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| ID | Type | Description | Link |
|---|---|---|---|
| ERECT, EPO | Other Identifier | Johns Hopkins Brady Urological Institute |
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This research study aims to explore the effectiveness of human erythropoietin versus placebo in promoting the recovery of erectile function in patients undergoing bilateral nerve-sparing radical retropubic prostatectomy for clinically localized prostate cancer.
Pre-clinical studies have shown erythropoietin potently promoted recovery of erectile function in rats and humans have similar receptors on penile tissues and the periprostatic neurovascular bundles. A clinical non-randomized study conducted in men undergoing radical prostatectomy demonstrated a benefit to recovery of erectile function.
Therefore, the hypothesis is that erythropoietin offers nerve protection in men undergoing nerve-sparing radical prostatectomy and results in a reduced degree of erectile dysfunction and also an improved rate of erection recovery following surgery.
This study will evaluate the effectiveness of erythropoietin versus placebo in the recovery of erectile function in patients undergoing bilateral nerve-sparing radical prostatectomy for prostate cancer.
Recent laboratory findings in rat models and on human urogenital tissues suggest that erythropoietin may play a role in protection of the cavernous nerves during surgery. Some degree of nerve trauma occurs during bilateral nerve-sparing radical prostatectomy, but for most it is temporary. Erythropoietin will be studied as an investigational drug for enhancement of erectile function postoperatively in a prospective, randomized study. Erythropoietin has been used in many men undergoing open radical prostatectomy in the past according to FDA indications for preparation for noncardiac, nonvascular surgery with a high risk of blood loss. Evidence also suggests it is safe with no demonstration of increased risk of venous thromboembolism (blood clots) or cardiac events for men with prostate cancer undergoing radical prostatectomy.
The length of the study is 12 months and involves receiving a dose of study drug or placebo on the day before surgery, the day of surgery, and the day following surgery. The dose is given by subcutaneous injection. The study will also require the completion of questionnaires which will be completed online every three months until study completion (at 3, 6, 9, and 12 months) to assess outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Erythropoietin (EPO) | Experimental | 20,000 units of EPO given on the day before surgery, the day of surgery, and the day after surgery. |
|
| Placebo | Placebo Comparator | Placebo doses given the day before surgery, the day of surgery, and the day after surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Saline injection (solution prepared by research pharmacy) subcutaneously given the day before surgery, day of surgery, and the day after surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Erectile Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire Erectile Function Domain | Survey measuring erectile function using the IIEF (erectile function domain only) with overall score ranging from 0 to 30 where higher scores represent better erectile function. | At 6 months post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Erectile Function as Assessed by the IIEF Questionnaire Erectile Function Domain | Survey measuring erectile function using the IIEF (erectile function domain only) with overall score ranging from 0 to 30 where higher scores represent better erectile function. | At 3 months post-surgery |
| Erectile Function as Assessed by the IIEF Questionnaire Erectile Function Domain |
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Inclusion Criteria:
Patient eligibility consists of men 40 to 65 years of age
Localized prostate cancer
Scheduled to undergo curative prostatectomy applying bilateral nerve-sparing procedure, with intact pre-surgical erectile function
International Index of Erectile Function-5 (IIEF-5) score of 22-25.
The patient has a sexual partner, of at least 6 months.
The patient's pre-surgical hematocrit is ≤ 48.
