Peyronie's disease is a condition where fibrous scar tissue develops in the penis, causing curvature. Explore research studies for Peyronie's disease near you.

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Found 16 Actively Recruiting clinical trials

F

Actively Recruiting

The imaging analysis will consist in obtaining quantitative measurements of lesion uptake on the pre- and post-LuPSMA RLT (lesion and whole-body SUVmax, SUVmean and tumor volume) at each time point on all PET/CT scans. PET metrics at the lesion- and whole-body level will be compared among different PET radiopharmaceuticals at the same time point, and changes over time will be assessed. All patients will be followed-up at our institution and clinical outcome will be correlated to the imaging analysis assessment.

Age: 18Years +MALEPhase 4
1 location
C

Actively Recruiting

This is a phase II study in which fifty adult patients with cTxN1-3 locoregionally advanced squamous cell penile cancer (LRAPC), suitable for resection will be included. Patients with recurrence in lymph nodes are suitable for inclusion if they have not received prior systemic treatment. Patients with cN1 are only included in case of central nodal necrosis and/or an irregular nodal border, or node \>3cm on CT. A maximum of 2 supraregional or distant metastases is allowed if local treatment (i.e. irradiation or resection) is feasible. Patients will be treated with three 21-day cycles of induction chemotherapy, carboplatin AUC5 (max 750 mg) and paclitaxel 175 mg/m2, with additional fixed-dose 400mg pembrolizumab on the first and third cycle. Response to induction therapy will be evaluated by CT scan, ca. 2 weeks after the last cycle. Subsequent consolidative treatment will consist of surgical resection of all visible and/or suspected disease. In 3-9 weeks after surgery, patients will enter the adjuvant phase, consisting of 7 cycles of pembrolizumab 400 mg every 6 weeks. Focused physical examination, registration of adverse-events and monitoring of, amongst others, TSH, FT4, liver enzymes via blood tests, is performed at the start of every cycle. End of treatment visit will be set 30 days after receiving the last cycle of pembrolizumab. Disease status will be monitored by CT-scan at 3, 6, 9, 12, 18 and 24 months from resection, after which imaging will follow standard follow-up protocols. QoL will be assessed at 3,6,12, 18 and 24 months using using the EORTC QLQ-C30 questionnaire. Following 24 months after resection subsequent follow-up visits for survival and anti-cancer therapy will be planned every 6 months, until death, withdrawal of consent or the end of the study, whichever occurs first. The primary endpoint is efficacy, defined as pathological complete response (pCR). Secondary endpoints are grade 3-4 toxicity (by CTCAE 5.0), PFS and OS at 2 years after surgery, correlation of clinical endpoints (pCR, PFS, OS) with high-risk HPV (hrHPV) and PD-L1 immunohistochemistry, and quality of life.

Age: 18Years +MALEPhase 2
2 locations
C

Actively Recruiting

The purpose of this research is to determine whether or not low-intensity shockwave therapy (LiSWT) with Xiaflex treatment will result in greater improvements to the curvature of the penis.

Age: 18Years +MALEPhase Not Applicable
1 location
D

Actively Recruiting

The current study would prospectively follow 40 men through the following treatment protocol: * Men would receive 4 series of CCH injections according to the protocol below, which represents a modified version of our most recently published technique.13 * Medication administered on back-to-back days * Total of 0.9 mg administered with each series, diluted to 0.8 mL * Mild in-office modeling performed on treatment day 2 of each series * Wraps performed ranging from 2-4 full-time and 2-4 part-time days to minimize bruising * Sildenafil 25 mg nightly beginning treatment day 2 until 6 weeks after final injection of the final series. * Restorex initiated beginning on post-injection day 3 or as soon as tolerated - 30 min daily, continuing until 6 weeks after final injection of the final series. * Note that men may stop sooner if they are satisfied before completing the 4 series. * If the patient is not satisfied with outcomes by the end of the 4th series, they would be permitted to enter the 'salvage' phase of the treatment protocol. * This would be performed 9-12 months after the 4th series of injections. * The technique would be similar to the one noted above with the exception of more aggressive in-office modeling as described in our prior publication and per our ongoing randomized trial. * The men would receive up to two additional series per this protocol for a maximum number of cycles being 6 in total. At the time of initial enrollment, partners of study participants will be invited to enroll in the study and will be administered non-validated questionnaires designed to assess the partner's overall support for the ongoing treatment protocol. Assessments and study questionnaires will be administered at baseline, with the 1st injection of each series, 6 weeks after completing the 4th series of CCH injections, and 1 year after completion of the final series of CCH injections.

Age: 18Years +All GendersPhase 4
1 location
E

Actively Recruiting

Healthy Volunteer

The study is designed as a single-center, prospective clinical trial. Participants will be selected from among patients who present to the clinic and are diagnosed with stable stage Peyronie's disease. All participants who meet the eligibility criteria and provide written consent will undergo a standard Extracorporeal Shockwave Therapy protocol. All participants will be evaluated before and after treatment using the International Erectile Function Index-5 and the Quality of Life Questionnaire short form. The results will be statistically analyzed and interpreted.

