ProstateAI - A Prospective Paired Validating Cohort Study to Evaluate an MRI-based Optimized Prostate Cancer Diagnostic Pathway Powered by Artificial Intelligence
It is a prospective paired-cohort study for diagnostic test evaluation. The study aim to determine the accuracy of AI review and investigate whether AI review could detect MRI visible significant cancer as effective as radiologist review. MRI image of about 102 men recommended for biopsy will be reviewed by an AI model and an experienced radiologist, respectively. AI review (index) and radiologist review (standard) will be blinded to each other, while biopsy urologists will be well-informed of the findings of both AI review and radiologist review and make personalized biopsy plan by combining both findings. The pathological results of MRI-ultrasound fusion biopsy (reference) will serve as the gold standard to assess the diagnostic accuracy.
NCT06360523 — Prostate Cancer
Status: Not yet recruiting
http://inclinicaltrials.com/prostate-cancer/NCT06360523/
A Study to Evaluate Safety, Whole-Body Distribution and Radiation Dosimetry of ZA-001, an Alpha-particle-emitting (At211) Radiopharmaceutical, in Metastatic Castration Resistant Prostate Cancer
A Study to Evaluate Safety, Whole-Body Distribution and Radiation Dosimetry of ZA-001, an Alpha-particle-emitting (At211) Radiopharmaceutical, in metastatic castration resistant prostate cancer
NCT06359821 — Metastatic Prostate Cancer
Status: Enrolling by invitation
http://inclinicaltrials.com/metastatic-prostate-cancer/NCT06359821/
Ultrahypofractionated, Adaptive Radiation Therapy of Prostate Cancer - Ultra-HART
In this prospective, multi-center cohort study, the tolerability and quality of life during ultrahypofractionated radiotherapy (RT) of early stage prostate cancer is surveyed at several institutions in Germany. Radiotherapy is delivered with by an online-adaptive RT device (Varian Ethos), which is able to correct daily variations in anatomy and to adjust the irradiation plan accordingly. A digital patient questionnaire is used to asses quality of life longitudinally. Quality of life (QoL) and toxicity profiles will be correlated with planning parameters and compared to retrospective cohorts of patients who underwent normofractionated RT or moderately hypofractionated RT, respectively.
NCT06355050 — Prostate Cancer
Status: Not yet recruiting
http://inclinicaltrials.com/prostate-cancer/NCT06355050/
Phase II Study Evaluating the Effects of Single Site Intratumoral Injections of Anti-CD40 Agonist Antibody (2141-V11) Given as Monotherapy Prior to Radical Prostatectomy to Men With Intermediate Risk Disease and in Combination With Androgen Deprivation Therapy for Those With High Risk Localized and Low Volume Metastatic Disease
The purpose of this study is to see whether combining 2141-V11 with various standard treatments is an effective treatment approach for prostate cancer. 2141-V11 works by activating the immune system to find and kill cancer cells. Researchers will look at whether this treatment approach is able to completely get rid of cancer in participants, and they will check for the presence of minimal residual disease (MRD) in participants. MRD is a small number of cancer cells that can be detected in the body after treatment.
NCT06347705 — Prostate Cancer
Status: Recruiting
http://inclinicaltrials.com/prostate-cancer/NCT06347705/
Phase II Trial of In-Situ Autologous Vaccination With Intratumoral and Systemic Hiltonol® (Poly-ICLC) Administered to Prostate Cancer Patients on Active Surveillance
This is a partially blinded randomized controlled phase II pilot study comparing Poly-ICLC (Hiltonol®) treatment vs no treatment, for prostate cancer participants on active surveillance.
NCT06343077 — Prostate Cancer Patients on Active Surveillance
Status: Recruiting
http://inclinicaltrials.com/prostate-cancer-patients-on-active-surveillance/NCT06343077/
Dual PSMA and FDG PET Imaging for Patients With Advanced Prostate Cancer
This study will use Prostate Specific Membrane Antigen (PSMA) and (18)F-Fluorodeoxyglucose Positron Emission Tomography (FDG PET) imaging in patients with advanced prostate cancer to learn about tumor biology across disease stages and during treatment. This may help with treatment selection and potential response monitoring in the future.
