A Safety and Efficacy Study of Prograf in the Prevention of Erectile Dysfunction After Radical Prostatectomy

This study has been completed.

Sponsor:

Information provided by:

Astellas Pharma Inc

ClinicalTrials.gov Identifier:

NCT00106392

First received: March 23, 2005

Last updated: November 15, 2010

Last verified: November 2010

History of Changes

Results First Received: September 30, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Prevention
Conditions:	Erectile Dysfunction Prostate Cancer
Interventions:	Drug: Tacrolimus Drug: Placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Tacrolimus	Preoperatively: Tacrolimus 2 mg oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Tacrolimus 3 mg oral daily at time of hospital discharge through 6 months of follow up.
Placebo	Preoperatively: Matching placebo oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Matching placebo oral daily at time of hospital discharge through 6 months of follow up.

Participant Flow: Overall Study

	Tacrolimus	Placebo
STARTED	62	69
Baseline Participants	59 ^[1]	65 ^[2]
Full Analysis Set (FAS)	53	61
COMPLETED	36	42
NOT COMPLETED	26	27

[1]	3 patients withdrew: 2 prior to surgery and study drug; 1 took study drug but did not have surgery
[2]	4 patients withdrew: all prior to surgery and study drug

Baseline Characteristics

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Reporting Groups

	Description
Tacrolimus	Preoperatively: Tacrolimus 2 mg oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Tacrolimus 3 mg oral daily at time of hospital discharge through 6 months of follow up.
Placebo	Preoperatively: Matching placebo oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Matching placebo oral daily at time of hospital discharge through 6 months of follow up.
Total	Total of all reporting groups

Baseline Measures

	Tacrolimus	Placebo	Total
Number of Participants [units: participants]	59	65	124
Age [units: years] Mean ± Standard Deviation	55.1 ± 6.2	54.1 ± 6.2	54.6 ± 6.2
Gender [units: participants]
Female	0	0	0
Male	59	65	124
Race/Ethnicity, Customized [units: Participants]
American Indian or Alaskan Native	0	1	1
Black or African American	4	1	5
White	55	63	118

Outcome Measures

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1. Primary:

Erectile Function Domain Score Between Treated and Untreated Groups [ Time Frame: 18 months ]

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2. Secondary:

Percentage of Patients Achieving Normal Spontaneous Erectile Function as Measured by the Erectile Function (EF) Domain Score [ Time Frame: 24 months ]

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3. Secondary:

Time Taken to Achieve Normalization of the Erectile Function (EF) Domain Score [ Time Frame: 24 months ]

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4. Secondary:

Percentage of Patients Considered Successful Responders to Impotence Medications [ Time Frame: 24 months ]

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5. Secondary:

Time to Achieve Response to Impotence Medications [ Time Frame: 24 months ]

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6. Secondary:

Continence Level as Quantified by Part I of the Prostate Health-Related Quality of Life Questionnaire [ Time Frame: 24 months ]

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Measure Type	Secondary
Measure Title	Continence Level as Quantified by Part I of the Prostate Health-Related Quality of Life Questionnaire
Measure Description	Part 1 Urinary Function- Prostate Health-Related Quality-of-Life (QOL) Questionnaire consists of 16 questions asking patients about their continence and urinary habits over the previous four weeks. The responses to all 16 of these questions were added together to calculate an overall score for urinary function. The minimum possible score is 16 and the maximum possible score is 79. A higher score indicates a lower continence level.
Time Frame	24 months
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The number of participants analyzed represents Full Analysis Set (FAS), which is defined as participants evaluated for Efficacy and Safety. Only participants with a Prostate Health-Related QOL questionnaire at 24 months were included in the calculation.

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

The number of participants analyzed represents Full Analysis Set (FAS), which is defined as participants evaluated for Efficacy and Safety.

Only participants with a Prostate Health-Related QOL questionnaire at 24 months were included in the calculation.

Reporting Groups

	Description
Tacrolimus	Preoperatively: Tacrolimus 2 mg oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Tacrolimus 3 mg oral daily at time of hospital discharge through 6 months of follow up.
Placebo	Preoperatively: Matching placebo oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Matching placebo oral daily at time of hospital discharge through 6 months of follow up.

Measured Values

	Tacrolimus	Placebo
Number of Participants Analyzed [units: participants]	39	47
Continence Level as Quantified by Part I of the Prostate Health-Related Quality of Life Questionnaire [units: Overall Score of Urinary Function] Median ( Full Range )	22.0 ( 16.0 to 49.0 )	22.0 ( 16.0 to 52.0 )

Statistical Analysis 1 for Continence Level as Quantified by Part I of the Prostate Health-Related Quality of Life Questionnaire

Groups ^[1]	All groups
Method ^[2]	Wilcoxon (Mann-Whitney)
P Value ^[3]	0.879

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS 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.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site’s manuscript at least 30 days prior to publication to ensure that no confidential information of Sponsor is included in the document.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Company makes no warranties or representations of any kind as to the posting, expressed or implied, including warranties of merchantability and fitness for a particular purpose, and shall not be liable for any damages.

Results Point of Contact:

Name/Title: Senior Medical Director, Medical Affairs
Organization: Astellas Pharma Global Development
e-mail: clinicaltrials@us.astellas.com

No publications provided

Responsible Party:	Sr Manager Clinical Trial Registries, Astellas Pharma US, Inc
ClinicalTrials.gov Identifier:	NCT00106392 History of Changes
Other Study ID Numbers:	20-03-001
Study First Received:	March 23, 2005
Results First Received:	September 30, 2010
Last Updated:	November 15, 2010
Health Authority:	United States: Institutional Review Board

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