The Combination of PSMA-PET/MRI and p2PSA in Early Diagnosis of Prostate Cancer
This is a single center prospective non-randomized controlled study. The goal of this clinical trial is to figure out whether the combination of PSMA-PET/MR and PHI could add values to each method alone. The main questions it aims to answer are: - Compare the diagnostic value of the combination with each alone and set up a diagnostic model. - Compare the diagnostic value of PSMA-PET/MR+PHI to mpMRI+PHI. - Evaluate the diagnostic value the combination of PHI and PSMA-PET/MR in suspected PCA patients. Patients will experience mpMRI or PSMA-PET/MR and their blood samples will be used to test PSA and p2PSA. Prostate biopsy will be the golden standard.
NCT05822726 — Prostate Cancer
Status: Recruiting
http://inclinicaltrials.com/prostate-cancer/NCT05822726/
Prostate Specific Membrane Antigen (PSMA) Scan and Multiparametric MRI for Prostate Biopsy Detection of Clinically Significant Prostate Cancer
Prospective, randomized, phase 2 clinical trial to determine if PSMA PET imaging plus mpMRI improves detection of clinically significant prostate cancer as compared to mpMRI alone.
NCT05820724 — Prostate Cancer Diagnosis
Status: Not yet recruiting
http://inclinicaltrials.com/prostate-cancer-diagnosis/NCT05820724/
Pelvic Nodes Ultra-Hypo Fractionated Versus Conventionally Fractionated IMRT With HDR Brachytherapy Boost in Prostate Cancer: A Collaborative Multi-institutional Non-inferiority Phase 3 Trial. (PCS-XI)
Randomized Phase III study, comparing pelvic ultra-hypo fractionated radiotherapy (UHF: 5Gy/fraction) to a standard or moderate hypo-fractionation (1.8-2.15Gy/fraction), both associated to an HDR prostate +/- adjacent seminal vesicles brachytherapy boost (HDR-BT)+ ADT according to NCCN guidelines. Considering that the calculated bio-equivalent doses to the tumor are similar for all treatment options, the UHF technique is deemed to be non-inferior to the standard approach. Treatment acceptability, tolerance and adverse events will be reported and compared for non-inferiority as the primary objective. Secondary objectives are biochemical control, metastasis-free, disease specific and overall survival.
NCT05820633 — Prostate Cancer
Status: Recruiting
http://inclinicaltrials.com/prostate-cancer/NCT05820633/
Determine the Validity as a Diagnostic Test of the Transrectal Prostate Biopsy With Cognitive Fusion Through Biparametric Magnetic Resonance in the Detection of Non-palpabe Prostate Cancer
The goal of this prospective observational study is to evaluate the diagnostic precision of the Biparametric Magnetic Resonance Imaging (bpMRI) in the detection of clinically significant prostate cancer (PCa) in patients with biochemical suspicion of prostate cancer with PSA (Prostate Specific Antigen) > 4 ng/mL and a normal digital rectal examination and without a biopsy previous to the MRI. Secondary aims are: - Determine the validity as a diagnostic test of the first directed transrectal prostatic biopsy (cognitive fusion) versus systematic biopsy of 12 cylinders in patients with suspicious lesions in the bpMRI. - Develop a predictive nomogram that permits the reduction of the number of prostatic biopsies performed to patients with a low suspicion of prostate cancer in the bpMRI.
NCT05818631 — Prostate Cancer
Status: Recruiting
http://inclinicaltrials.com/prostate-cancer/NCT05818631/
Fully Hybrid 18F-PSMA PET/MRI as One-stop Approach for the Diagnosis of Clinically Significant Prostate Cancer
This project aims to evaluate the role of fully hybrid PET/MRI with 18F-PSMA and multiparametric MR imaging (mpMRI) as one-stop approach for the diagnosis of clinically significant prostate cancer (csPCa). This prospective PET/MRI clinical evaluation will ideally reduce the number of false negative findings, while at the same time, allowing also to reduce the number of unnecessary prostate biopsies in patients with low-risk, clinically indolent PCa. The demonstration that, compared to mpMRI alone, the use of PET/MRI with 18F-PSMA has a superior diagnostic accuracy in detecting men with csPCa will strongly support the inclusion of 18F-PSMA as pre-biopsy triage test, in addition to mpMRI in daily clinical practice.
