[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"radical-prostatectomy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:radical-prostatectomy":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,42,73,106,136,165],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100522672","phase-1-a-pilot-presurgical-trial-of-regn5678-anti-psma-x-cd28-in-patients-with-high-risk-localized-prostate-cancer-followed-by-radical-prostatectomy-100522672",false,"NCT06085664","A Pilot Presurgical Trial of REGN5678 (Anti-PSMA x CD28) in Patients With High-risk, Localized Prostate Cancer Followed by Radical Prostatectomy","A Pilot Presurgical Trial of REGN5678 (Anti-PSMA X CD28) in Patients With High-Risk, Localized Prostate Cancer Followed by Radical Prostatectomy","Inclusion Criteria:\n\n* Men ≥ 18 years of age\n* Histologically documented Gleason 8 or greater prostatic adenocarcinoma in at least 3 biopsy cores and at least 8 mm of disease on a single core of Gleason 8 or greater. Prostate biopsy within 3 months of screening is allowed for entry requirements. Prostate biopsy must be reviewed at MD Anderson Cancer Center. Patients with small cell, neuroendocrine, or transitional cell carcinomas or mixed histologies are not eligible\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) grade of 0 or 1\n* No evidence of metastatic disease as documented by technetium-99m (99mTc) bone scan and by computed tomography (CT) or magnetic resonance imaging (MRI) scans. Imaging may be obtained up to 60 days prior to enrollment\n* Localized or locally advanced disease deemed by the surgeon to be resectable. Patients must be appropriate candidates for radical prostatectomy plus pelvic lymph node dissection\n* No prior treatment for prostate cancer including prior surgery (excluding transurethral resection of the prostate \\[TURP\\]), cryoablation, pelvic lymph node dissection, radiation therapy, hormonal therapy or chemotherapy\n* Hemoglobin ≥ 11 g\u002FdL\n* Absolute neutrophil count ≥ 1.5 x 10\\^9\u002FL\n* Platelet count ≥ 100 x 10\\^9\u002FL\n* Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or estimated glomerular filtration rate \\> 50 mL\u002Fmin\u002F1.73 m\\^2. A 24-hour urine creatinine collection may substitute for the calculated creatinine clearance to meet eligibility criteria\n* Total bilirubin ≤ 1.5 x ULN\n\n  * NOTES: Patients with Gilbert's syndrome do not need to meet total bilirubin requirements provided their total bilirubin is not greater than their historical level. Gilbert's syndrome must be documented appropriately as past medical history\n* Aspartate aminotransferase (AST) ≤ 2.5 x ULN\n* Alanine aminotransferase (ALT) ≤ 2.5 x ULN\n* Alkaline phosphatase (ALP) ≤ 2.5 x ULN\n* Consent to MD Anderson laboratory protocol PA13-0291\n* Willing and able to comply with clinic visits and study-related procedures\n* Provide informed consent signed by study patient\n* To avoid risk of drug exposure through the ejaculate (even men with vasectomies), subjects must use a condom during sexual activity while on study drug and for 3 months following the last dose of study drug. If the subject is engaged in sexual activity with a woman of childbearing potential, a condom is required along with another effective contraceptive method consistent with local regulations regarding the use of birth control methods for subjects participating in clinical studies and their partners. Donation of sperm is not allowed while on study drug and for 3 months following the last dose of study drug\n\nExclusion Criteria:\n\n* Prior hormone therapy for prostate cancer including orchiectomy, antiandrogens, ketoconazole, or estrogens (5-alpha reductase inhibitors allowed), or luteinizing hormone-releasing hormone (LHRH) agonists\u002Fantagonists\n* Currently enrolled in another interventional study\n* Concurrent treatment with systemic corticosteroids (prednisone dose \\> 10 mg per day or equivalent) or other immunosuppressive drugs \\\u003C 14 days prior to treatment initiation. Steroids that are topical, inhaled, nasal (spray), or ophthalmic solution are permitted\n* History of or known or suspected autoimmune disease (exception\\[s\\]: subjects with vitiligo, resolved childhood atopic dermatitis, hypothyroidism, or hyperthyroidism that is clinically euthyroid at screening are allowed)\n* Known evidence of an active infection requiring systemic therapy such as human immunodeficiency virus (HIV), active hepatitis, or fungal infection. Patients with known HIV