NCT06335914 — Advanced Prostate Cancer
Status: Not yet recruiting
http://inclinicaltrials.com/advanced-prostate-cancer/NCT06335914/
Safety and Efficacy Study of Adjuvant Hypofractionated Radiotherapy Following Radical Prostatectomy for Prostate Cancer
Hypofractionated radiation therapy is a new type of radiotherapy which has been shown to play a larger role in the treatment of prostate cancer. The aims of the trial were to evaluate the safety and feasibility of adjuvant hypofractionated radiotherapy following radical prostatectomy for prostate cancer.
NCT06335693 — Prostate Cancer
Status: Recruiting
http://inclinicaltrials.com/prostate-cancer/NCT06335693/
CyberKnife Ultra-hypofractionated SBRT for Localized PROStatE cancEr With Dose-escalation to the Dominant Intraprostatic Lesion: is the Juice Worth the Squeeze? The PRO-SPEED Trial
This is a prospective observational study. The study will proceed with the enrollment of 60 patients in 2 years. he aim of the present study is to evaluate effectiveness of ultra-hypofractionated (UH) CyberKnife Stereotactic Body Radiation Therapy treatment on the whole prostate gland plus Simultaneous integrated boost (SIB) to the dominant intraprostatic lesions (DIL(s) in intermediate-unfavourable to high-risk Prostate Cancer (PCa) patients.
NCT06331013 — Prostate Cancer
Status: Recruiting
http://inclinicaltrials.com/prostate-cancer/NCT06331013/
A Comparison of Orgovyx (Relugolix) vs Eligard (Leuprolide) on Cardiovascular Function and Biomarkers During Standard of Care Combined ADT (Androgen Deprivation Therapy)-Radiation for Prostate Cancer
This phase II trial compares the effect of relugolix to leuprolide on cardiac function and performance in patients with prostate cancer. Androgen deprivation therapy (ADT) has been a key component for the treatment of advanced prostate cancer for decades. The term androgen deprivation therapy means lowering a man's testosterone. Long-term studies show that ADT may contribute to a detriment to cardiac health and predisposes men to developing cardiac diseases. Recent studies suggest that men taking relugolix for treatment of prostate cancer may have a lower risk of developing cardiovascular problems, but more studies are needed to understand this observation, and there are currently no studies reporting the direct impact of ADT (relugolix, versus the more-commonly used leuprolide) on cardiac function and outcomes. Participants will receive definitive radiotherapy for unfavorable intermediate risk prostate cancer and 6-month ADT (either relugolix or leuprolide). In addition, participants will undergo the following: 1. Comprehensive cardiac and exercise testing before and after starting ADT 2. Completion of quality-of-life questionnaires at specific intervals during the study period 3. Provide blood samples at specific intervals during the study period to test for changes in steroid levels and certain biomarkers
NCT06330805 — Prostate Adenocarcinoma
Status: Not yet recruiting
http://inclinicaltrials.com/prostate-adenocarcinoma/NCT06330805/
Safety and Anti-tumor Activity of Lutetium-177 (177Lu)-PSMA-617 Along With Niraparib and Abiraterone Acetate Plus Prednisone in Metastatic Castration Resistant Prostate Cancer - LUNAAR Study
The purpose of this research study is to test the safety and possible side effects of Lutetium-177 (177Lu)-Prostate-Specific Membrane Antigen (PSMA)-617 along with niraparib and abiraterone acetate plus prednisone when it is given to people diagnosed with metastatic castration-resistant prostate cancer (prostate cancer that has spread to other parts of the body and does not improve with hormonal therapies) at different dose levels. Once an optimal dose is selected, the researchers want to find out what how well these treatments work to improve survival and control the growth of the tumor.
NCT06329830 — Metastatic Castration-resistant Prostate Cancer
Status: Not yet recruiting
http://inclinicaltrials.com/metastatic-castration-resistant-prostate-cancer/NCT06329830/