The patient is willing to attempt intercourse at least 5 times per month following recovery from surgery.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohamad E Allaf, MD | Johns Hopkins Hospital - Brady Urological Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29373284 | Background | Patel HD, Allaf ME. Erythropoietin to Enhance Recovery of Erectile Function in Men Following Radical Prostatectomy: The ERECT Trial. Eur Urol Focus. 2019 Jul;5(4):698-699. doi: 10.1016/j.euf.2018.01.002. Epub 2018 Jan 17. | |
| 16217394 | Background | Allaf ME, Hoke A, Burnett AL. Erythropoietin promotes the recovery of erectile function following cavernous nerve injury. J Urol. 2005 Nov;174(5):2060-4. doi: 10.1097/01.ju.0000176808.94610.dd. |
| Label | URL |
|---|---|
| The preoperative use of erythropoietin stimulating proteins prior to radical prostatectomy is not associated with increased cardiovascular or thromboembolic morbidity or mortality. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Erythropoietin (EPO) | 20,000 units of EPO given on the day before surgery, the day of surgery, and the day after surgery. Erythropoietin (EPO): Erythropoietin (EPO)-induced Protein 29, Human; 20,000 units subcutaneously given the day before surgery, day of surgery, and the day after surgery. |
| FG001 | Placebo | Placebo doses given the day before surgery, the day of surgery, and the day after surgery. Placebo: Saline injection (solution prepared by research pharmacy) subcutaneously given the day before surgery, day of surgery, and the day after surgery. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Erythropoietin (EPO) | 20,000 units of EPO given on the day before surgery, the day of surgery, and the day after surgery. Erythropoietin (EPO): Erythropoietin (EPO)-induced Protein 29, Human; 20,000 units subcutaneously given the day before surgery, day of surgery, and the day after surgery. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Erectile Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire Erectile Function Domain | Survey measuring erectile function using the IIEF (erectile function domain only) with overall score ranging from 0 to 30 where higher scores represent better erectile function. | Posted | Median | Inter-Quartile Range | score on a scale | At 6 months post-surgery |
|
1 year
Clavien-Dindo Complications (graded I, II, III, IV, and V) after surgery were assessed for all patients during hospitalization, at clinical follow-up visits, and via study survey follow-up. Clavien III or higher complications were considered serious.
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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 | Erythropoietin (EPO) | 20,000 units of EPO given on the day before surgery, the day of surgery, and the day after surgery. Erythropoietin (EPO): Erythropoietin (EPO)-induced Protein 29, Human; 20,000 units subcutaneously given the day before surgery, day of surgery, and the day after surgery. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Clavien III | Surgical and medical procedures | Systematic Assessment | Clavien III complication requiring procedure |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Clavien I-II | Surgical and medical procedures | Systematic Assessment | Clavien I-II complication |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Hiten Patel | Johns Hopkins Brady Urological Institute | 410-502-7710 | hiten.patel@lumc.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 | Mar 16, 2017 | Jul 27, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D004921 | Erythropoietin |
| ID | Term |
|---|---|
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
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| Erythropoietin (EPO) | Drug | Erythropoietin (EPO)-induced Protein 29, Human; 20,000 units subcutaneously given the day before surgery, day of surgery, and the day after surgery. |
|
Survey measuring erectile function using the IIEF (erectile function domain only) with overall score ranging from 0 to 30 where higher scores represent better erectile function. |
| At 9 months post-surgery |
| Erectile Function as Assessed by the IIEF Questionnaire Erectile Function Domain | Survey measuring erectile function using the IIEF (erectile function domain only) with overall score ranging from 0 to 30 where higher scores represent better erectile function. | At 12 months post-surgery |
| Patient Score on the Overall IIEF Questionnaire | Survey measuring erectile function using the IIEF (overall questionnaire) with overall score ranging from 0 to 75 where higher scores represent better erectile function. | At 3 months post-surgery |
| Patient Score on the Overall IIEF Questionnaire | Survey measuring erectile function using the IIEF (overall questionnaire) with overall score ranging from 0 to 75 where higher scores represent better erectile function. | At 6 months post-surgery |
| Patient Score on the Overall IIEF Questionnaire | Survey measuring erectile function using the IIEF (overall questionnaire) with overall score ranging from 0 to 75 where higher scores represent better erectile function. | At 9 months post-surgery |
| Patient Score on the Overall IIEF Questionnaire | Survey measuring erectile function using the IIEF (overall questionnaire) with overall score ranging from 0 to 75 where higher scores represent better erectile function. | At 12 months post-surgery |
