weeks 10-17: total androgen suppression and external beam radiation Weeks 18-26: total androgen suppression	Docetaxel + Androgen Suppression Therapy + Radiation Therapy Weeks 1-9: total androgen suppression and docetaxel 60 mg/m2/q3 weeks x 3 cycles Weeks 10-17: total androgen suppression + external beam radiation therapy + docetaxel 20 mg/m2/week beginning at week 10 x 7 cycles Weeks 18-26: total androgen suppression
Period Title: Overall Study
STARTED	175	175
Treated	174	171
COMPLETED	156	155
NOT COMPLETED	19	20

Baseline Characteristics

Arm/Group Title	Arm1: Androgen Suppression Therapy + Radiation Therapy	Arm2: Docetaxel + Androgen Suppression Therapy + Radiation Therapy	Total
Arm/Group Description	Androgen Suppression Therapy + Radiation therapy Weeks 1-9: total androgen suppression Weeks 10-17: total androgen suppression and external beam radiation Weeks 18-26: total androgen suppression	Docetaxel + Androgen Suppression Therapy + Radiation Therapy Weeks 1-9: total androgen suppression and docetaxel 60 mg/m2/q3 weeks x 3 cycles Weeks 10-17: total androgen suppression + external beam radiation therapy + docetaxel 20 mg/m2/week beginning at week 10 x 7 cycles Weeks 18-26: total androgen suppression	Total of all reporting groups
Overall Participants	175	175	350
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	66	66	66
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	175 100%	175 100%	350 100%
Race/Ethnicity, Customized (Count of Participants)
White	139 79.4%	132 75.4%	271 77.4%
Black or African American	4 2.3%	5 2.9%	9 2.6%
Asian	3 1.7%	1 0.6%	4 1.1%
Other	29 16.6%	37 21.1%	66 18.9%
Region of Enrollment (Count of Participants)
United States	110 62.9%	102 58.3%	212 60.6%
Australia	62 35.4%	69 39.4%	131 37.4%
New Zealand	3 1.7%	4 2.3%	7 2%

Outcome Measures

1. Primary Outcome

Title	10-Year Restricted Mean Survival Time for Overall Survival
Description	Overall survival (OS) was measured from the date of random assignment to death from any cause, censored at the date of last follow-up in surviving patients. The 10-Year Restricted Mean Survival Time was calculated as the area under the Kaplan Meier plot for OS, from randomization to 10-years follow-up
Time Frame	Following the end of RT patients were seen for follow up every 6 months for 5 years and annually thereafter, 10 years.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm1: Androgen Suppression Therapy + Radiation Therapy	Arm2: Docetaxel + Androgen Suppression Therapy + Radiation Therapy
Arm/Group Description	Androgen Suppression Therapy + Radiation Therapy Weeks 1-9: total androgen suppression Weeks 10-17: total androgen suppression and external beam radiation Weeks 18-26: total androgen suppression	Docetaxel + Androgen Suppression Therapy + Radiation Therapy Weeks 1-9: total androgen suppression and docetaxel 60 mg/m2/q3 weeks x 3 cycles Weeks 10-17: total androgen suppression + external beam radiation therapy + docetaxel 20 mg/m2/week beginning at week 10 x 7 cycles Weeks 18-26: total androgen suppression
Measure Participants	175	175
Mean (Standard Error) [years]	8.82 (0.19)	9.11 (0.15)

2. Secondary Outcome

Title	10-year Biochemical Recurrence (PSA Failure)
Description	Time to biochemical recurrence was defined as the time from date of random assignment to the earliest of PSA failure or initiation of salvage therapy, or censored at the date of last disease assessment for those without PSA failure. PSA failure was defined according to the 2006 RTOG-ASTRO Phoenix definition (i.e., A PSA rise by 2 ng/mL or more above the nadir). 10-year biochemical recurrence rate was estimated from a competing risk model where non-prostate cancer death was counted as competing risk.
Time Frame	PSA was measured following the end of RT, then every 6 months for 5 years and annually thereafter, 10 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm1: Androgen Suppression Therapy + Radiation Therapy	Arm2: Docetaxel + Androgen Suppression Therapy + Radiation Therapy
Arm/Group Description	Androgen Suppression Therapy and Radiation Therapy Weeks 1-9: total androgen suppression Weeks 10-17: total androgen suppression and external beam radiation Weeks 18-26: total androgen suppression	Docetaxel + Androgen Suppression Therapy and Radiation Therapy Weeks 1-9: total androgen suppression and docetaxel 60 mg/m2/q3 weeks x 3 cycles Weeks 10-17: total androgen suppression + external beam radiation therapy + docetaxel 20 mg/m2/week beginning at week 10 x 7 cycles Weeks 18-26: total androgen suppression
Measure Participants	175	175
Number (95% Confidence Interval) [percentage of subjects]	48	54

