Cytoreductive Prostatectomy Combined With Triple or Dual Systemic Therapy in mHSPC Patients

Launched by THE FIRST AFFILIATED HOSPITAL WITH NANJING MEDICAL UNIVERSITY · Mar 29, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a treatment approach for men with metastatic hormone-sensitive prostate cancer (mHSPC). The researchers want to see if combining a surgery called cytoreductive prostatectomy (where the prostate gland is removed) with hormone therapy and other medications can help patients live longer without their cancer getting worse. This trial is currently looking for participants aged between 18 and 75 who have been diagnosed with prostate cancer that has spread to other parts of the body.

To be eligible for the trial, participants must be male and have a confirmed diagnosis of prostate cancer with evidence of metastasis, which means the cancer has spread beyond the prostate. They should not have received any local treatments, like radiation, prior to joining the study, and their doctor must believe that their cancer can be surgically removed. Participants in the trial will receive a combination of treatments and will be monitored closely for how well the therapy works over time. It's important for potential participants to discuss the trial with their healthcare team to understand if it's a good option for them.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Male aged ≥18 and ≤75;
• • 2. Histologically confirmed prostate adenocarcinoma;
• • 3. Evidence of metastasis confirmed by magnetic resonance imaging (MRI)/computed tomography (CT) scan, bone scan, or histology;
• • 4. Clinical stage M1a (distant lymph node positive), M1b (bone metastasis), or M1c (visceral organ metastasis);
• • 5. Prostate cancer has not received local treatment (e.g., prostate radiotherapy, cryotherapy, etc.);
• • 6. The surgeon believes the prostate can be removed;
• Exclusion Criteria:
• • 1. The surgeon believes the disease is unresectable;
• • 2. Life expectancy less than 2 years;
• • 3. Active spinal cord compression;
• • 4. History of prior local treatment for prostate cancer;
• • 5. Difficulty swallowing, chronic diarrhea, intestinal obstruction, and other factors affecting drug intake and absorption;
• • 6. Refusal to sign the informed consent;
• • 7. Investigator believes the individual is not suitable for inclusion.