NCT06306612Recruiting
CytoREductive prostAtectomy for Poly-metastatic Hormone sensiTIVE Prostate Cancer
Systemic Therapy Combined With Cytoreductive Prostatectomy for the Treatment of de Novo Poly-metastatic Hormone Sensitive Prostate Cancer: A Prospective, Open-label Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 11 Aug 2026
Brief summary (registry, in English)
The goal of this clinical trial is to compare systemic therapy combined with cytoreductive prostatectomy with standard of care (SOC) in de novo poly-metastatic hormone sensitive prostate cancer (de novo pmHSPC). The main questions it aims to answer are: 1. To explore the clinical benefit and safety of systemic therapy combined with cytoreductive prostatectomy for patients with de novo pmHSPC. 2. To explore the characteristics of the subgroup of patients who could benefit more from the above treatment. 3. To explore the relationship between stage efficacy and clinical prognosis. 4. To explore the correlation between molecular imaging such as PSMA-PET/CT and its changes with treatment efficacy. Participants will undergo systemic therapy combined with cytoreductive prostatectomy. Researchers will compare systemic therapy combined with cytoreductive prostatectomy with SOC to see the pros and cons of the two strategies.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 192 (estimated)
- First submitted
- 19 Feb 2024
- Start date
- 21 Mar 2024
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- RenJi Hospital
- Diseases
- Prostate cancer
- NCT number
- NCT06306612
What you commit to
- Study type: Interventional
- Planned participants: 192
- From 21 Mar 2024 to the primary completion date, 31 Dec 2028
- 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
- Prior therapy: ADT, second-generation androgen receptor inhibitors, CYP17 enzyme inhibitors, any chemotherapy or immunotherapy for prostate cancer, radiotherapy (external radiation radiotherapy, brachytherapy, or radiopharmaceuticals);
- Known hypersensitivity to any of the investigational drugs, or excipients in the preparations;
- Any of the following conditions within 6 months prior to randomization: stroke, myocardial infarction, severe or unstable angina, coronary or peripheral artery bypass grafting, or congestive heart failure (New York Heart Association cardiac function class III or IV);
- Prior (28 days prior to initiation of study drug or 5 half-lives of investigational therapy from a prior study, whichever is longer) or concurrent participation in another clinical study of study drug;
- Inability to swallow oral medications;
Other illness
- uncontrolled hypertension as evidenced by a resting systolic blood pressure ≥ 160 mm Hg or diastolic blood pressure ≥ 100 mm Hg after treatment
- History of prior malignancy, except basal cell or cutaneous squamous cell carcinoma in complete remission;
- History of gastrointestinal disorders or surgery expected to significantly interfere with the absorption of study drug(s);
- Active acute and chronic viral hepatitis, known HIV infection;
- Any other serious or unstable medical condition or condition that may interfere with their participation in the study or the evaluation of study results or may jeopardize the safety of the trial and other conditions;
Other
- Contraindication to CT/MRI examination;
- A close interest in the research center.
Who the study is looking for
- Fully understand the purpose of this trial and sign a written informed consent;
- Men aged 18-85 years;
- have histologically or cytologically confirmed adenocarcinoma of the prostate;
- Have multiple metastatic disease, defined as follows: according to RECIST v1.1, metastatic disease was defined as metastatic foci detected on bone scans or measurable lymph nodes or soft tissue or visceral lesions above the aortic bifurcation. Lymph nodes were defined as measurable if their short-axis diameter was ≥15 mm; soft tissue/visceral lesions were defined as measurable if their long-axis diameter was ≥10 mm. and total number of metastatic lesions ≥ 5. Patients with only regional lymph node metastases (N1, below the aortic bifurcation) were not eligible for the study.
- At the investigator's discretion, patients must meet the indications for ADT and docetaxel;
- Patients have not received any prior local or systemic therapy for prostate cancer primary or metastasis.
- Eastern Cooperative Oncology Group (ECOG) score of 0-1;
- Blood count at screening: hemoglobin ≥ 9.0 g/dL, absolute neutrophil count ≥ 1.5 x 10\^9/L, and platelet count ≥ 100 x 10\^9/L (patient has not received any colony-stimulating factor within 4 weeks or a transfusion or blood product within 7 days prior to blood collection)
- Serum alanine aminotransferase and/or aspartate aminotransferase ≤ 1.5 x Upper limit of normal (ULN), total bilirubin ≤ ULN, creatinine ≤ 2.0 x ULN.
Age in the registry: 18 years to 85 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 |
|---|---|---|---|
| Renji Hospital Shanghai Jiao Tong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.