| Patient Score on Health-related Quality of Life Questionnaires (SF-12 MCS) | Mental health composite score (MCS) component of the 12-Item Short Form Survey Instrument (SF-12) measured on a normalized scale with mean 50 and standard deviation 10 in the United States population. Higher scores represent a higher level of mental health. | At 3 months post-surgery |
| Patient Score on Health-related Quality of Life Questionnaires (SF-12 MCS) | Mental health composite score (MCS) component of the 12-Item Short Form Survey Instrument (SF-12) measured on a normalized scale with mean 50 and standard deviation 10 in the United States population. Higher scores represent a higher level of mental health. | At 6 months post-surgery |
| Patient Score on Health-related Quality of Life Questionnaires (SF-12 MCS) | Mental health composite score (MCS) component of the 12-Item Short Form Survey Instrument (SF-12) measured on a normalized scale with mean 50 and standard deviation 10 in the United States population. Higher scores represent a higher level of mental health. | At 9 months post-surgery |
| Patient Score on Health-related Quality of Life Questionnaires (SF-12 MCS) | Mental health composite score (MCS) component of the 12-Item Short Form Survey Instrument (SF-12) measured on a normalized scale with mean 50 and standard deviation 10 in the United States population. Higher scores represent a higher level of mental health. | At 12 months post-surgery |
| Patient Score on the Expanded Prostate Cancer Index Composite (EPIC) Sexual Domain | Sexual health domain score of the EPIC survey measuring health-related quality of life with higher scores representing better sexual function on a scale of 0 to 100. | At 3 months post-surgery |
| Patient Score on the Expanded Prostate Cancer Index Composite (EPIC) Sexual Domain | Sexual health domain score of the EPIC survey measuring health-related quality of life with higher scores representing better sexual function on a scale of 0 to 100. | At 6 months post-surgery |
| Patient Score on the Expanded Prostate Cancer Index Composite (EPIC) Sexual Domain | Sexual health domain score of the EPIC survey measuring health-related quality of life with higher scores representing better sexual function on a scale of 0 to 100. | At 9 months post-surgery |
| Patient Score on the Expanded Prostate Cancer Index Composite (EPIC) Sexual Domain | Sexual health domain score of the EPIC survey measuring health-related quality of life with higher scores representing better sexual function on a scale of 0 to 100. | At 12 months post-surgery |
| Patient Score on the Quality of Erection Questionnaire (QEQ) | Survey measuring quality of erections using the QEQ with an overall score range of 0 to 100 where higher scores represent better erection quality. | At 3 months post-surgery |
| Patient Score on the Quality of Erection Questionnaire (QEQ) | Survey measuring quality of erections using the QEQ with an overall score range of 0 to 100 where higher scores represent better erection quality. | At 6 months post-surgery |
| Patient Score on the Quality of Erection Questionnaire (QEQ) | Survey measuring quality of erections using the QEQ with an overall score range of 0 to 100 where higher scores represent better erection quality. | At 9 months post-surgery |
| Patient Score on the Quality of Erection Questionnaire (QEQ) | Survey measuring quality of erections using the QEQ with an overall score range of 0 to 100 where higher scores represent better erection quality. | At 12 months post-surgery |
| Hemoglobin Level at 2 Weeks After Surgery | Hemoglobin level at 2 weeks after surgery in grams per deciliter (g/dl). | 2 weeks after surgery |
| Number of Participants Requiring Transfusion During Hospitalization | Assess the number of participants requiring transfusion during hospitalization. | During hospital stay, up to 1 week |
| 17868418 | Background | Liu T, Allaf ME, Lagoda G, Burnett AL. Erythropoietin receptor expression in the human urogenital tract: immunolocalization in the prostate, neurovascular bundle and penis. BJU Int. 2007 Nov;100(5):1103-6. doi: 10.1111/j.1464-410X.2007.07194.x. Epub 2007 Sep 14. |
| 18778310 | Background | Burnett AL, Allaf ME, Bivalacqua TJ. Erythropoietin promotes erection recovery after nerve-sparing radical retropubic prostatectomy: a retrospective analysis. J Sex Med. 2008 Oct;5(10):2392-8. doi: 10.1111/j.1743-6109.2008.00980.x. Epub 2008 Sep 5. |
| 33530745 | Result | Patel HD, Schwen ZR, Campbell JD, Gorin MA, Partin AW, Burnett AL, Allaf ME. Effect of Erythropoietin on Erectile Function after Radical Prostatectomy: The ERECT Randomized Clinical Trial. J Urol. 2021 Jun;205(6):1681-1688. doi: 10.1097/JU.0000000000001586. Epub 2021 Feb 3. |
| Preoperative recombinant human erythropoietin injection versus preoperative autologous blood donation in patients undergoing radical retropubic prostatectomy. | View source |
| Placebo |
Placebo doses given the day before surgery, the day of surgery, and the day after surgery. Placebo: Saline injection (solution prepared by research pharmacy) subcutaneously given the day before surgery, day of surgery, and the day after surgery. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Placebo doses given the day before surgery, the day of surgery, and the day after surgery.
