Clinical trials: Very High Risk Prostate Carcinoma
Locally Advanced and Metastatic Prostate Cancer
Safety and Early Efficacy of Radical Prostatectomy for Newly Diagnosed Very High Risk Locally Advanced and Oligometastatic Prostate Cancer
Prostate cancer is the most common non-skin cancer diagnosed among men and the second leading cause of male cancer deaths in the United States. In 2013, it is estimated that 29,270 men have died from prostate cancer.
- Trial name
- NCT02971358
- Testing
- Radical prostatectomy
- Where
- Austria
- Volunteers
- 200 people
- Sponsor
- Medical University of Vienna
Prostate Adenocarcinoma
Relugolix and Enzalutamide in Combination With Radiation Therapy for the Treatment of Very High Risk Prostate Cancer, OPTIMAL Trial
This phase II trial tests how well relugolix and enzalutamide, in combination with radiation therapy, works in treating patients with very high risk prostate cancer. Relugolix is a form of androgen deprivation therapy.
- Trial name
- NCT06499870
- Testing
- Biopsy, Biospecimen Collection, Computed Tomography
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Sean Sachdev
Prostate Cancer
Darolutamide ± ADT as Neoadjuvant Therapy in High-Risk/Very High-Risk Localized Prostate Cancer
This is a two-Parallel cohort, prospective study, aimed to explore Efficacy and safety of neoadjuvant Darolutamide with or without ADT in high-risk/very high-risk localized-stage prostate cancer.
- Trial name
- ANDARP (NCT07476677)
- Testing
- Darolutamide, Darolutamide combined with ADT
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Prostate Cancer, Prostate Adenocarcinoma
Copper Cu 64 PSMA I&T PET Imaging in Men With Newly Diagnosed Prostate Cancer
This is a prospective, open-label Phase 3 study to evaluate copper Cu 64 PSMA I\&T injection for PET/CT imaging in patients with newly diagnosed unfavorable intermediate high-risk, high-risk or very high-risk prostate cancer.
- Trial name
- Solar-Stage (NCT06235151)
- Testing
- Copper Cu 64 PSMA I&T
- Where
- 43 sites in United States
- Volunteers
- 439 people
- Sponsor
- Curium US LLC
Prostate Cancer Patients, Non-metastatic Prostate Cancer
Radiation Therapy Approaches for People With Prostate Cancer
The purpose of the study is to explore the best ways of giving radiation therapy to balance cancer control and treatment side effects.
- Conditions
- Prostate Cancer Patients, Non-metastatic Prostate Cancer, High Risk Prostate Cancer
- Trial name
- NCT07751159
- Testing
- Standard of Care HDR Brachytherapy, SBRT
- Where
- 7 sites in United States
- Volunteers
- 126 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Prostate Adenocarcinoma
Staging Prostate Cancer With Hybrid C11-Choline PET/MR and mpMRI
The purpose of this study is to find out if a PET/MR scan in combination with standard MRI and CT scans can improve the early detection and treatment of patients with prostate cancer.