3. Secondary Outcome

Title	10-year Prostate Cancer Mortality
Description	Measured from the date of random assignment to date of death from prostate cancer, or censored at the date of last follow-up in surviving patients. Patients who died due to other reasons were counted as competing risk in a competing risk model.
Time Frame	Following the end of RT patients were seen for follow up every 6 months for 5 years and annually thereafter, 10 years.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm1: Androgen Suppression Therapy + Radiation Therapy	Arm2: Docetaxel + Androgen Suppression Therapy + Radiation Therapy
Arm/Group Description	Androgen suppression Therapy + Radiation Therapy Weeks 1-9: total androgen suppression Weeks 10-17: total androgen suppression and external beam radiation Weeks 18-26: total androgen suppression	Docetaxel + Androgen Suppression Therapy and Radiation Therapy Weeks 1-9: total androgen suppression and docetaxel 60 mg/m2/q3 weeks x 3 cycles Weeks 10-17: total androgen suppression + external beam radiation therapy + docetaxel 20 mg/m2/week beginning at week 10 x 7 cycles Weeks 18-26: total androgen suppression
Measure Participants	175	175
Number (95% Confidence Interval) [percentage of subjects]	11	15

4. Secondary Outcome

Title	Number of Participants With Acute Adverse Events
Description	Adverse acute events were reported via the clinical database only for toxicities considered reportable via the SAE mechanism (those of grade 2 and grade 3 events that are unexpected and possibly, probably, or definitely related/associated with treatment; or all grade 4 and grade 5 events). Common Toxicity Criteria Volume 3.0 (CTCAE) is used for this study.
Time Frame	During study treatment or within 30 days of the last dose of study, up to 7.2 months from randomization

Outcome Measure Data

Analysis Population Description

Adverse acute events were evaluated in patients who received at least one dose of protocol treatment (174 out of 175 subjects in Arm1, 171 out of 175 subjects in Arm2).

Arm/Group Title	Arm1: Androgen Suppression Therapy + Radiation Therapy	Arm2: Docetaxel + Androgen Suppression Therapy + Radiation Therapy
Arm/Group Description	Androgen Suppression Therapy + Radiation Therapy Weeks 1-9: total androgen suppression Weeks 10-17: total androgen suppression and external beam radiation Weeks 18-26: total androgen suppression	Docetaxel + Androgen Suppression Therapy + Radiation Therapy Weeks 1-9: total androgen suppression and docetaxel 60 mg/m2/q3 weeks x 3 cycles Weeks 10-17: total androgen suppression + external beam radiation therapy + docetaxel 20 mg/m2/week beginning at week 10 x 7 cycles Weeks 18-26: total androgen suppression
Measure Participants	174	171
Count of Participants [Participants]	18 10.3%	46 26.3%

5. Secondary Outcome

Title	Number of Participants With Late Adverse Events, Any Grade and Attribution
Description	Late adverse events will be focused on GU/GI including Urinary/Fecal Incontinence, Hematuria, Diarrhea, Rectal Bleeding and other.
Time Frame	Every 6 months post radiation therapy for 5 years (+/-90 days), then annually, up to 13.9 years from randomization

Outcome Measure Data

Analysis Population Description

Adverse late event was evaluated in patients who received at least one dose of protocol treatment (174 out of 175 subjects in Arm1, 171 out of 175 subjects in Arm2).

Arm/Group Title	Arm1: Androgen Suppression Therapy + Radiation Therapy	Arm2: Docetaxel + Androgen Suppression Therapy + Radiation Therapy
Arm/Group Description	Androgen Suppression Therapy and Radiation Therapy Weeks 1-9: total androgen suppression Weeks 10-17: total androgen suppression and external beam radiation Weeks 18-26: total androgen suppression	Docetaxel + Androgen Suppression Therapy and Radiation Therapy Weeks 1-9: total androgen suppression and docetaxel 60 mg/m2/q3 weeks x 3 cycles Weeks 10-17: total androgen suppression + external beam radiation therapy + docetaxel 20 mg/m2/week beginning at week 10 x 7 cycles Weeks 18-26: total androgen suppression
Measure Participants	174	171
Count of Participants [Participants]	128 73.1%	140 80%

