Combining surgery with hormone therapy for advanced prostate cancer

Evaluating the Efficacy and Safety of Cytoreductive Prostatectomy Combined With Triple or Dual Systemic Therapy in Patients With Metastatic Hormone-Sensitive Prostate Cancer

This study is testing if combining surgery with hormone therapy and possibly chemotherapy can help men with advanced prostate cancer live longer without their cancer getting worse.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Male
• Sponsor: The First Affiliated Hospital with Nanjing Medical University (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT06350825 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are males aged 18 to 75 with histologically confirmed metastatic prostate adenocarcinoma who have not received prior local treatment.

Not a fit: Patients with unresectable disease or those with a life expectancy of less than two years may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve survival rates and quality of life for patients with metastatic prostate cancer.

How similar studies have performed: While multimodal approaches in cancer treatment have shown promise, this specific combination of therapies in metastatic hormone-sensitive prostate cancer is relatively novel.

Eligibility criteria

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 this trial is running

Nanjing, Jiangsu

• 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.

Conditions: Metastatic Prostate Cancer, Therapy, Directly Observed, prostate cancer, cytoreductive prostatectomy