Placebo: Saline injection (solution prepared by research pharmacy) subcutaneously given the day before surgery, day of surgery, and the day after surgery.
|
|
| Secondary | Erectile Function as Assessed by the IIEF Questionnaire Erectile Function Domain | Survey measuring erectile function using the IIEF (erectile function domain only) with overall score ranging from 0 to 30 where higher scores represent better erectile function. | Posted | Median | Inter-Quartile Range | score on a scale | At 3 months post-surgery |
|
|
|
| Secondary | Erectile Function as Assessed by the IIEF Questionnaire Erectile Function Domain | Survey measuring erectile function using the IIEF (erectile function domain only) with overall score ranging from 0 to 30 where higher scores represent better erectile function. | Posted | Median | Inter-Quartile Range | score on a scale | At 9 months post-surgery |
|
|
|
| Secondary | Erectile Function as Assessed by the IIEF Questionnaire Erectile Function Domain | Survey measuring erectile function using the IIEF (erectile function domain only) with overall score ranging from 0 to 30 where higher scores represent better erectile function. | Posted | Median | Inter-Quartile Range | score on a scale | At 12 months post-surgery |
|
|
|
| Secondary | Patient Score on the Overall IIEF Questionnaire | Survey measuring erectile function using the IIEF (overall questionnaire) with overall score ranging from 0 to 75 where higher scores represent better erectile function. | Posted | Median | Inter-Quartile Range | score on a scale | At 3 months post-surgery |
|
|
|
| Secondary | Patient Score on the Overall IIEF Questionnaire | Survey measuring erectile function using the IIEF (overall questionnaire) with overall score ranging from 0 to 75 where higher scores represent better erectile function. | Posted | Median | Inter-Quartile Range | score on a scale | At 6 months post-surgery |
|
|
|
| Secondary | Patient Score on the Overall IIEF Questionnaire | Survey measuring erectile function using the IIEF (overall questionnaire) with overall score ranging from 0 to 75 where higher scores represent better erectile function. | Posted | Median | Inter-Quartile Range | score on a scale | At 9 months post-surgery |
|
|
|
| Secondary | Patient Score on the Overall IIEF Questionnaire | Survey measuring erectile function using the IIEF (overall questionnaire) with overall score ranging from 0 to 75 where higher scores represent better erectile function. | Posted | Median | Inter-Quartile Range | score on a scale | At 12 months post-surgery |
|
|
|
| Secondary | Patient Score on Health-related Quality of Life Questionnaires (SF-12 MCS) | Mental health composite score (MCS) component of the 12-Item Short Form Survey Instrument (SF-12) measured on a normalized scale with mean 50 and standard deviation 10 in the United States population. Higher scores represent a higher level of mental health. | Posted | Median | Inter-Quartile Range | score on a scale | At 3 months post-surgery |
|
|
|
| Secondary | Patient Score on Health-related Quality of Life Questionnaires (SF-12 MCS) | Mental health composite score (MCS) component of the 12-Item Short Form Survey Instrument (SF-12) measured on a normalized scale with mean 50 and standard deviation 10 in the United States population. Higher scores represent a higher level of mental health. | Posted | Median | Inter-Quartile Range | score on a scale | At 6 months post-surgery |
|
|
|
| Secondary | Patient Score on Health-related Quality of Life Questionnaires (SF-12 MCS) | Mental health composite score (MCS) component of the 12-Item Short Form Survey Instrument (SF-12) measured on a normalized scale with mean 50 and standard deviation 10 in the United States population. Higher scores represent a higher level of mental health. | Posted | Median | Inter-Quartile Range | score on a scale | At 9 months post-surgery |
|
|
|
