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Search / Trial NCT05106699

Carbon Ion Followed by Proton Radiotherapy for Prostate Cancer With Pelvic Lymph Nodes Metastases

Launched by SHANGHAI PROTON AND HEAVY ION CENTER · Oct 24, 2021

Trial Information

Current as of August 19, 2025

Recruiting

Keywords

Carbon Ion Proton Prostate Cancer Pelvic Lymph Nodes Metastases

ClinConnect Summary

This clinical trial is studying a new treatment approach for men with prostate cancer that has spread to the pelvic lymph nodes. The treatment combines two types of advanced radiation therapy—carbon ion therapy followed by proton therapy—to see if it can improve outcomes for patients with this specific condition. Researchers want to find out if this combined approach is more effective than the usual treatments currently available.

To participate in the trial, men aged 45 to 85 who have been diagnosed with prostate cancer and have certain characteristics (like no distant cancer spread) may be eligible. Participants can expect to receive targeted radiation therapy while also possibly receiving hormone therapy to help manage their cancer. It's important to note that while this trial is looking for new ways to treat prostate cancer, all participants will be closely monitored for their health throughout the study. If you or a loved one are considering joining this trial, it's vital to discuss it with your healthcare team to understand the potential benefits and risks.

Gender

MALE

Eligibility criteria

  • Inclusion Criteria:
  • Histologically proven initial diagnosis of adenocarcinoma of the prostate;
  • Clinical stage T1-4 N0 M0;
  • Prostatic assessment by multiparametric (mp) MRI;
  • Pelvic lymph node was assessed by PSMA PET/CT and mpMRI;
  • No distant metastasis was proven by PSMA PET/CT;
  • Patients may received neoadjuvant hormonal therapy;
  • 45≤ Age ≤85;
  • Adequate performance status (ECOG 0-1);
  • No previous pelvic radiation therapy (RT);
  • No previous prostatectomy;
  • No previous invasive cancer (within 5 years before the prostate cancer diagnosis);
  • Ability to understand character and individual consequences of the clinical trial;
  • Written informed consent;
  • Exclusion Criteria:
  • No pathologically confirmed adenocarcinoma of the prostate;
  • Distant metastasis (M1);
  • Previous pelvic radiotherapy;
  • Previous prostatectomy;

About Shanghai Proton And Heavy Ion Center

The Shanghai Proton and Heavy Ion Center is a leading clinical trial sponsor dedicated to advancing cancer treatment through innovative radiation therapy techniques. With a focus on proton and heavy ion therapies, the center aims to enhance the precision and effectiveness of cancer care while minimizing side effects. Equipped with state-of-the-art technology and a multidisciplinary team of experts, the center conducts rigorous clinical research to evaluate the safety and efficacy of novel treatment modalities, ultimately striving to improve patient outcomes and contribute to the global body of oncology knowledge.

Locations

Shanghai, , China

Patients applied

0 patients applied

Trial Officials

Qing Zhang, M.D.

Study Director

Shanghai Proton and Heavy Ion Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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