infection which is well-controlled (undetectable viral load by HIV ribonuclecid acid \\[RNA\\] polymerase chain reaction \\[PCR\\]) and CD4 counts greater than 350 are permitted to participate\n* History of clinically significant cardiovascular disease including, but not limited to:\n\n  * Myocardial infarction or unstable angina ≤ 6 months prior to treatment initiation\n  * Clinically significant cardiac arrhythmia\n  * Deep vein thrombosis, pulmonary embolism, stroke ≤ 6 months prior to treatment initiation\n  * Congestive heart failure (New York Heart Association class III-IV)\n  * Pericarditis\u002Fclinically significant pericardial effusion\n  * Myocarditis\n  * Endocarditis\n* History of major implant(s) or device(s), including but not limited to:\n\n  * Prosthetic heart valve(s)\n  * Artificial joints and prosthetics placed ≤ 12 months prior to treatment initiation\n  * Current or prior history of infection or other clinically significant adverse event associated with an exogenous implant or device that cannot be removed\n* Other prior malignancy (exceptions: adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or any other cancer in situ currently in complete remission) ≤ 2 years prior to enrollment\n* Has received major surgery within 14 days of first administration of study drug\n* Encephalitis, meningitis, neurodegenerative disease (with the exception of mild dementia that does not interfere with activities of daily living \\[ADLs\\]) or uncontrolled seizures in the year prior to first dose of study therapy\n* Known history of, or any evidence of interstitial lung disease, or active, non-infectious pneumonitis (past 5 years)\n* Receipt of a live vaccine within 4 weeks of planned start of study medication\n* Prior allogeneic stem cell transplantation or recipients of organ transplants at any time, or autologous stem cell transplantation within 12 weeks of the start of study treatment\n* Any medical, psychological or social condition that in the opinion of the investigator, would preclude participation in this study","MALE","18 Years",{"count":19,"type":20},42,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","To learn about the safety and effects of a drug called REGN5678 when it is given to patients with high-risk prostate cancer.",[27,28],"Prostate Cancer","Radical Prostatectomy","RECRUITING","2026-07-01",{"date":32,"type":33},"2026-07-02","ACTUAL",{"date":35,"type":33},"2023-12-04",{"date":37,"type":20},"2028-06-30",{"name":39,"class":40},"M.D. Anderson Cancer Center","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":53,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":72},"100583227","phase-3-pivotal-study-of-voro-urologic-scaffold-100583227","NCT06873581","Pivotal Study of Voro Urologic Scaffold","A Pivotal Study of Voro Urologic Scaffold for the Treatment of Post Prostatectomy Stress Urinary Incontinence (ARID II)","ARID II","Inclusion Criteria:\n\n1. Male \\>= 45 years of age of any race and ethnic group\n2. Diagnosed with prostate cancer and scheduled for radical prostatectomy\n3. Gleason Grade Group 4 or lower\n4. Prostate size less than 80 grams, as measured by Magnetic Resonance Imaging (MRI)\n5. Able and willing to provide written consent to participate in the study\n6. Able and willing to comply with study follow-up visits and procedures\n7. Willing to forego any other procedures for stress urinary incontinence (SUI) during the study\n\nExclusion Criteria:\n\n1. Malignant tumors with known bladder neck or urethral sphincter invasion or metastatic disease confirmed via baseline assessments (example \\[e.g.,\\] Multiparametric magnetic resonance imaging \\[mpMRI\\], bone scan)\n2. History of urinary incontinence, including stress or urge urinary incontinence\n3. Demonstration of SUI, such as positive 1 hour pad weight test or participant reported incontinence episodes\n4. Currently treated with medications to treat overactive bladder (OAB)\n5. Post void residual \\>200 milliliter (ml) or \\> 25 percentage (%) total volume(= voided volume + residual volume)\n6. Presence of urethral stricture or bladder neck contracture\n7. History of urethral stricture\n8. Current or chronic urinary tract infection\n9. Prior urologic outlet surgical or minimally invasive procedure (e.g., Transurethral resection of the prostate \\[TURP\\], Holmium laser enucleation of the prostate \\[HoLEP,\\] Rezum, etc.).