Clinical trials: High-risk Localized Prostate Cancer
Prostate Cancer
Ablatherm Integrated Imaging High Intensity Focused Ultrasound for the Indication of Low Risk, Localized Prostate Cancer
The purpose of this study is to determine the substantial equivalence of the Ablatherm high intensity focused ultrasound (HIFU) as compared to cryotherapy for the treatment of low risk, localized prostate cancer.
- Trial name
- NCT00295802
- Testing
- Integrated Imaging High Intensity Focused Ultrasound, Endocare CRYOcare Cryosurgical and Galil Medical CRYO-HIT Systems (cryotherapy)
- Where
- 15 sites in United States, Canada
- Volunteers
- 141 people
- Sponsor
- EDAP TMS S.A.
Prostate Cancer
Evaluation of Neoadjuvant Xaluritamig in Localized Prostate Cancer
The primary objectives of this study are to evaluate the safety and tolerability of xaluritamig administered as monotherapy or in combination with an oral Gonadotropin-releasing Hormone (GnRH) antagonist in the neoadjuvant…
- Trial name
- NCT06613100
- Testing
- Xaluritamig, GnRH Antagonist
- Where
- 9 sites in United States, Germany
- Volunteers
- 40 people
- Sponsor
- Amgen
Prostate Cancer
Clinical Data Collection of Patients Treated With High Intensity Focused Ultrasound (HIFU) by the Focal One for Their Prostate Cancer.
The aim of the registry is to gather real-life data to evaluate the clinical performance and safety of medical devices in patients who have been treated with HIFU thank to the Focal One device for their prostate cancer.
- Trial name
- One registry (NCT07645872)
- Where
- 5 sites in France
- Volunteers
- 3,000 people
- Sponsor
- EDAP TMS S.A.
Prostate Cancer
Ultrasound in Treating Patients With Recurrent Stage I or Stage II Prostate Cancer
RATIONALE: Ultrasound therapy kills tumor cells by heating them to several degrees above body temperature. This treatment may be effective for prostate cancer.
- Trial name
- NCT00005075
- Testing
- high-intensity focused ultrasound ablation
- Where
- 2 sites in United States
- Sponsor
- EDAP Technomed
Prostate Cancer
Study to Assess [177Lu]Lu-PSMA-R2 (AAA602) and [225Ac]Ac-PSMA-R2 (AAA802) in Participants With PSMA-positive HRLPC
The purpose of this trial is to learn more about the effects of AAA602 and AAA802 in men with prostate-specific membrane antigen (PSMA) positive high-risk localized prostate cancer (HRLPC) before surgery to remove the prostate…
- Trial name
- NeoPSMA (NCT06881823)
- Testing
- AAA602, AAA802, Gallium (68Ga) gozetotide
- Sponsor
- Novartis Pharmaceuticals
Prostate Cancer
A Phase 2 Study to Evaluate Safety and Efficacy of Abiraterone Acetate in Male Participants With Prostate Cancer
The purpose of this study is to evaluate safety and efficacy of abiraterone acetate plus leuprolide acetate and prednisone, versus leuprolide acetate alone in male participants with prostate cancer (a disease in which cells in…
- Trial name
- NCT00924469
- Testing
- Abiraterone, Leuprolide, Prednisone
- Where
- 4 sites in United States
- Volunteers
- 58 people
- Sponsor
- Janssen Research & Development, LLC
Prostate Cancer
Treatment of Localized Prostate Cancer With High Intensity Focused Ultrasound Using the Sonablate® 500 System in Canada
This is an investigational study on the use of high intensity focused ultrasound (HIFU) in the management of localized prostate cancer (T1c/T2a) as a primary non-comparative study.
- Trial name
- NCT00573586
- Testing
- Sonablate 500 (SB-500)
- Where
- Canada
- Volunteers
- 20 people
- Sponsor
- SonaCare Medical
Prostate Cancer (Adenocarcinoma), Adenocarcinoma of the Prostate
RYZ711 Diagnostic Platform Study
This is a Phase 1/2 multicenter, multi-cohort imaging study to evaluate the safety, tolerability, and diagnostic performance of RYZ711 positron emission tomography/computed tomography (PET/CT) in men with histologically confirmed…
- Conditions
- Prostate Cancer (Adenocarcinoma), Adenocarcinoma of the Prostate, Metastatic Castration-resistant Prostate Cancer (mCRPC), Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
- Trial name
- NCT07862582
- Testing
- RYZ711, PSMA PET/CT
- Where
- United States
- Volunteers
- 116 people
- Sponsor
- RayzeBio, Inc.
Prostate Cancer
A Study of Metastases Free Survival With Saruparib vs Placebo Added to a Standard RT/ADT in Men With High-risk Prostate Cancer With a BRCA Mutation
The purpose of the study is to demonstrate superiority of Saruparib (AZD5305) relative to placebo added to a standard radiation therapy (RT) + androgen deprivation therapy (ADT) regimen by assessment of metastases-free survival…
- Trial name
- EvoPAR-PR02 (NCT06952803)
- Testing
- Saruparib, Abiraterone + Prednisolone/Prednisone, Androgen Deprivation Therapy (ADT)
- Where
- 346 sites in United States, Argentina and 26 more
- Volunteers
- 700 people
- Sponsor
- AstraZeneca
Prostate Cancer
Targeted Prostate Biopsy Using a Novel MRI-Ultrasound Fusion Device
The purpose of this study is to evaluate the effectiveness of Focal-Fusion Bx at detecting clinically significant prostate cancer in a standard clinical environment.
