Peyronie's Disease

Researchers are studying men with metastatic castration-resistant prostate cancer (mCRPC) to understand how different PET/CT scans can predict outcomes during radioligand therapy with 177Lu-PSMA-617. This is an exploratory, prospective study conducted at a single center, focusing on imaging tumor heterogeneity to help assess therapy effects and patient response. The study is designed specifically for Veterans undergoing this treatment. Participants will receive several types of PET/CT scans at different times: before starting LuPSMA radioligand therapy (RLT), and then after the 2nd, 4th, and 6th treatment cycles. These scans include 18F-Fluciclovine PET/CT (Axumin), 18F-DCFPyL PET/CT, and 18F-FDG PET/CT. The 18F-Fluciclovine scans will be performed within seven days of the PSMA PET scans to compare imaging results at each time point. During the study, detailed imaging measures such as lesion uptake and tumor volume will be collected and analyzed over time. Patients will be followed at the institution to correlate these imaging results with clinical outcomes. The main outcome measured is the impact of 18F-Fluciclovine PET/CT on predicting outcomes of the 177Lu-PSMA-617 therapy from enrollment through 34 weeks of treatment.

Researchers are evaluating the effectiveness of induction chemo-immunotherapy in adult men with locoregionally advanced squamous cell carcinoma of the penis that is suitable for surgical removal. This phase II trial includes patients with specific nodal involvement or lymph node recurrence, some with limited distant metastases that can be locally treated. The study aims to assess the pathological complete response after treatment and investigate correlations with tumor markers and quality of life. Participants will receive three 21-day cycles of chemotherapy with carboplatin and paclitaxel, combined with two doses of pembrolizumab during the first and third cycles. After completing induction therapy, a CT scan will evaluate response, followed by surgical removal of visible or suspected tumors within 3 to 9 weeks. Subsequently, patients enter an adjuvant phase with up to seven cycles of pembrolizumab every 6 weeks. Treatment monitoring includes physical exams, adverse event tracking, and blood tests before each cycle. Throughout the study, disease status will be monitored by CT scans at several intervals up to 24 months after surgery, followed by standard follow-up visits every 6 months. Quality of life will be assessed using questionnaires at multiple time points during the first two years. The primary outcome is the pathological complete response immediately after surgery, with secondary outcomes including treatment toxicity, progression-free and overall survival at two years, and correlations between clinical outcomes and tumor characteristics.

Researchers are studying Peyronie's Disease and erectile dysfunction to find out if combining low-intensity shockwave therapy (LiSWT) with Xiaflex (Collagenase Clostridium Histolyticum) injections improves the curvature of the penis better than Xiaflex injections alone. The trial aims to compare these treatments in men with stable symptoms and specific curvature measurements. This randomized study is sponsored by Mayo Clinic and focuses on clinical outcomes related to symptom bother, sexual intercourse ability, and erectile function. Participants will be randomly assigned to one of two groups. One group will receive eight Xiaflex injections divided into four series, with two injections each, spaced 1 to 7 days apart, combined with four sessions of low-intensity shockwave therapy given before each injection series. The other group will receive the Xiaflex injections alone as per standard care without shockwave therapy. The shockwave therapy involves delivering 1,500 shocks at a set rate and power using a specialized device. During the study, participants will be evaluated at the start and after six weeks for changes in symptom bother, ability to have penetrative sexual intercourse, need for surgical straightening, and erectile function measured by the International Index of Erectile Function (IIEF-EF). Researchers will monitor responses to treatment using physical assessments and questionnaires. The total duration of participation covers the injection series and follow-up assessments to track improvements and safety.

This research aims to evaluate a step-wise treatment protocol using collagenase Clostridium histolyticum (CCH) injections for men with Peyronie's Disease who have not responded to initial treatments. The study focuses on a modified injection technique with limited in-office modeling, assessing safety and effectiveness compared to previous data. It also involves sexual partners who will provide feedback on their support during treatment. Participants will receive up to four series of CCH injections administered on back-to-back days, with a total dose of 0.9 mg per series diluted to 0.8 mL. Mild in-office modeling is performed on the second treatment day of each series, along with wrap applications to reduce bruising. Men will take sildenafil 25 mg nightly starting on treatment day 2 and use Restorex daily beginning post-injection day 3, continuing both until six weeks after the final injection. If patients are not satisfied after four series, they may enter a salvage phase 9-12 months later, receiving up to two additional series with more aggressive modeling. During the study, participants and their partners will complete questionnaires at baseline, before each series, six weeks after the fourth series, and one year after the final injection. Researchers will measure penile curvature and length at one year, along with therapy adherence, satisfaction, adverse events, and partner support. The total study duration extends to one year post-treatment, with ongoing safety and efficacy monitoring throughout.

Researchers are evaluating the effectiveness of extracorporeal shock wave therapy in treating Peyronie's disease, a condition affecting the penis. This single-center, prospective clinical trial focuses on patients diagnosed with stable stage Peyronie's disease, meaning the condition has not worsened in pain or curvature for at least six months. The study is conducted by Uskudar University and aims to compare shock wave therapy with routine pharmacological treatment. Participants will be randomly assigned to one of two groups: one receiving standard pharmacological treatment without special intervention, and the other undergoing Extracorporeal Shockwave Therapy. The therapy involves eight treatment sessions, each delivering 3000 pulses at 2.5 bar pressure and 15 Hz frequency twice a week using a radial shockwave device. The shock waves target the penile plaque area through gel application on the penile shaft. Before and after treatment, participants will complete assessments including the International Erectile Function Index-5 and the Quality of Life Questionnaire short form to evaluate erectile function and quality of life. These outcomes will be measured at 5 weeks. The study monitors adherence and collects data to statistically analyze the therapy's impact on erectile function and quality of life over the study period.