\n10. Prior pelvic radiation or anticipated need for radiation after radical prostatectomy\n11. History of neurogenic lower urinary tract dysfunction\n12. History or current need for intermittent urinary catheterization\n13. Body mass index \\>40\n14. History of cancer (excluding prostate cancer meeting the inclusion criteria) which is not considered in complete 5 year remission (excluding squamous and basal cell skin carcinoma)\n15. History of bladder malignancy\n16. Diagnosed or suspected primary neurologic conditions known to affect voiding function\n17. History of clinically significant congestive heart failure (i.e., New York Heart Association \\[NYHA\\] Class III and IV)\n18. Current uncontrolled diabetes (i.e., hemoglobin A1c \\[glycated hemoglobin or glycosylated hemoglobin\\] \\>=7.5%)\n19. Current overactive bladder defined as a score of \\> 8 on the Overactive Bladder Questionnaire (OAB-8) administered at the baseline visit\n20. History of immunosuppressive conditions or on medications which modulate the immune system\n21. Any significant medical history that would pose an unreasonable risk or make the participant unsuitable for the study per investigator discretion\n22. Participant with planned concomitant surgery\n23. Anterior fascial sparing radical prostatectomy\n24. Retzius sparing radical prostatectomy\n25. Participant currently participating in other investigational studies unless approved by the Sponsor in writing\n26. Participant is, in the investigator's judgement, part of a vulnerable population, including but not limited to:\n\n    1. Prisoners\n    2. Individuals pending incarceration\n    3. Individuals experiencing any cognitive or psychiatric condition that interferes with or precludes direct and accurate communication with the study investigator regarding the study or affects the ability to complete the study quality of life questionnaires\n27. Planned adjuvant radiation therapy","45 Years",{"count":52,"type":20},266,[54],"PHASE3","The objective of this study is to compare safety and effectiveness of the Voro Urologic Scaffold in adult men undergoing robotic assisted radical prostatectomy as compared to control arm.\n\nThe study is a multi-center, single blind, randomized, controlled trial. Up to 266 participants will be treated at up to 30 centers in the United States. The study will consist of a Baseline visit, implantation during robotic assisted radical prostatectomy (RARP), catheter removal, 6 weeks, 6 months, 12 months, 18 months, and 24 months.",[28,57],"Stress Urinary Incontinence (SUI)",[59,28,60,48,61],"SUI","Voro Urologic Scaffold","Post-prostatectomy incontinence","2026-06-21",{"date":64,"type":33},"2026-06-23",{"date":66,"type":33},"2025-04-18",{"date":68,"type":20},"2028-04-30",{"name":70,"class":71},"Levee Medical, Inc.","INDUSTRY",19,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":81,"enrollmentInfo":82,"targetDuration":4,"studyType":84,"phases":4,"briefSummary":85,"conditions":86,"keywords":90,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":41},"100641019","everist-impact-of-image-detected-accessory-pudendal-artery-on-erection-recovery-after-nerve-sparing-prostatectomy-100641019","NCT07597798","EVERiST: Impact of Image Detected Accessory Pudendal Artery on Erection Recovery After Nerve Sparing Prostatectomy","EVERiST: Erectile Function Recovery After Bilateral neuroVascular Bundle Sparing Robot Assisted Radical prostatEctomy in Patients With or Without an Accessory Pudendal aRtery Detected on diagnoSTic Multiparametric MRI: A Feasibility Study","EVERiST","Inclusion Criteria:\n\n* Men diagnosed with cT2-T3a N0 M0 PCa aged between 18 and 79 from all ethnic backgrounds.\n* Patients who underwent a prostate mpMRI before prostate biopsy.\n* Medically fit to undergo RARP.\n* Diagnostic quality prostate biopsies concordant with a diagnostic quality prostate mpMRI adequate to provide a surgical plan.\n* Scheduled for RARP with a recommendation of NVB spare based on multidisciplinary meetings informed by mpMRI, biopsy result and clinical factors.\n* Sexually active men with no to mild ED at baseline based on IIEF-EFD (\\>=24) questionnaire.\n* Preference to preserve erectile function for sexual intercourse.\n* Ability to read English sufficiently to understand PIS and able to give informed consent.\n\nExclusion Criteria:\n\n* Established moderate\u002F severe ED (IIEF-EFD \\\u003C24)\n* Patients who received neo-adjuvant androgen deprivation therapy.\n* Patients with previous surgery for benign prostatic enlargement\n* Patients who received previous treatment for prostate cancer: External beam radiotherapy, brachytherapy, focal therapy, chemotherapy.