Health Trials

CytoREductive prostAtectomy for Poly-metastatic Hormone sensiTIVE Prostate Cancer

ConditionProstate Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-85
SponsorRenJi Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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;

Contraindication to CT/MRI examination;

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);

Trial design

Treatments tested in this trial

  • Systemic Chemohormonal Therapy
  • Systemic Hormonal Therapy
  • Cytoreductive Prostatectomy
  • Postoperative Adjuvant Radiotherapy

Treatment groups

192 Participants
are divided into 2 treatment groups

Sponsors and collaborators

RenJi Hospital

Lead sponsor

Source ClinicalTrials.gov