NCT06350825RecruitingPhase 3
Cytoreductive Prostatectomy Combined With Triple or Dual Systemic Therapy in mHSPC Patients
Evaluating the Efficacy and Safety of Cytoreductive Prostatectomy Combined With Triple or Dual Systemic Therapy in Patients With Metastatic Hormone-Sensitive Prostate Cancer
Source: ClinicalTrials.gov · Last updated 5 Apr 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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)
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 20 Mar 2024
- Start date
- 1 Jan 2016
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Diseases
- Prostate cancer
- NCT number
- NCT06350825
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 200
- From 1 Jan 2016 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of prior local treatment for prostate cancer;
- Difficulty swallowing, chronic diarrhea, intestinal obstruction, and other factors affecting drug intake and absorption;
Other illness
- The surgeon believes the disease is unresectable;
Other
- Life expectancy less than 2 years;
- Active spinal cord compression;
- Refusal to sign the informed consent;
- Investigator believes the individual is not suitable for inclusion.
Who the study is looking for
- 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;
Age in the registry: 18 years to 75 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of Nanjing Medical University Coordinator of this site? Confirm its status | Nanjing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.