Prostate Cancer Clinical Trial
Official title:
Prospective, Controlled Study Evaluating Recovery of Potency and Continence Following Robot-Assisted Radical Prostatectomy With and Without Cryopreserved Umbilical Cord Allograft
This study aims at evaluating if placement of CLARIX® CORD 1K during robotic prostatectomy decreases the time to achieve complete erectile and urinary function after the surgery. As part of the study, the patient will be asked to answer various questions after the surgery regarding sexual and urinary function.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | October 1, 2025 |
Est. primary completion date | October 1, 2025 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 30 Years to 70 Years |
Eligibility | Inclusion Criteria: 1. Male aged between 30 and 70 years old 2. Primary diagnosis of organ confined prostate cancer 3. Scheduled to undergo bilateral, nerve-sparing RARP 4. Patient has ICIQ-SF score <6 5. Patient has no erectile dysfunction (defined as IIEF-6 score = 26) 6. Patient is willing to return for all visits as defined in the protocol 7. Patient is willing to follow the instruction of the Investigator 8. Patient has provided written informed consent Exclusion Criteria: 1. Previous history of pelvic radiation 2. Previous history of simple prostatectomy or transurethral prostate surgery 3. Previous history of systemic therapy for prostate cancer 4. Patient has neurogenic bladder 5. Body weight less than 50 kg (110 pounds) or a body mass index greater than 40 kg/m2 6. History of open pelvic surgery within 5 years except for hernia repair 7. Scheduled at the time of screening to undergo chemotherapy, radiation, hormone therapy, or open surgery during the study period. 8. Any neurologic disorder or psychiatric disorder (e.g., Parkinson's Multiple Sclerosis, etc.) that might confound postsurgical assessments 9. Received administration of an investigational drug within 30 days prior to study, and/or has planned administration of another investigational product or procedure during participation in this study 10. Previous history of anaphylaxis or hypersensitivity to liposomal amphotericin- B |
Country | Name | City | State |
---|---|---|---|
United States | Hackensack University Medical Center | Hackensack | New Jersey |
Lead Sponsor | Collaborator |
---|---|
Hackensack Meridian Health |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Erectile function | Erectile function will be evaluated using the International Index of Erectile Function (IIEF) | At three months post surgery | |
Primary | Erectile function | Erectile function will be evaluated using the International Index of Erectile Function (IIEF) | At six months post surgery | |
Primary | Erectile function | Erectile function will be evaluated using the International Index of Erectile Function (IIEF) | At twelve months post surgery | |
Secondary | Potency endpoint | IIEF-6 Levels at 6 weeks post-op between the two treatment groups | 6 weeks post op | |
Secondary | Potency endpoint | IIEF-6 Levels at 3 months post-op between the two treatment groups | 3 months post op | |
Secondary | Potency endpoint | IIEF-6 Levels at 6 months post-op between the two treatment groups | 6 months post op | |
Secondary | Potency endpoint | IIEF-6 Levels at 12 months post-op between the two treatment groups | 12 months post op | |
Secondary | Return to continence | Continence will be evaluated using the International Consultation of Incontinence Questionnaire - Short Form (ICIQ-SF) | At 6 weeks post surgery | |
Secondary | Return to continence | Continence will be evaluated using the International Consultation of Incontinence Questionnaire - Short Form (ICIQ-SF) | At three months post surgery | |
Secondary | Return to continence | Continence will be evaluated using the International Consultation of Incontinence Questionnaire - Short Form (ICIQ-SF) | At six months post surgery | |
Secondary | Return to continence | Continence will be evaluated using the International Consultation of Incontinence Questionnaire - Short Form (ICIQ-SF) | At twelve months post surgery | |
Secondary | Pad Weight | Changes from baseline of average pad weight to 6 weeks post-op between treatment groups | 6 weeks post op | |
Secondary | Pad Count | Proportion of patients that wear 0 or 1 safety pads; 1-2 safety pads; and >2 safety pads per day | 6 weeks post op | |
Secondary | Pad Weight | Changes from baseline of average pad weight to 3 months post-op between treatment groups | 3 months post op | |
Secondary | Pad Count | Proportion of patients that wear 0 or 1 safety pads; 1-2 safety pads; and >2 safety pads per day | 3 months post op | |
Secondary | Pad Weight | Changes from baseline of average pad weight to 6 months post-op between treatment groups | 6 months post op | |
Secondary | Pad Count | Proportion of patients that wear 0 or 1 safety pads; 1-2 safety pads; and >2 safety pads per day | 6 months post op | |
Secondary | Pad Weight | Changes from baseline of average pad weight to 12 months post-op between treatment groups | 12 months post op | |
Secondary | Pad Count | Proportion of patients that wear 0 or 1 safety pads; 1-2 safety pads; and >2 safety pads per day | 12 months post op | |
Secondary | Sexual encounter | Patients will be asked to complete the Sexual Encounter Profile (SEP) Diary to document after each sexual attempt | At three months post surgery | |
Secondary | Sexual encounter | Patients will be asked to complete the Sexual Encounter Profile (SEP) Diary to document after each sexual attempt | At six months post surgery | |
Secondary | Sexual encounter | Patients will be asked to complete the Sexual Encounter Profile (SEP) Diary to document after each sexual attempt | At twelve months post surgery | |
Secondary | Biochemical recurrence endpoint | Proportion of patients with biochemical recurrence at 6 weeks post-op between groups. | 6 weeks post-op | |
Secondary | Biochemical recurrence endpoint | Proportion of patients with biochemical recurrence at 3 months post-op between groups. | 3 months post-op | |
Secondary | Biochemical recurrence endpoint | Proportion of patients with biochemical recurrence at 6 months post-op between groups. | 6 months post-op | |
Secondary | Biochemical recurrence endpoint | Proportion of patients with biochemical recurrence at 12 months post-op between groups. | 12 months post-op | |
Secondary | Patient intercourse satisfaction endpoint | Patient satisfaction using Likert score at 6 weeks post-op between groups | 6 weeks post op | |
Secondary | Patient intercourse satisfaction endpoint | Patient satisfaction using Likert score at 3 months post-op between groups | 3 months post op | |
Secondary | Patient intercourse satisfaction endpoint | Patient satisfaction using Likert score at 6 months post-op between groups | 6 months post op | |
Secondary | Patient intercourse satisfaction endpoint | Patient satisfaction using Likert score at 12 months post-op between groups | 12 months post op | |
Secondary | Failure Events of Following RARP endpoint | Incidence of readmission for hospital stay at 2 weeks post-op between groups. | 2 weeks post-op | |
Secondary | Failure Events of Following RARP endpoint | Number of surgical interventions at 2 weeks post-op between groups | 2 weeks post-op |
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