- Trial name
- NCT03404648
- Testing
- C-11 choline PET tracer, Gadobutrol, PET/MR scanner
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- Mayo Clinic
Prostate Adenocarcinoma, Stage IIC Prostate Cancer AJCC v8
Androgen Deprivation Therapy (Relugolix) for the Improvement of Diagnostic Imaging (PSMA PET/CT Scan) in Patients With High Risk or Very High Risk Prostate Cancer, The EnrichPSMA Trial
This phase II trial studies how well a short course of androgen deprivation therapy (ADT) with relugolix works in increasing expression of prostate-specific membrane antigen (PSMA) and improving diagnostic imaging with PSMA…
- Conditions
- Prostate Adenocarcinoma, Stage IIC Prostate Cancer AJCC v8, Stage III Prostate Cancer AJCC v8, Stage IV Prostate Cancer AJCC v8
- Trial name
- NCT07025369
- Testing
- Biospecimen Collection, Computed Tomography, Flotufolastat F-18 Gallium
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Mayo Clinic
Very High Risk Prostate Carcinoma
Neoadjuvant Lu-PSMA Radioligand Therapy and Ipilimumab in Men With Very High-risk Prostate Cancer
A randomized, open-label Phase I/II study of neoadjuvant treatment with [177Lu]Lu-PSMA-617 radioligandtherapy (LuPSMA) with or without Ipilimumab in participants with very high-risk prostate cancer who are candidates for Radical…
- Trial name
- NEPI (NCT06388369)
- Testing
- [177Lu]Lu-PSMA-617, Ipilimumab
- Where
- Germany
- Volunteers
- 1 people
- Sponsor
- University Hospital, Essen
Prostate Adenocarcinoma
Perioperative Atezolizumab With MVA-BN-Brachyury and PROSTVAC For Intermediate-Risk And High-Risk Localized Prostate Cancer
This study is a prospective, open label, single arm phase II trial. A total of 22 patients will be treated with atezolizumab, PROSTVAC, and pre-operative MVA-BN-Brachyury to confirm the efficacy of prostatic combination…
- Trial name
- AtezoVax (NCT04020094)
- Testing
- MVA-BN-Brachyury
- Where
- United States
- Sponsor
- University of Utah
Prostate Cancer
Tumor-directed Radiation Therapy for Patients With the Highest Risk Category of Localized Prostate Cancer
HYPO-RT-PC boost is is an open-label, multicentre, phase II trial evaluating safety and efficacy of real-time image-guided tumor-directed ultra-hypofractionated radiation boost and lymph node irradiation for patients with…
- Trial name
- NCT06220435
- Testing
- Ultra-hypofractionated radiotherapy regimen.
- Where
- 2 sites in Sweden
- Volunteers
- 76 people
- Sponsor
- Region Skane
Postoperative or Postradiation Adjuvant Androgen Deprivation Therapy in Locally Advanced Prostate Cancer (High and Very High Risk) Patients
Non-Interventional Study PREVENT
This is a multicentre, non-interventional, prospective study to be carried out in representative medical institutions in order to get the information on administration of postoperative and post-radiation adjuvant androgen…
- Trial name
- PREVENT (NCT02155998)
- Where
- 14 sites in Russia
- Volunteers
- 200 people
- Sponsor
- AstraZeneca
Neoadjuvant Therapy
A Study of Pamiparib Combined With Abiraterone Acetate in Neoadjuvant Treatment of Prostate Cancer
To evaluate the pathological response rate of pamiparib combined with abiraterone acetate in neoadjuvant therapy for surgically resectable high-risk or very high-risk prostate cancer after radical prostatectomy
- Trial name
- NCT05376722
- Testing
- pamiparib, abiraterone, prednisone
- Where
- 3 sites in China
- Volunteers
- 30 people
- Sponsor
- Hongqian Guo
Prostate Cancer
Darolutamide Augments Standard Therapy for Localised Very High-Risk Cancer of the Prostate
The purpose of this study is to determine the effectiveness of darolutamide as part of adjuvant androgen deprivation therapy (ADT) with a luteinising hormone releasing hormone analogue (LHRHA) in men having radiation therapy for…
- Trial name
- DASL-HiCaP (NCT04136353)
- Testing
- Darolutamide, Luteinizing Hormone-Releasing Hormone Analog, External Beam Radiotherapy
- Where
- 93 sites in United States, Australia and 4 more
- Volunteers
- 1,100 people
- Sponsor
- University of Sydney
Prostate Cancer
PSMA-PET Directed Radiation Therapy for High-Risk Prostate Cancer
In this study, prostate cancer patients whose cancer has not spread to the lymph nodes will receive radiation therapy targeted to the prostate and nearby tissues with or without whole pelvis radiation therapy.