Researchers are evaluating the safety and clinical response of a combined treatment using non-ablative radiofrequency and low-intensity shock wave therapy in men with Peyronie's disease. This one-arm clinical trial aims to determine if this treatment is safe and whether it improves symptoms such as sexual function, pain, and penile erection. The study also explores the impact of this therapy on quality of life and psycho-emotional aspects like anxiety and depression. The treatment involves applying monopolar non-ablative radiofrequency and electromagnetic low-intensity shock wave therapy directly to the fibrotic plaque on the penis. Treatments are given 2 to 5 times a week, depending on the patient's availability, for a total of 24 sessions. Specific devices are used to deliver radiofrequency at a controlled temperature and shock waves with set energy and frequency parameters to the affected area. Participants will complete five validated questionnaires and undergo physical assessments including palpation and ultrasound of the fibrotic plaque. Evaluations occur before treatment, after treatment, and one month post-treatment. Satisfaction and symptom changes are measured regularly during treatment. Telephone follow-ups at 3, 6, 9, and 12 months after treatment assess long-term effects. Researchers will monitor sexual function, pain, erection quality, and psychosocial factors throughout the study.

Researchers are evaluating the safety, pharmacokinetics, preliminary antitumor activity, and pharmacodynamics of pocenbrodib, alone or combined with abiraterone acetate, olaparib, or 177Lu-PSMA-617, in men with metastatic castration-resistant prostate cancer (mCRPC) who have progressed after prior therapies including at least one potent anti-androgen treatment. This Phase 1b/2a open-label study aims to find an appropriate dose and assess early treatment effects in this population. The Phase 1b part tests five increasing doses of pocenbrodib monotherapy (50, 100, 150, 200, and 250 mg) given once daily for 5 days followed by 2 days off. Participants start at the lowest dose with careful safety monitoring before moving to higher doses. If safety and minimum efficacy are demonstrated, Phase 2a begins, enrolling four groups: pocenbrodib alone, or combined with abiraterone acetate, olaparib, or 177Lu-PSMA-617. These groups run simultaneously but are evaluated separately. Participants will have regular assessments including imaging and prostate-specific antigen (PSA) tests to measure treatment response and progression. Safety and dose-limiting toxicities are closely tracked over 28-day cycles. Pharmacokinetic measures like plasma drug concentrations and half-life will be recorded. The study period extends up to about 32 months, with outcomes such as tumor response, progression-free survival, and overall survival monitored to understand the treatment's effects.

Researchers are evaluating the effects of Platelet-Rich Plasma (PRP) injections in men diagnosed with Peyronie's disease (PD) during its fibrotic phase. The study aims to assess how PRP may influence penile curvature and other related symptoms compared to a placebo treatment. A total of 84 male participants with specific degrees of penile curvature will be involved in this randomized, double-blind clinical trial. Participants are divided into two groups based on their penile curvature severity and randomized to receive either PRP or saline solution injections. Each participant will undergo weekly intralesional injections of 6 mL either PRP or saline for three weeks. Alongside the injections, all participants will perform daily penile stretching exercises from the first injection until the three-month follow-up. The trial includes a baseline visit, a three-month post-treatment follow-up, and additional long-term assessments at six and twelve months. Throughout the study, participants will have their penile curvature measured and evaluated at multiple points, including 12 months after treatment. Other outcomes assessed include plaque size, erectile hardness, depressive symptoms, ability to engage in sexual intercourse, preference for surgery, and global assessment scales. Data collection involves questionnaires, medical records, and physical examinations. This follow-up schedule allows researchers to monitor changes over time and analyze the effectiveness and safety of PRP treatment in this condition.

Researchers are evaluating the usefulness of Platelet-Rich Plasma Injections from Cord Blood (CB-PRP) in treating Peyronie's disease, a condition involving penile curvature. This study compares patient satisfaction and other health measures between two groups: those using penile traction alone and those using penile traction combined with CB-PRP injections. The main goal is to assess satisfaction using the Peyronie's Disease Questionnaire (PDQ) at 1 and 3 months after treatment. Participants will be randomly assigned to one of two groups. One group will use a penile extender device alone, while the other will receive three CB-PRP injections every 15 days in addition to using the penile extender. This open-label study takes place at a single center and is sponsored by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico. During the study, researchers will measure penile curvature with a goniometer during spontaneous erection and penile length in a stretched state before and after treatment at 1 and 3 months. Quality of life will also be evaluated using the Short-Form Health Survey 12 (SF-12) and the Hospital Anxiety and Depression Scale (HADS). Patient satisfaction will be followed for up to 6 months after enrollment, with safety and health assessments including blood counts and infection screening.

This research aims to assess the safety and effectiveness of using autologous engineered urethral constructs for treating urethral strictures in adult males. It is a Phase I, prospective, non-randomized, and uncontrolled single-center study enrolling male patients aged 21 to 65 years with recurrent urethral strictures who have previously undergone treatments such as dilation, urethrotomy, or urethroplasty. Participants will have full-thickness bladder biopsies to collect urothelial and smooth muscle cells, which will be expanded in the lab and seeded onto tubular polyglycolic acid scaffolds to create personalized urethral constructs. Around six weeks after biopsy, participants will undergo surgery to remove the urethral stricture and implant the engineered construct. All subjects will be followed for safety and efficacy over a 36-month period. During the study, participants will have follow-up visits to monitor for any adverse events related to the product, biopsy, or injection procedures. Effectiveness of the urethral construct in repairing the stricture will be assessed throughout the 36 months. The study involves surgical procedures, cell culture, and long-term monitoring to evaluate the treatment approach comprehensively.