Age: 18Years - 65YearsMALEPhase Not Applicable
1 location
N

Actively Recruiting

The goal of this one arm clinical trial is to evaluate the safety and describe the clinical response of non-ablative radiofrequency treatment associated with shockwave therapy in men with Peyronie's disease. The main question\[s\] it aims to answer are: • is the treatment safe? • is there any clinical response to the proposed treatment? Participants will respond to five validated questionnaires: International Index of Erectile Dysfunction (IIEF-5), Medical Outcomes Study 36 - Item Short - Form Health Survey (SF-36), Peyronie's Disease Questionnaire (PDQ), Scale Hospital for Anxiety and Depression (SHAD) and the Erection Quality Questionnaire (EQQ); will undergo a physical assessment that includes palpation of the fibrotic plaque on the penis, pharmacological induction of erection, and assessment of the size of the fibrotic plaque through ultrasound. Every five sessions, the participant's degree of satisfaction will be measured using a 5-point Likert scale, as well as the evolution of symptoms will also be observed, using a 10-point Visual Analogue Scale (VAS) and penile pain, if present. The entire evaluation protocol will be applied before (pre-test), after treatment (post-test) and 1 month after the end of treatment. Volunteers will be monitored by telephone to verify the long-term response after 3, 6, 9 and 12 months of completed treatment in relation to the Likert scale and VAS. The treatments they'll be given are • of monopolar non-ablative radiofrequency associated with • low-intensity shock wave therapy.

Age: 18Years - 80YearsMALEPhase Not Applicable
1 location
O

Actively Recruiting

This is a Phase 1b/2a multicenter, open-label study to confirm the safety, pharmacokinetics (PK), preliminary antitumor activity, and pharmacodynamics (PD) of pocenbrodib for the treatment of participants with mCRPC who have progressed despite prior therapy and have been treated with at least 1 potent anti-androgen therapy (enzalutamide, apalutamide, abiraterone acetate, or darolutamide). The Phase 1b portion of the study involves pocenbrodib monotherapy at multiple, sequential five rising doses (50, 100, 150, 200, and 250mg) initially using a QD dosing schedule of 5 days on/2 days off. The first dose level (50 mg) will enroll at least 3 participants (with 3 more added if the first 3 participants yield 1 dose-limiting toxicity). Once safety is confirmed through Data Review Committee (DRC), the next higher pocenbrodib dose level cohort can begin enrollment. If both acceptable safety and minimal threshold of efficacy (predefined as 30% PSA50 are achieved, the sponsor will proceed to Phase 2a. Phase 2a will enroll participants in each of 4 cohorts: pocenbrodib monotherapy (2A), and 3 combination therapy cohorts: pocenbrodib + abiraterone acetate (2B), pocenbrodib + olaparib (2C), and pocenbrodib + 177Lu-PSMA-617 (2D). All cohorts may enroll in parallel, but each cohort will be evaluated independently for safety and efficacy.

Age: 18Years +MALEPhase 1Phase 2
18 locations
P

Actively Recruiting

The study protocol is structured such that participants, after being informed about the project and providing consent, will attend a baseline visit where relevant data will be collected from the participant, questionnaires, the patient's medical record, and through an objective examination. A total of 84 patients with Peyronie's disease will be included. Participants will be stratified based on the degree of penile curvature at baseline (30-60 degrees or \>60 degrees) and randomized in a 1:1 ratio to receive either active treatment with Platelet-Rich Plasma (PRP) or placebo (saline). Subsequently, participants will attend weekly injection sessions for 3 weeks consisting of either PRP or saline in a randomized, double-blind manner. A follow-up visit will take place three months after the final injection for outcome assessment. Two additional long-term follow-up visits will be conducted at 6 and 12 months post-treatment. Analysis will then be conducted.

Age: 18Years +MALEPhase Not Applicable
1 location
P

Actively Recruiting

The goal of this clinical trial is to learn if Platelet-Rich Plasma Injections from Cord Blood (CB-PRP) is useful in Peyronie disease. The primary goal is evaluation of patient satisfaction at 1 and 3 months after treatment completion using the PDQ Questionnaire Secondary Objectives are: * Measurement of penile curvature measured with a goniometer with spontaneous erection before and after treatment (1 and 3 months) * Measurement of penile length in stretching before and after treatment (1 and 3 months) * Evaluation of the improvement in quality of life, through the Short-Form Health Survey 12 (SF-12) health status questionnaire and through the Hospital Anxiety and Depression Scale (HADS) Participants will be randomized in two groups: * penile extender alone * penile extender + CB PRP injection (1 injection every 15 days - 3 in totalinjections)

Age: 18Years - 75YearsMALEPhase Not Applicable
1 location
S

Actively Recruiting

The purpose of this study is to learn about the safety and side effects of intralesional collagenase clostridium histolyticum (CCH) injected into the Peyronies Disease (PD) plaque after receiving prior treatment with intralesional Platelet Rich Plasma (PRP) injections.

Age: 18Years - 75YearsMALEPhase 4
2 locations

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