\n* Previous pelvic or penile fracture\n* Previous surgery for ED\n* Poor quality prostate mpMRI or biparametric MRI (no contrast)\n* Established vascular disease (ischaemic heart disease, cerebrovascular disease, peripheral vascular disease)","79 Years",{"count":83,"type":20},40,"OBSERVATIONAL","Prostate cancer is the most common cancer amongst men in the United Kingdom, and two common curative treatments are surgery to remove the prostate (radical prostatectomy) or radiotherapy. Both treatments can affect quality of life, mainly because of problems with erections and urinary leakage. Many men feel disappointed or regret their treatment choice because of changes in their sexual function. Surgeons often use a 'nerve-sparing' technique to reduce the risk of erectile dysfunction (ED), but many men still experience erection problems afterwards. A way to improve erectile function recovery after surgery further would be to identify accessory (additional) arteries to the penis. Up to one in three men have an extra artery called the accessory pudendal artery (APA). Preserving this artery during surgery may improve recovery of erections by protecting blood flow and reducing the risk or severity of ED. Until recently, surgeons could only try to see these arteries during the operation, and no study has tested whether they are preserved or whether this makes a difference. This has changed with the advent of imaging. Men already have an advanced MRI scan (called a multiparametric MRI) before prostate cancer treatment. These scans can also show whether an APA is present. In addition, robotic surgery, now the gold standard for radical prostatectomy, allows operations to be video recorded. This allows comparison of what was seen on the scan with what happened during surgery and then monitoring of recovery afterwards. Early research suggests that men with an APA have better erections before surgery. This study will test whether preserving the APA during surgery helps erections recover afterwards.\n\nIn this first phase of the research (Phase 1), a feasibility study will be carried out at University College London Hospital. The study will invite 20-40 men with good sexual function before surgery, who are having robotic prostatectomy with a nerve-sparing approach. Multiparametric MRI scans will be used to identify whether an APA is present and video recordings will be collected to see if the artery was preserved. Participants will complete simple questionnaires on erections and quality of life before and after surgery up to 1 year. To assess whether the artery was preserved, an extra MRI scan will be organised after surgery for those with an APA, as well as penile ultrasound to assess erectile machinery. Ethical approval has already been obtained from the regulatory bodies, and the study is ready to start recruiting participants.\n\nThe results will allow planning of a larger, national study (Phase 2). That study will test whether preserving the APA improves erectile recovery, reduces the severity of ED, and improves quality of life. If confirmed, this research could lead to modification in surgical approach, more personalised counselling before surgery, and reduced long-term need for costly ED treatments within the NHS.",[28,87,88,89],"Erectile Dysfunction Following Radical Prostatectomy","Erectile Dysfunction Due to Arterial Insufficiency","Robotic Radical Prostatectomy",[91,92,93,94,95,96],"ED post RARP","Prostate Cancer Survivorship","Erectile dysfunction","Radical prostatectomy","Accessory pudendal artery","APA","2026-05-13",{"date":99,"type":33},"2026-05-19",{"date":101,"type":33},"2026-01-15",{"date":103,"type":20},"2028-01-15",{"name":105,"class":40},"University College, London",{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":113,"targetDuration":115,"studyType":84,"phases":4,"briefSummary":116,"conditions":117,"keywords":122,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":41},"100632684","prognostic-value-of-early-postoperative-prostate-specific-antigen-for-oncological-outcomes-after-radical-prostatectomy-100632684","NCT07516886","Prognostic Value of Early Postoperative Prostate-Specific Antigen for Oncological Outcomes After Radical Prostatectomy","PPSARP","Inclusion Criteria:\n\n* Patient is an adult biological male.\n* Patient has morphologically confirmed and untreated prostate cancer.\n* Patient who will be treated with open, laparoscopic or robot-assisted laparoscopic radical prostatectomy.