Oligometastatic Prostate Carcinoma Clinical Trial
Official title:
Safety and Efficacy Study of Neoadjuvant Radiohormonal Therapy for Oligometastatic Prostate Cancer: a Multi-center Randomized Controlled Clinical Trial
The optimal treatment for oligometastatic prostate cancer (OMPC) is still on its way. Accumulating evidence has proven the safety and feasibility of radical prostatectomy and local or metastasis-directed radiotherapy for oligometastatic patients. The aim of this trial is to compare the safety and feasibility outcomes of metastasis-directed neoadjuvant radiotherapy (naRT) and neoadjuvant androgen deprivation therapy (naADT) followed by robotic-assisted radical prostatectomy (RARP) to ADT combined with abiraterone for treating OMPC.
Status | Not yet recruiting |
Enrollment | 200 |
Est. completion date | March 1, 2028 |
Est. primary completion date | March 1, 2025 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Histologically confirmed adenocarcinoma of the prostate without small cell features - Oligometastatic PCa assessed by Ga-68 prostate-specific membrane antigen (PSMA), PET/CT - <4 bone oligometastases, lymph node metastasis below the renal artery level - Expected survival time >5 years - World Health Organization (WHO) performance status 0-1 - Be willing to give written informed consent. Exclusion Criteria: - Any previous or ongoing treatment for PCa, including radiotherapy, ADT, chemotherapy, focal treatment, etc. - Patients who have previously undergone transurethral resection or enucleation of the prostate. - Patients who have undergone other abdominal surgery within the last 3 months - Patients who have visceral metastases - Patients with a history of long-term anticoagulant use and anti-platelet drug use and who stopped anticoagulant therapy less than 1 week before registration - Patients with other malignancies and acute or chronic infections such as human immunodeficiency virus (HIV) (+), hepatitis C virus (HCV) (+) and/or positive syphilis - Severe or active comorbidities likely to impact the advisability of radiotherapy - Any other serious underlying medical, psychiatric, psychological, familial, or geographical condition, which, according to the judgement of the investigator, may affect the planned staging, treatment and follow-up or patient compliance or may cause high-risk treatmentrelated complications for the patient - Patients who have participated in other clinical trials within the last 3 months - Patients who refuse to undergo RALP - Patients unsuitable for participation in this clinical trial as per the judgement of the investigator. |
Country | Name | City | State |
---|---|---|---|
China | the First Affiliated Hospital of Guangzhou Medical University | Guangzhou | Guangdong |
China | The First Affiliated Hospital of Ningbo University | Ningbo | Zhejiang |
China | The First Affiliated Hospital of Naval Medical University | Shanghai | |
China | The Second Affiliated Hospital of Naval Medical University | Shanghai | |
China | First Affiliated Hospital and Medical College of Soochow University | Suzhou | Jiangsu |
China | Jiangnan University Medical Center | Wuxi | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
Changhai Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 3-year progression-free survival (PFS) | To assess progression-free survival (PFS) including biochemical recurrence-free survival (bPFS), and radiological progression-free survival (RPFS). | Assessment progression-free survival (PFS) at 3 years | |
Secondary | quality of life (QoL) | quality of life (QoL) | through study completion, an average of 3 years | |
Secondary | time to castration-resistant prostate cancer (CRPC) | To assess the time to castration-resistant prostate cancer (CRPC) | through study completion, an average of 3 years | |
Secondary | 5-year overall survival (OS) | To assess the overall survival (OS) | Assessment overall survival (OS) at 5 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05496959 -
177-Lutetium-PSMA Before Stereotactic Body Radiotherapy for the Treatment of Oligorecurrent Prostate Cancer, The LUNAR Study
|
Phase 2 | |
Withdrawn |
NCT04585932 -
Androgen Deprivation Therapy and Apalutamide With or Without Radiation Therapy for the Treatment of Biochemically Recurrent Prostate Cancer, RESTART Study
|
Phase 2 | |
Recruiting |
NCT06389786 -
Accuracy of 18F-rhPSMA-7.3 PET/ MRI for Prediction of Lymph Node Metastasis in Localized High-Risk Prostate Cancer
|
N/A | |
Active, not recruiting |
NCT04190446 -
Radiation Therapy (Hypofractionated Proton Beam Therapy or IMRT) for the Treatment of Recurrent, Oligometastatic Prostate Cancer Following Primary Localized Treatment
|
Phase 2 | |
Recruiting |
NCT06273345 -
OLIGOS: Impact of Treatment on Primary Tumour in Patients With Newly Diagnosed Oligometastatic Neoplasia of the Prostate
|
||
Recruiting |
NCT06205316 -
SBRT Versus Hypofractionated Radiotherapy for Biochemically Recurrent or Oligometastatic Prostate Adenocarcinoma
|
Phase 3 | |
Recruiting |
NCT05053152 -
Testing the Addition of the Drug Relugolix to the Usual Radiation Therapy for Advanced-Stage Prostate Cancer
|
Phase 2 | |
Recruiting |
NCT06369610 -
Risk Stratified De-escalated Hormone Therapy With Radiation Therapy for the Treatment Prostate Cancer
|
Phase 2 |