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

RECRUITINGPhase 3Sponsored by The First Affiliated Hospital with Nanjing Medical University
Actively Recruiting
PhasePhase 3
SponsorThe First Affiliated Hospital with Nanjing Medical University
Started2016-01-01
Est. completion2027-12-31
Eligibility
Age18 Years – 75 Years
SexMALE
Healthy vol.Accepted

Summary

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)

Eligibility

Age: 18 Years – 75 YearsSex: MALEHealthy volunteers accepted
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.

Conditions3

CancerMetastatic Prostate CancerTherapy, Directly Observed

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