\n* Patient is informed about this observational study and has signed the informed consent form.\n\nExclusion Criteria:\n\n* Patient has radiologically of morphologically confirmed prostate cancer metastases before the operation.\n* Patient received neoadjuvant prostate cancer treatment.\n* Patient is set to receive adjuvant treatment.\n* Patient has any contraindications for the operation.",{"count":114,"type":20},500,"10 Years","This prospective observational study aims to evaluate the prognostic significance of early postoperative prostate-specific antigen (PSA) levels in patients undergoing radical prostatectomy for prostate cancer.\n\nNo investigational interventions will be performed. All diagnostic procedures, follow-up assessments, and treatments will be conducted in accordance with standard clinical practice and established prostate cancer management guidelines. Participation in the study will not influence treatment decisions.",[118,119,120,121,28],"Prostate Cancer (Post Prostatectomy)","Prostate Cancer (Adenocarcinoma)","Prostate Cancer (Diagnosis)","Prostate Specific Antigen",[123,124,125,126],"prostate cancer","persistent prostate-specific antigen","prostate-specific antigen","radical prostatectomy","2026-04-01",{"date":129,"type":33},"2026-04-08",{"date":131,"type":33},"2024-01-22",{"date":133,"type":20},"2039-07",{"name":135,"class":40},"Lithuanian University of Health Sciences",{"id":137,"slug":138,"hasResults":11,"nctId":139,"briefTitle":140,"officialTitle":140,"acronym":141,"eligibilityCriteria":142,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":143,"targetDuration":4,"studyType":21,"phases":145,"briefSummary":147,"conditions":148,"keywords":151,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":41},"100625763","pre-operative-nurse-led-education-with-direct-physiotherapy-referral-to-reduce-post-prostatectomy-incontinence-100625763","NCT07426861","Pre-Operative Nurse-Led Education With Direct Physiotherapy Referral to Reduce Post-Prostatectomy Incontinence","PRO-ACT","Inclusion Criteria:\n\nMale patients aged ≥ 18 years Diagnosis of prostate cancer Scheduled for radical prostatectomy (open, laparoscopic, or robotic-assisted) Able to provide written informed consent\n\nExclusion Criteria:\n\nPre-existing urinary incontinence requiring pad use Prior pelvic radiotherapy Prior prostate surgery affecting continence outcomes Medical contraindication to participation in pelvic floor physiotherapy\n\nInability to provide informed consent",{"count":144,"type":20},80,[146],"NA","Urinary incontinence is a common complication following radical prostatectomy and can significantly impact quality of life. Pelvic floor physiotherapy is recommended to reduce post-operative incontinence; however, referral pathways and patient engagement vary.\n\nThe PRO-ACT trial is a single-centre, parallel-group randomised controlled trial evaluating whether a structured pre-operative education bundle combined with direct physiotherapy referral reduces urinary incontinence following radical prostatectomy compared to standard care.\n\nEligible men undergoing radical prostatectomy at Beaumont Hospital will be randomised 1:1 to either:\n\nStandard of care (educational video and recommendation for physiotherapy with patient-initiated referral), or\n\nA structured pre-operative intervention including a one-to-one ANP-led education session, scheduled post-operative follow-up call, and direct referral to supervised pelvic floor physiotherapy.\n\nThe primary outcome is mean urinary pad usage per 24 hours at 3 months post-operatively. Secondary outcomes include time to continence, quality of life, physiotherapy adherence, and postoperative complication rates.",[27,149,150,28],"Urinary Incontinence","Postoperative Complications",[152,153,154,155],"Pelvic Floor Physiotherapy","Preoperative Education","Post-Prostatectomy Incontinence","Continence Recovery","2026-02-16",{"date":158,"type":33},"2026-02-23",{"date":160,"type":33},"2025-12-20",{"date":162,"type":20},"2028-12-31",{"name":164,"class":40},"Royal College of Surgeons, Ireland",{"id":166,"slug":167,"hasResults":11,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":4,"eligibilityCriteria":171,"healthyVolunteers":11,"sex":16,"minAge":172,"maxAge":173,"enrollmentInfo":174,"targetDuration":4,"studyType":21,"phases":176,"briefSummary":177,"conditions":178,"keywords":180,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":41},"100482129","phase-2-safety-and-efficacy-evaluation-of-bz371a-topically-applied-on-prostatectomized-patients-100482129","NCT05558007","Safety and Efficacy Evaluation of BZ371A Topically Applied on Prostatectomized Patients","Phase 2 Clinical Trial to Evaluate Safety and Efficacy of BZ371A in a Gel Applied in Patients That Performed Radical Prostatectomy","Inclusion Criteria:\n\n1. Men between the ages of 40 and 65 years;\n2. Exclusive heterosexual men, regardless of race or social class.