Adverse Events

Time Frame	Up to 13.9 years from randomization.
Adverse Event Reporting Description	Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
Arm/Group Title	Arm1: Androgen Suppression Therapy + Radiation Therapy		Arm 2: Docetaxel + Androgen Suppression Therapy + Radiation Therapy
Arm/Group Description	Androgen Suppression Therapy and Radiation therapy Androgen Hormonal Suppression and Radiation: Total Androgen Ablation and external beam radiation therapy Androgen Suppression Therapy and Radiation Therapy: Total Androgen Ablation and External Beam Radiation Therapy		Docetaxel plus androgen suppression therapy and radiation therapy Docetaxel: 60 mg/m² q 3 weeks for 3 cycle at the start of treatment followed by weekly Docetaxel at 20 mg/m² per week beginning at week one of radiation therapy and continuing for seven weeks. Androgen Hormonal Suppression and Radiation: Total Androgen Ablation and external beam radiation therapy Androgen Suppression Therapy and Radiation Therapy: Total Androgen Ablation and External Beam Radiation Therapy
All Cause Mortality
	Arm1: Androgen Suppression Therapy + Radiation Therapy		Arm 2: Docetaxel + Androgen Suppression Therapy + Radiation Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	45/175 (25.7%)		44/175 (25.1%)
Serious Adverse Events
	Arm1: Androgen Suppression Therapy + Radiation Therapy		Arm 2: Docetaxel + Androgen Suppression Therapy + Radiation Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	63/174 (36.2%)		87/171 (50.9%)
Blood and lymphatic system disorders
Febrile neutropenia	0/174 (0%)		4/171 (2.3%)
Cardiac disorders
Cardiac-ischemia	1/174 (0.6%)		1/171 (0.6%)
Atrial fibrillation	0/174 (0%)		2/171 (1.2%)
Cardiac-other	0/174 (0%)		4/171 (2.3%)
Endocrine disorders
Endocrine-other	1/174 (0.6%)		0/171 (0%)
Gastrointestinal disorders
Perforation, colon	0/174 (0%)		1/171 (0.6%)
Ulcer, duodenum	0/174 (0%)		1/171 (0.6%)
Constipation	2/174 (1.1%)		1/171 (0.6%)
Proctitis	1/174 (0.6%)		3/171 (1.8%)
Incontinence, anal	7/174 (4%)		6/171 (3.5%)
Rectum, hemorrhage	9/174 (5.2%)		7/171 (4.1%)
GI-other	10/174 (5.7%)		9/171 (5.3%)
Diarrhea w/o prior colostomy	9/174 (5.2%)		17/171 (9.9%)
Distention/bloating, abdominal	1/174 (0.6%)		0/171 (0%)
Enteritis	1/174 (0.6%)		0/171 (0%)
Nausea	2/174 (1.1%)		0/171 (0%)
General disorders
Fever w/o neutropenia	0/174 (0%)		1/171 (0.6%)
Constitutional, other	1/174 (0.6%)		0/171 (0%)
Death - sudden death	1/174 (0.6%)		0/171 (0%)
Fatigue	2/174 (1.1%)		0/171 (0%)
Hepatobiliary disorders
Liver dysfunction/failure	0/174 (0%)		1/171 (0.6%)
Immune system disorders
Allergic reaction	0/174 (0%)		2/171 (1.2%)
Infections and infestations
Infection Gr0-2 neut, urinary tract	0/174 (0%)		1/171 (0.6%)
Infection w/ gr 3-4 neut, blood	0/174 (0%)		1/171 (0.6%)
Infection w/ unk ANC lung	0/174 (0%)		1/171 (0.6%)
Infection-other	0/174 (0%)		2/171 (1.2%)
Infection Gr0-2 neut, lung	1/174 (0.6%)		0/171 (0%)
Injury, poisoning and procedural complications
Bladder anastomotic leak	2/174 (1.1%)		1/171 (0.6%)
C5 tetraplegia	0/174 (0%)		1/171 (0.6%)
Investigations
Weight loss	1/174 (0.6%)		0/171 (0%)
Leukocytes	0/174 (0%)		1/171 (0.6%)
Neutrophils	0/174 (0%)		8/171 (4.7%)
Metabolism and nutrition disorders
Anorexia	0/174 (0%)		1/171 (0.6%)
Hyperglycemia	0/174 (0%)		1/171 (0.6%)
Musculoskeletal and connective tissue disorders
Musculoskeletal/soft tissue-other	0/174 (0%)		1/171 (0.6%)
