Carbon ion and proton therapy for prostate cancer with lymph node metastases

Carbon Ion Boost Followed by Pelvic Proton Radiotherapy for Prostate Cancer With Pelvic Lymph Nodes Metastases: Prospective Phase II Study

This study tests if combining carbon ion and proton therapy can help men with prostate cancer that has spread to lymph nodes do better than with standard treatments.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 54 (estimated)
• Ages: 45 Years to 85 Years
• Sex: Male
• Sponsor: Shanghai Proton and Heavy Ion Center (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Shanghai)
• Trial ID: NCT05106699 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of combining carbon ion and proton radiotherapy for patients diagnosed with prostate cancer that has spread to pelvic lymph nodes. The study aims to determine if this advanced radiation therapy can improve treatment outcomes compared to standard approaches. Patients will undergo imaging assessments to confirm their cancer stage and suitability for the treatment. The trial focuses on patients who have not received prior pelvic radiation or surgery and are within a specific age range.

Who should consider this trial

Good fit: Ideal candidates are men aged 45 to 85 with histologically confirmed adenocarcinoma of the prostate and clinical stage T1-4 N0 M0.

Not a fit: Patients with distant metastasis, previous pelvic radiation therapy, or prior prostatectomy will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve survival rates and reduce recurrence in prostate cancer patients with pelvic lymph node metastases.

How similar studies have performed: While there have been studies on radiotherapy for prostate cancer, the combination of carbon ion and proton therapy is a novel approach that has not been extensively tested.

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;

Where this trial is running

Shanghai

• Shanghai Proton and Heavy Ion Center — Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Ping Li, M.D.

Conditions Prostate Cancer; Carbon ion; Proton; prostate cancer; pelvic lymph nodes metastases