- Trial name
- NCT02524860
- Testing
- Focal-Fusion Bx
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Focal Healthcare Inc.
Prostatic Neoplasms
An Efficacy and Safety Study of JNJ-56021927 (Apalutamide) in High-risk Prostate Cancer Subjects Receiving Primary Radiation Therapy: ATLAS
The purpose of this study is to determine if apalutamide plus gonadotropin releasing hormone (GnRH) agonist in participants with high-risk, localized or locally advanced prostate cancer receiving primary radiation therapy (RT)…
- Trial name
- NCT02531516
- Testing
- Apalutamide, Bicalutamide, GnRH (agonist)
- Where
- 263 sites in United States, Argentina and 21 more
- Volunteers
- 1,503 people
- Sponsor
- Aragon Pharmaceuticals, Inc.
Patients With High-risk Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy
A Trial of SHR3680 in Prostate Cancer Patients Who Are Candidates for Radical Prostatectomy
The study is being conducted to evaluate the efficacy and safety of SHR3680 plus androgen deprivation therapy (ADT) vs. placebo plus ADT in patients with high-risk localized or locally advanced prostate cancer using pathologic…
- Trial name
- NCT05009290
- Testing
- SHR3680
- Where
- China
- Volunteers
- 391 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Prostate Cancer
Neoadjuvant Study of In-situ REIC/Dkk-3 in Prostate Cancer
This is a phase I neoadjuvant gene therapy followed by prostatectomy, open-label, dose-escalation trial for prostate cancer patients with high risk of local recurrence after radical prostatectomy.
- Trial name
- NCT01197209
- Testing
- Ad-REIC/Dkk-3
- Where
- United States
- Sponsor
- Momotaro-Gene Inc.
High Risk Localized Prostate Cancer
A Study of High Risk Localized Prostate Cancer Participants Treated With Radical Prostatectomy and Perioperative Hormonal Therapy
The purpose of this study is to evaluate the yearly conditional prostate-specific antigen (PSA) progression-free survival (PFS) probabilities in high-risk localized prostate cancer (HR LPC) participants following radical…
- Trial name
- ACE (NCT05303558)
- Where
- 9 sites in Japan, South Korea and 1 more
- Volunteers
- 221 people
- Sponsor
- Johnson & Johnson International (Singapore) Pte. Ltd.
Benign Prostatic Hyperplasia
Evaluation of the Safety of the Treatment of Benign Prostatic Hyperplasia by High Intensity Focused Ultrasound.
Prostate adenoma or benign prostatic hypertrophy (BPH) is a benign disease of the prostate gland. It results in an increase in the volume of the prostate area located in contact with the urethra.
- Trial name
- NCT04853914
- Testing
- HIFU treatment
- Where
- France
- Volunteers
- 9 people
- Sponsor
- EDAP TMS S.A.
Cancer of Prostate
Dynamic Focusing Evaluation for Prostate Cancer Treatment
Define the best acoustic parameters for the dynamic focusing HIFU transducer in the treatment of localized Prostate Cancer.
- Trial name
- FOC/DYN (NCT03632980)
- Testing
- "Ablatherm Foc/Dyn" or "Focal One" HIFU treatment
- Where
- France
- Volunteers
- 180 people
- Sponsor
- EDAP TMS S.A.
Prostatic Neoplasms
A Study of Apalutamide in Participants With High-Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy
The purpose of this study is to determine if treatment with apalutamide plus androgen deprivation therapy (ADT) before and after radical prostatectomy (RP) with pelvic lymph node dissection (pLND) in participants with high-risk…
- Trial name
- PROTEUS (NCT03767244)
- Testing
- Apalutamide, Androgen Deprivation Therapy (ADT)
- Where
- 203 sites in United States, Argentina and 16 more
- Volunteers
- 2,517 people
- Sponsor
- Janssen Research & Development, LLC
Localized Prostate Cancer, BPH (Benign Prostatic Hyperplasia)
Sonablate HIFU International Registry for PC & BPH Patients
The SONA FUSION Registry is an observational study designed to evaluate the long-term effectiveness and safety of the Sonablate High-Intensity Focused Ultrasound (HIFU) system.
- Conditions
- Localized Prostate Cancer, BPH (Benign Prostatic Hyperplasia), Prostate Cancer; Benign Prostatic Hyperplasia
- Trial name
- SONAFUSION (NCT07757490)
- Testing
- High Intensity Focused Ultrasound
- Where
- United States
- Volunteers
- 10,000 people
- Sponsor
- Sonablate
Prostate Cancer
Investigational Study For the Treatment of Localized (T1c/T2a) Prostate Cancer With High Intensity Focused Ultrasound (HIFU) Using the Sonablate 500 (SB-500) System in Canada
An investigational study on the use of HIFU in the management of localized prostate cancer as a primary non-comparative study High intensity focused ultrasound (HIFU) is a non-invasive acoustic ablation technique that uses…
- Trial name
- NCT00537849
- Testing
- Sonablate 500(SB-500)
- Where
- Canada
- Sponsor
- SonaCare Medical
Prostate Cancer
High-Intensity Focused Ultrasound in Treating Patients With Locally Recurrent Prostate Cancer
RATIONALE: Highly focused ultrasound energy may be able to kill cancer cells by heating the tumor without affecting the surrounding tissue.
- Trial name
- NCT00030277
- Testing
- high-intensity focused ultrasound ablation
- Where
- 2 sites in United States
- Volunteers
- 20 people
- Sponsor
- Focus Surgery