Nervous system disorders
CNS cerebrovascular ischemia	0/174 (0%)		1/171 (0.6%)
Psychiatric disorders
Depression	2/174 (1.1%)		0/171 (0%)
Renal and urinary disorders
Cystitis	1/174 (0.6%)		1/171 (0.6%)
Urinary retention	4/174 (2.3%)		3/171 (1.8%)
Incontinence urinary	11/174 (6.3%)		8/171 (4.7%)
Bladder, hemorrhage	0/174 (0%)		9/171 (5.3%)
Urinary frequency/urgency	10/174 (5.7%)		18/171 (10.5%)
Renal/GU-other	17/174 (9.8%)		27/171 (15.8%)
Bladder spasms	1/174 (0.6%)		0/171 (0%)
Bladder, hemorrhage	10/174 (5.7%)		0/171 (0%)
Reproductive system and breast disorders
Gynecomastia	0/174 (0%)		1/171 (0.6%)
Erectile impotence	3/174 (1.7%)		6/171 (3.5%)
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory-other	0/174 (0%)		1/171 (0.6%)
(ARDS)	0/174 (0%)		1/171 (0.6%)
Bronchospasm, wheezing	0/174 (0%)		1/171 (0.6%)
Dyspnea	0/174 (0%)		2/171 (1.2%)
Skin and subcutaneous tissue disorders
Skin-other	0/174 (0%)		1/171 (0.6%)
Vascular disorders
Thrombosis/thrombus/embolism	0/174 (0%)		1/171 (0.6%)
Hot flashes	1/174 (0.6%)		1/171 (0.6%)
Other (Not Including Serious) Adverse Events
	Arm1: Androgen Suppression Therapy + Radiation Therapy		Arm 2: Docetaxel + Androgen Suppression Therapy + Radiation Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	128/174 (73.6%)		142/171 (83%)
Cardiac disorders
Cardiac-other	0/174 (0%)		1/171 (0.6%)
Gastrointestinal disorders
Constipation	24/174 (13.8%)		17/171 (9.9%)
Diarrhea w/o prior colostomy	42/174 (24.1%)		50/171 (29.2%)
Dyspepsia	0/174 (0%)		2/171 (1.2%)
GI-other	31/174 (17.8%)		34/171 (19.9%)
Incontinence, anal	21/174 (12.1%)		32/171 (18.7%)
Nausea	0/174 (0%)		2/171 (1.2%)
Proctitis	0/174 (0%)		2/171 (1.2%)
Rectum, hemorrhage	49/174 (28.2%)		41/171 (24%)
Stenosis (incl anastomotic) small bowel	0/174 (0%)		1/171 (0.6%)
Upper GI, hemorrhage NOS	0/174 (0%)		1/171 (0.6%)
General disorders
Chest/thoracic pain NOS	2/174 (1.1%)		0/171 (0%)
Constitutional, other	1/174 (0.6%)		0/171 (0%)
Rigors/chills	0/174 (0%)		1/171 (0.6%)
Infections and infestations
Infection Gr0-2 neut, urinary tract	2/174 (1.1%)		2/171 (1.2%)
Infection w/ unk ANC wound	1/174 (0.6%)		0/171 (0%)
Infection-other	1/174 (0.6%)		0/171 (0%)
Injury, poisoning and procedural complications
Fracture	0/174 (0%)		1/171 (0.6%)
Bladder anastomotic leak	19/174 (10.9%)		25/171 (14.6%)
Investigations
ALT, SGPT	1/174 (0.6%)		0/171 (0%)
Metabolism and nutrition disorders
Anorexia	0/174 (0%)		1/171 (0.6%)
Nervous system disorders
Vasovagal episode	0/174 (0%)		2/171 (1.2%)
Psychiatric disorders
Depression	1/174 (0.6%)		0/171 (0%)
Renal and urinary disorders
Bladder spasms	1/174 (0.6%)		0/171 (0%)
Bladder, hemorrhage	23/174 (13.2%)		31/171 (18.1%)
Cystitis	1/174 (0.6%)		1/171 (0.6%)
Incontinence urinary	35/174 (20.1%)		52/171 (30.4%)
Renal/GU-other	70/174 (40.2%)		84/171 (49.1%)
Urinary frequency/urgency	49/174 (28.2%)		50/171 (29.2%)
Urinary retention	2/174 (1.1%)		6/171 (3.5%)
Reproductive system and breast disorders
Erectile impotence	5/174 (2.9%)		4/171 (2.3%)
Testicle, pain	0/174 (0%)		1/171 (0.6%)
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)	1/174 (0.6%)		0/171 (0%)
Pulmonary/Upper Respiratory-other	0/174 (0%)		1/171 (0.6%)
Vascular disorders
Hypertension	1/174 (0.6%)		0/171 (0%)
Hypotension	0/174 (0%)		2/171 (1.2%)
Thrombosis/thrombus/embolism	0/174 (0%)		1/171 (0.6%)

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.