\n3. RP due to prostate cancer without metastasis;\n4. RP performed less than 60 days before the screening visit;\n5. Erectile function prior to normal RP, defined as IIEF questionnaire with more than 22 points in domain A;\n6. Stable sexual partner (more than 2 months prior to RP), and intention to maintain the relationship during the study.\n7. Continuous use of 5mg Tadalafil from the 30th up to the 60th day after RP.\n\nExclusion Criteria:\n\n1. Prostate cancer in TNM stage classified as T3 or T4.\n2. Perineal and\u002For open RP;\n3. Necessity of other therapy for prostate cancer than RP, including radiation therapy or hormone therapy;\n4. Uncontrolled diabetes at screening visit (HbA1C \\> 10%);\n5. Prior spinal cord injury with lower limb paralysis;\n6. Current male hormone use, or hypogonadism, defined by total testosterone below 8 nmol\u002FL (2300 pg\u002FmL) or total testosterone between 8 and 11 nmol\u002FL (2300 and 3170 pg\u002FmL) and free testosterone \\\u003C 220 pmol\u002FL (\\\u003C 64 ng\u002FdL);\n7. Patients with current depression, characterized by use or need for use of antidepressants.\n8. Presence of genital lesions (such as severe penile fibrosis or Peyronie's disease) or active sexually transmitted disease (STD) (such as herpes, gonorrhea, candidiasis, HPV, and others) that impair analysis of local adverse effects on the genitalia;\n9. Use of topical medications in the genital region that may interfere in the IP evaluation, as well as in its absorption or drug interaction;\n10. Possession of penile prosthesis;\n11. History of symptomatic hypotension, or diseases that increase the risk of symptomatic hypotension, such as patient with heart diseases (including history of angina and\u002For heart failure) and nephropathies;\n12. Current use of nitrates, such as propatilnitrate (Sustrate®), isosorbide (Monocordil®, Cincordil®, Isordil®), nitroglycerin (Nitradisc®, Nitroderm TTS®, Nitronal®, Tridil®) and isosorbitol dinitrate (Isocord®);ketoconazole; ritonavir; and rifampicin.\n13. Findings on ECG and\u002For laboratory tests that, in the Investigator's criteria, are considered significant and offer risk to the research volunteer's participation or may hinder the study analyses;\n14. BP outside the limits considered safe: SBP below 90 mmHg or above 170 mmHg; or DBP below 50 mmHg or above 100 mmHg, except situations such as \"white coat syndrome\";\n15. Diseases that can cause priapism, such as sickle cell anemia, multiple myeloma, or leukemia;\n16. Histroy of priapism, defined as painful erection from up to 6 hours.\n17. Current relevant diarrhea, defined as duration over four weeks, association with abdominal pain or dysabsortive syndrome, or presence of mucus, pus, or blood in the stool;\n18. Known hypersensitivity to tadalafil and\u002For BZ371A;\n19. History of symptomatic Lactose intolorence such as: the necessity of enzymatic treatment, abdominal distension or diarrhea when ingesting products or supplements with lactose;\n20. Low adhsesion to 5mg Tadalafil use, characterized by the use of \\\u003C80% of the pills between the 30th and 60th day post PR;.\n21. Pregnant or lacting partner.\n22. Partner in childbearing age which does not accept to get exposed to the treatment\n23. Any disease, condition or physical finding that the Investigator considers significant and that increases the risk of the research subject's participation or may interfere with the results, including severe debilitating illness, presence of cancer other than prostate cancer, severe mental illness persistent medication abuse;","40 Years","65 Years",{"count":175,"type":20},72,[24],"To determine efficacy, safety and tolerabiltiy of topically applied BZ371A in patients that experienced RP, in combination with daily tadalafil compared to placebo.",[87,179,27,28],"Erectile Dysfunction",[179,28,27],"2024-10-18",{"date":183,"type":33},"2024-10-22",{"date":185,"type":33},"2023-11-22",{"date":187,"type":20},"2025-01-31",{"name":189,"class":71},"Biozeus Biopharmaceutical S.A."]