Neoadjuvant Radiohormonal Therapy for Oligometastatic Prostate Cancer

Launched by CHANGHAI HOSPITAL · Jan 28, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating new treatment options for men with oligometastatic prostate cancer, which means their cancer has spread to a limited number of places, like a few bones or lymph nodes. The researchers want to compare two different approaches: one involves using targeted radiation and hormone therapy before surgery, while the other involves a combination of hormone therapy and a specific medication called abiraterone, followed by robotic surgery to remove the prostate. The goal is to see which method is safer and more effective for patients.

To participate in the trial, men must be diagnosed with prostate cancer that meets certain criteria, such as having a limited number of metastases and expected to live for more than five years. They should be in good overall health and willing to provide consent to join the study. Not everyone will qualify; for example, those who have received previous cancer treatments, have certain medical conditions, or have had recent surgeries may be excluded. Participants can expect close monitoring and care throughout the trial to ensure their safety and well-being.

Gender

MALE

Eligibility criteria

• 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.