Cytoreductive Prostatectomy Combined With Triple or Dual Systemic Therapy in mHSPC Patients

Recruiting now · Phase 3

Conditions studied: Metastatic Prostate Cancer, Therapy, Directly Observed

In brief

To evaluate: The radiographic progression-free survival (rPFS) of metastatic hormone-sensitive prostate cancer (mHSPC) patients treated with androgen deprivation therapy (ADT) + second-generation antiandrogens±chemotherapy combined with cytoreductive prostatectomy (CRP)

Key facts

Study ID

NCT06350825

Run by

The First Affiliated Hospital with Nanjing Medical University

People needed

200

Starts

2016-01-01

Expected to finish

2028-12-31

Last updated by the study team

2024-04-05

Who can join

Age: 18 and older, up to 75. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

• The First Affiliated Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (enrolling)

Full record on ClinicalTrials.gov

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