Combining surgery with systemic therapy for advanced 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

This study is testing whether combining surgery with a new type of treatment can help people with advanced prostate cancer feel better compared to standard care.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 192 (estimated)
• Ages: 18 Years to 85 Years
• Sex: Male
• Sponsor: RenJi Hospital (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy, radiation
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06306612 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to compare the effectiveness and safety of systemic therapy combined with cytoreductive prostatectomy against standard care for patients with de novo poly-metastatic hormone-sensitive prostate cancer. Participants will receive systemic therapy alongside surgery, and researchers will evaluate the clinical benefits, safety, and potential prognostic factors associated with this combined approach. The study also seeks to understand how molecular imaging correlates with treatment efficacy. By analyzing these factors, the trial hopes to identify which patients may benefit the most from this treatment strategy.

Who should consider this trial

Good fit: Ideal candidates are men aged 18-85 with confirmed adenocarcinoma of the prostate and multiple metastatic disease.

Not a fit: Patients with only regional lymph node metastases or those who have received prior treatment for prostate cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved outcomes for patients with advanced prostate cancer.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in combining systemic therapies with surgical interventions for advanced cancers.

Eligibility criteria

Inclusion Criteria:

1. Fully understand the purpose of this trial and sign a written informed consent;
2. Men aged 18-85 years;
3. have histologically or cytologically confirmed adenocarcinoma of the prostate;
4. 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.
5. At the investigator's discretion, patients must meet the indications for ADT and docetaxel;
6. Patients have not received any prior local or systemic therapy for prostate cancer primary or metastasis.
7. Eastern Cooperative Oncology Group (ECOG) score of 0-1;
8. 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)
9. Serum alanine aminotransferase and/or aspartate aminotransferase ≤ 1.5 x Upper limit of normal (ULN), total bilirubin ≤ ULN, creatinine ≤ 2.0 x ULN.

Exclusion Criteria:

1. 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);
2. Known hypersensitivity to any of the investigational drugs, or excipients in the preparations;
3. Contraindication to CT/MRI examination;
4. 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);
5. uncontrolled hypertension as evidenced by a resting systolic blood pressure ≥ 160 mm Hg or diastolic blood pressure ≥ 100 mm Hg after treatment
6. History of prior malignancy, except basal cell or cutaneous squamous cell carcinoma in complete remission;
7. History of gastrointestinal disorders or surgery expected to significantly interfere with the absorption of study drug(s);
8. Active acute and chronic viral hepatitis, known HIV infection;
9. 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;
10. 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;
11. Inability to swallow oral medications;
12. A close interest in the research center.

Where this trial is running

Shanghai, Shanghai Municipality

• Renji Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Principal investigator: Yinjie Zhu, Dr. — RenJi Hospital
• Study coordinator: Liang Dong

Conditions Prostate Cancer