- Trial name
- NCT07291557
- Testing
- Prostate Only Radiation Therapy (PORT), Prostate + Whole Pelvis Radiation Therapy (P-WPRT)
- Where
- Canada
- Volunteers
- 250 people
- Sponsor
- AHS Cancer Control Alberta
Prostate Cancer
Trial Comparing Irradiation Plus Long Term Adjuvant Androgen Deprivation With GnRH Antagonist Versus GnRH Agonist Plus Flare Protection in Patients With Very High Risk Localized or Locally Advanced Prostate Cancer
The primary objective of the trial is to assess if GnRH antagonists in combination with external beam radiation therapy improve progression free survival (progression that can be biological, clinical, or death) compared to GnRH…
- Trial name
- PEGASUS (NCT02799706)
- Testing
- Degarelix, approved GnRH agonist, Radiotherapy
- Where
- 39 sites in Belgium, Denmark and 6 more
- Volunteers
- 885 people
- Sponsor
- European Organisation for Research and Treatment of Cancer - EORTC
Prostate Cancer
Multi-arm Multi-modality Therapy for Very High Risk Localized and Low Volume Metastatic Prostatic Adenocarcinoma
The purpose of this study is to test if treatment with medications that reduce the male hormone level in the participant's body for a few months before surgery can shrink prostate cancer as much as possible, which might reduce…
- Trial name
- NCT03436654
- Testing
- Apalutamide, Abiraterone Acetate, Prednisone
- Where
- 11 sites in United States
- Volunteers
- 102 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Intermediate Risk Prostate Cancer, High Risk Prostate Cancer
PROspective Multicenter Observational Study on Elective Pelvic Nodes Irradiation.
The general aim of the study is to describe the use of elective pelvic node irradiation (ENI) in Italy, in patients with intermediate/high/very high-risk prostate cancer patients submitted to adjuvant or radical Radiation Therapy…
- Trial name
- PRO-EPI (NCT03340272)
- Where
- Italy
- Volunteers
- 1,000 people
- Sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Prostate Cancer
177Lu-PSMA as a Systemic Adjuvant Treatment in Patients With High and Very High Risk Prostate Cancer
Single-center, non-commercial phase 2 clinical trial to evaluate 177Lu-PSMA as a systemic adjuvant treatment in patients with high and very high risk prostate cancer after radical treatment using locoregional teleradiotherapy and…
- Trial name
- PSMA-ADJUVO (NCT06449781)
- Testing
- Lutetium (177Lu) vipivotide tetraxetan
- Where
- Poland
- Volunteers
- 200 people
- Sponsor
- Maria Sklodowska-Curie National Research Institute of Oncology
Prostate Cancer, Prostate Cancer (Diagnosis)
Comparison of 177Lu-PSMA-617 and 225Ac-PSMA-617
There is evidence that Actinium-225 Prostate-Specific Membrane Antigen (225Ac-PSMA) has a potentially higher level of efficacy than 177 Lutetium Prostate-Specific Membrane Antigen (177Lu-PSMA) as a radioligand therapy.
- Conditions
- Prostate Cancer, Prostate Cancer (Diagnosis), High-risk Prostate Cancer, Localized Prostate Carcinoma
- Trial name
- LUTACT (NCT07054346)
- Testing
- 177 Lutetium Prostate-Specific Membrane Antigen 617, Actinium-225 Prostate-Specific Membrane Antigen 617, Non-investigational, Prostatectomy
- Where
- United States
- Volunteers
- 45 people
- Sponsor
- Thomas Hope
Prostate Cancer
A Phase II Neoadjuvant Study of Darolutamide Plus ADT in Men With Localized Prostate Cancer
Scientific Rationale: High risk localized prostate cancer (PCa) is associated with higher rates of biochemical recurrence, clinical recurrence, metastasis and PCa-specific death.
- Trial name
- NCT06029036
- Testing
- Darolutamide+ADT
- Where
- China
- Volunteers
- 53 people
- Sponsor
- Peking University First Hospital