NCT05815316 — Prostate Cancer
Status: Not yet recruiting
http://inclinicaltrials.com/prostate-cancer/NCT05815316/
Phase II Prospective Monocentric Study on Prostate Cancer Restaging by Using PET/MR With Innovative Radiotracers
The overall goal is to provide an innovative approach to restage patients with biochemical recurrence of prostate cancer by using hybrid PET/MR with innovative radiotracers (68Ga-PSMA and 68Ga-RM2)
NCT05806853 — Prostate Cancer
Status: Completed
http://inclinicaltrials.com/prostate-cancer/NCT05806853/
Pilot Trial to Investigate Immune Response to an Extended Course of Sipuleucel-T Immunotherapy in Patients With Metastatic Castration-resistant Prostate Cancer (OU-SCC-EXCITE)
Proposed immunotherapy with an extended course of Sipuleucel-T treatment may induce a more robust immune response and improve the anti-cancer efficacy of Sipuleucel-T in patients with metastatic Castration-Resistant Prostate Cancer (mCRPC).
NCT05806814 — Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Status: Recruiting
http://inclinicaltrials.com/metastatic-castration-resistant-prostate-cancer-mcrpc/NCT05806814/
Daily Adaptive Stereotactic Body Radiation Therapy for Prostate Cancer With Urethral Sparing: A Prospective Trial Using an Individualized Approach to Reduce Urinary Toxicity
This trial is a prospective, single-arm, multi-center clinical trial designed to assess whether adaptive radiotherapy with urethral sparing for low to intermediate risk localized prostate cancer will translate into a decreased rate of patient reported acute urinary side effects, as measured by the patient reported EPIC-26 questionnaire, compared with the historically reported rate for non-adaptive, non-urethral sparing prostate SBRT.
NCT05804318 — Prostate Cancer
Status: Recruiting
http://inclinicaltrials.com/prostate-cancer/NCT05804318/
A Phase IV, Post-Authorization Safety Study to Investigate the Long-Term Safety of Lutetium (177Lu) Vipivotide Tetraxetan in Adult Participants With Prostate Cancer
The purpose of this post-marketing study is to further characterize the long-term outcome of known or potential risks of lutetium (177Lu) vipivotide tetraxetan also known as [177Lu]Lu-PSMA-617 or 177Lu-PSMA-617 and hereinafter referred to as AAA617. The study also seeks to further characterize (as possible) any other serious adverse reaction(s) in the long-term in adults with prostate cancer who received at least one dose of AAA617 from interventional, Phase I-IV Novartis sponsored clinical trials.
NCT05803941 — Prostate Cancer
Status: Recruiting
http://inclinicaltrials.com/prostate-cancer/NCT05803941/
Phase II Trial of Combination of Focal Prostate Ablation With Androgen Deprivation and Novel Hormonal Therapy for the Treatment of Intermediate Risk Prostate Cancer
The purpose of this study is to determine the proportion of men with residual/recurrent clinically significant prostate cancer (Grade Group ≥2 disease) in the ablated or unablated prostate tissue following the combination treatment of 6-months of androgen deprivation therapy, apalutamide, and partial ablation of the prostate in men with newly diagnosed non-metastatic intermediate risk prostate cancer; specifically, men with a histopathologic diagnosis of Grade Group 2 & 3, with prostate specific antigen level <20 ng/mL. And to assess the safety of the combination treatment of androgen deprivation therapy, apalutamide, and partial ablation of the prostate for the management of these patients.
NCT05790213 — Prostate Cancer
Status: Suspended
http://inclinicaltrials.com/prostate-cancer/NCT05790213/