| Secondary | Patient Score on Health-related Quality of Life Questionnaires (SF-12 MCS) | Mental health composite score (MCS) component of the 12-Item Short Form Survey Instrument (SF-12) measured on a normalized scale with mean 50 and standard deviation 10 in the United States population. Higher scores represent a higher level of mental health. | Posted | Median | Inter-Quartile Range | score on a scale | At 12 months post-surgery |
|
|
|
| Secondary | Patient Score on the Expanded Prostate Cancer Index Composite (EPIC) Sexual Domain | Sexual health domain score of the EPIC survey measuring health-related quality of life with higher scores representing better sexual function on a scale of 0 to 100. | Posted | Median | Inter-Quartile Range | score on a scale | At 3 months post-surgery |
|
|
|
| Secondary | Patient Score on the Expanded Prostate Cancer Index Composite (EPIC) Sexual Domain | Sexual health domain score of the EPIC survey measuring health-related quality of life with higher scores representing better sexual function on a scale of 0 to 100. | Posted | Median | Inter-Quartile Range | score on a scale | At 6 months post-surgery |
|
|
|
| Secondary | Patient Score on the Expanded Prostate Cancer Index Composite (EPIC) Sexual Domain | Sexual health domain score of the EPIC survey measuring health-related quality of life with higher scores representing better sexual function on a scale of 0 to 100. | Posted | Median | Inter-Quartile Range | score on a scale | At 9 months post-surgery |
|
|
|
| Secondary | Patient Score on the Expanded Prostate Cancer Index Composite (EPIC) Sexual Domain | Sexual health domain score of the EPIC survey measuring health-related quality of life with higher scores representing better sexual function on a scale of 0 to 100. | Posted | Median | Inter-Quartile Range | score on a scale | At 12 months post-surgery |
|
|
|
| Secondary | Patient Score on the Quality of Erection Questionnaire (QEQ) | Survey measuring quality of erections using the QEQ with an overall score range of 0 to 100 where higher scores represent better erection quality. | Posted | Median | Inter-Quartile Range | score on a scale | At 3 months post-surgery |
|
|
|
| Secondary | Patient Score on the Quality of Erection Questionnaire (QEQ) | Survey measuring quality of erections using the QEQ with an overall score range of 0 to 100 where higher scores represent better erection quality. | Posted | Median | Inter-Quartile Range | score on a scale | At 6 months post-surgery |
|
|
|
| Secondary | Patient Score on the Quality of Erection Questionnaire (QEQ) | Survey measuring quality of erections using the QEQ with an overall score range of 0 to 100 where higher scores represent better erection quality. | Posted | Median | Inter-Quartile Range | score on a scale | At 9 months post-surgery |
|
|
|
| Secondary | Patient Score on the Quality of Erection Questionnaire (QEQ) | Survey measuring quality of erections using the QEQ with an overall score range of 0 to 100 where higher scores represent better erection quality. | Posted | Median | Inter-Quartile Range | score on a scale | At 12 months post-surgery |
|
|
|
| Secondary | Hemoglobin Level at 2 Weeks After Surgery | Hemoglobin level at 2 weeks after surgery in grams per deciliter (g/dl). | Posted | Median | Inter-Quartile Range | g/dl | 2 weeks after surgery |
|
|
|
| Secondary | Number of Participants Requiring Transfusion During Hospitalization | Assess the number of participants requiring transfusion during hospitalization. | Posted | Count of Participants | Participants | During hospital stay, up to 1 week |
|
|
|
| 0 |
| 29 |
| 1 |
| 29 |
| 0 |
| 29 |
| EG001 | Placebo | Placebo doses given the day before surgery, the day of surgery, and the day after surgery. Placebo: Saline injection (solution prepared by research pharmacy) subcutaneously given the day before surgery, day of surgery, and the day after surgery. | 0 | 27 | 1 | 27 | 3 | 27 |
|
|
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
| D016298 |
| Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |