Combining surgery with hormone therapy for advanced prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of cytoreductive prostatectomy combined with androgen deprivation therapy and second-generation antiandrogens, with or without chemotherapy, in patients with metastatic hormone-sensitive prostate cancer. The primary goal is to assess radiographic progression-free survival in these patients. By employing a multimodal treatment approach, the study aims to improve outcomes for individuals with advanced prostate cancer who have not yet received local treatment. Participants will undergo imaging to confirm metastasis and will be closely monitored throughout the treatment process.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Male aged ≥18 and ≤75;
2. Histologically confirmed prostate adenocarcinoma;
3. Evidence of metastasis confirmed by magnetic resonance imaging (MRI)/computed tomography (CT) scan, bone scan, or histology;
4. Clinical stage M1a (distant lymph node positive), M1b (bone metastasis), or M1c (visceral organ metastasis);
5. Prostate cancer has not received local treatment (e.g., prostate radiotherapy, cryotherapy, etc.);
6. The surgeon believes the prostate can be removed;

Exclusion Criteria:

1. The surgeon believes the disease is unresectable;
2. Life expectancy less than 2 years;
3. Active spinal cord compression;
4. History of prior local treatment for prostate cancer;
5. Difficulty swallowing, chronic diarrhea, intestinal obstruction, and other factors affecting drug intake and absorption;
6. Refusal to sign the informed consent;
7. Investigator believes the individual is not suitable for inclusion.

Where it's running

• The First Affiliated Hospital of Nanjing Medical University
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Principal investigator: Lixin Hua, M.D. — The First Affiliated Hospital with Nanjing Medical University
• Study coordinator: Lixin Hua, M.D.
• Email: hlx5858@163.com
• Phone: 13072564303

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.