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NCT05707468Not yet recruiting

Neoadjuvant Radiohormonal Therapy for Oligometastatic Prostate Cancer

Safety and Efficacy Study of Neoadjuvant Radiohormonal Therapy for Oligometastatic Prostate Cancer: a Multi-center Randomized Controlled Clinical Trial

Source: ClinicalTrials.gov · Last updated 20 Feb 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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 (registry)
Not yet recruiting
Study type
Interventional
Enrollment
200 (estimated)
First submitted
15 Dec 2022
Start date
1 May 2024
Primary completion date
1 Mar 2025
Lead sponsor
Changhai Hospital
NCT number
NCT05707468

What you commit to

  • Study type: Interventional
  • Planned participants: 200
  • From 1 May 2024 to the primary completion date, 1 Mar 2025
  • 6 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

  • 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

Lab values

  • 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

Other

  • 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.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 75 years · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (6)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The First Affiliated Hospital of Guangzhou Medical University
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GuangzhouChinaUnknown status
The First Affiliated Hospital of Ningbo University
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NingboChinaUnknown status
The First Affiliated Hospital of Naval Medical University
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ShanghaiChinaUnknown status
The Second Affiliated Hospital of Naval Medical University
Coordinator of this site? Confirm its status
ShanghaiChinaUnknown status
First Affiliated Hospital and Medical College of Soochow University
Coordinator of this site? Confirm its status
SuzhouChinaUnknown status
Jiangnan University Medical Center
Coordinator of this site? Confirm its status
WuxiChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.