Cytoreductive Prostatectomy Combined With Triple or Dual Systemic Therapy in mHSPC Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cytoreductive prostatectomy or brachytherapy, ADT+second-generation antiandrogens ± chemotherapy.
- Who it may be relevant to
- Registry conditions: Metastatic Prostate Cancer, Therapy, Directly Observed. Basic parameters: 18 years — 75 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluating the Efficacy and Safety of Cytoreductive Prostatectomy Combined With Triple or Dual Systemic Therapy in Patients With Metastatic Hormone-Sensitive Prostate Cancer
Overview
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)
Detailed description
To investigate the multimodality approaches for mHSPC
Interventions
- Procedure Cytoreductive prostatectomy or brachytherapy
local treatment+SOC for metastatic prostate cancer - Drug ADT+second-generation antiandrogens ± chemotherapy
SOC(Triplet or doublet therapy) for mHSPC
Primary outcome measures
- rPFS [Time frame: 3 year]
Secondary outcome measures (1)
- Safety of CRP in mHSPC patients [Time frame: until one year after the local therapy]
Eligibility criteria
Inclusion criteria
- 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;
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- The First Affiliated Hospital of Nanjing Medical University — Nanjing
Identifiers
NCT: NCT06350825 · 2023-SR-543