Advanced Prostate Cancer Clinical Trial
Official title:
PRORAD-5 PROstate RADiation in 5 Fractions: Phase Ib Five Fraction Radiotherapy for Patients With Advanced Prostate Cancer
To look at the safety and effectiveness of stereotactic body radiation therapy (SBRT) in treating advanced or high-risk prostate cancer.
Primary Objectives: Primary Objective #1: To determine the proportion of patients experiencing late grade ≥ 3 GI toxicity after five fraction pelvic nodal RT as reported by the treating physician at 3 months post-treatment. Primary Objective #2: To estimate the change in health-related quality of life (HRQOL) following the proposed treatment regimen compared to pre-treatment assessment 6 months after completing RT. Patient-reported urinary, bowel, and sexual function and general QoL will be collected using validated EPIC-26, EQ-5D, PROMIS-Fatigue questionnaires prior to RT, at the end of RT 3, and 6, 12, 24 months after completion of RT. Secondary Objectives: Secondary Objective #1: To estimate the metastasis free survival (MFS) at 24 months after study enrollment. All time-to-event analyses will be analyzed indexed to date of study enrollment. Secondary Objective #2: To estimate the rate of acute and late GI and GU toxicity of the treatment regimen Secondary Objective #3: To assess adherence to protocol treatment parameters. RT plans will be evaluated for contouring consistency, target coverage and tissue constraint adherence with the use of artificial intelligence (AI) auto-segmentation/contours and scorecards to facilitate this process and improve plan quality and clinical efficiency. Secondary Objective #4: To explore the impact of five fraction pelvic nodal RT on lymphopenia. White blood cell counts will be obtained before and after treatment and compared to historical data on lymphopenia with conventionally fractionated pelvic RT. Secondary Objective #5: To estimate HRQOL following the proposed treatment regimen compared to pre-treatment assessment at the end of RT 3 months, 12, and 24 months after completing RT and assess the HRQOL change over time. Exploratory Objective #1: To investigate the effect of pelvic nodal RT on gut microbiome with gut microbiome sample collection pre- and upon RT completion. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT06006104 -
Phase 1/2 Clinical Study of HRS-4357 in Patients With Advanced Prostate Cancer
|
Phase 1/Phase 2 | |
Recruiting |
NCT03936218 -
Goserelin 10.8mg Injection in Treatment of Advanced Prostate Cancer
|
Phase 3 | |
Completed |
NCT02234089 -
Therapy Pathways in the Treatment of Hormone Naïve Prostate Cancer Patients With and Without Comorbidities Treated With Degarelix or Luteinizing-Hormone-Releasing-Hormone (LHRH) Agonists.
|
||
Completed |
NCT01078545 -
Lucrin® Depot Efficacy and Safety Monitoring Study in Patients With Advanced Prostate Cancer and Lower Urinary Tract Symptoms (LUTS)
|
N/A | |
Active, not recruiting |
NCT03511196 -
Intermittent Androgen Deprivation Therapy for Stage IV Castration Sensitive Prostate Cancer
|
Early Phase 1 | |
Recruiting |
NCT05942001 -
Study of HRS-5041 in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)
|
Phase 1 | |
Active, not recruiting |
NCT04117594 -
Whole Body Magnetic Resonance Imaging Study
|
||
Completed |
NCT01383863 -
A Long-term Observational Study Cohort in Patients With Advanced Prostate Cancer
|
||
Completed |
NCT03651271 -
Nivolumab With or Without Ipilimumab in Advanced Metastatic Cancer
|
Phase 2 | |
Active, not recruiting |
NCT05590793 -
Effects of Triptorelin Pamoate 6-month When Given to Adult Chinese Participants With Advanced Cancer in the Prostate
|
Phase 3 | |
Recruiting |
NCT06095089 -
A Study of JNJ-87189401 Plus JNJ-78278343 for Advanced Prostate Cancer
|
Phase 1 | |
Active, not recruiting |
NCT02362620 -
PROSTAC: Prospective Multi-centre Study of Prognostic Factors in mCRPC Patients Treated With Docetaxel or Cabazitaxel.
|
||
Active, not recruiting |
NCT02787837 -
PROSABI: Prospective Multi-centre Study of Prognostic Factors in mCRPC Patients Treated With Abiraterone Acetate.
|
||
Recruiting |
NCT05800665 -
A Study Evaluating the Safety, Pharmacokinetics, and Activity of RO7656594 In Participants With Advanced or Metastatic Prostate Cancer
|
Phase 1 | |
Recruiting |
NCT03938649 -
SRAM study_Postate Cancer
|
Phase 2 | |
Completed |
NCT00871585 -
Evaluation of Prostate-Specific Antigen (PSA) Levels in Patients With Advanced Prostate Cancer Treated With Bicalutamide
|
N/A | |
Active, not recruiting |
NCT02922218 -
PROSENZA: Prospective Multi-Centre Study of Prognostic Factors in mCRPC Patients Treated With Enzalutamide.
|
||
Not yet recruiting |
NCT06335914 -
Dual PSMA and FDG PET Imaging for Patients With Advanced Prostate Cancer
|
N/A | |
Terminated |
NCT03577028 -
Study of HPN424 in Patients With Advanced Prostate Cancer
|
Phase 1/Phase 2 | |
Terminated |
NCT03971110 -
A Study of Neoadjuvant Hormone Therapy in Patient With Advanced Prostate Cancer Undergoing Radical Prostatectomy.
|
Phase 4 |