Tests radiation and hormone therapy before surgery for prostate cancer spread
Compares pre-surgery radiation and hormone treatment with hormone plus abiraterone in men with limited spread.
Plain-language title generated from the registry record
Registry title: Neoadjuvant Radiohormonal Therapy for Oligometastatic Prostate Cancer
Key facts
- Where
- Guangzhou, Ningbo, Shanghai, Suzhou, and Wuxi, ChinaSee the 6 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT05707468, who can take part
Where in China
- The First Affiliated Hospital of Guangzhou Medical UniversityGuangzhou, ChinaNo longer taking part
- The First Affiliated Hospital of Ningbo UniversityNingbo, ChinaNo longer taking part
- The First Affiliated Hospital of Naval Medical UniversityShanghai, ChinaNo longer taking part
- The Second Affiliated Hospital of Naval Medical UniversityShanghai, ChinaNo longer taking part
- First Affiliated Hospital and Medical College of Soochow UniversitySuzhou, ChinaNo longer taking part
- Jiangnan University Medical CenterWuxi, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Changhai Hospital
- Trial code
- NCT05707468
- Record updated
- 20 February 2024
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: 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; Severe or active comorbidities likely to impact the advisability of radiotherapy; Patients with other malignancies and acute or chronic infections such as human immunodeficiency virus (HIV) (+), hepatitis C virus (HCV) (+) and/or positive syphilis; 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 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 who have visceral metastases; 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.