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

NCT05106699 | Recruiting

• 1 other identifier: SPHIC-TR-PCa2021-01
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

The present of clinically pelvic lymph node positive (cN1) represent one of the most important prognostic factors for recurrence and cancer-specific mortality of prostate cancer patients. Approximately 12% of prostate cancer patients present with cN1 disease at the time of diagnosis. Furthermore, with the advent of more sensitive advance diagnostic imaging techniques, such as PSMA PET/CT, the likelihood that pelvic nodes will be found earlier and more frequently. Unfortunately, The optimal treatment for patients with cN1 still remains unclear. Androgen deprivation therapy (ADT) is the cornerstone of prostate cancer with pelvic lymph node metastasis. Some retrospective and database studies have shown that addition of local radiotherapy (RT) to ADT improve the treatment outcome. The 2022 NCCN guideline recommend RT combined with 2 to 3 years ADT in patients with initially diagnosed cN1 prostate cancer who have a life expectancy greater than 5 years.

Conditions

Prostate Cancer

Keywords

Carbon ion; Proton; prostate cancer; pelvic lymph nodes metastases

Outcome Measures

Primary Outcomes (1)

• Biochemical relapse free survival

  The prostate specific antigen less than nadir plus 2ng/ml (Phoenix definition)

  From the start of systemic therapy, a median of 3 years

Secondary Outcomes (5)

• Progression free survival

  From the start of systemic therapy, a median of 3 years

• Overall survival

  From the start of systemic therapy, a median of 3 years

• Metastasis free survival

  From the start of systemic therapy, a median of 3 years

• Acute toxicities

  Within 3 months of the start of particle therapy

• Late toxicities

  3 months after the completion of particle therapy

Study Arms (1)

Carbon ion followed by Proton radiotherapy

EXPERIMENTAL

All patients received whole pelvis and prostate region radiotherapy. The dose to metastatic LN was escalated using simultaneous integrated boost (SIB) technique.

Radiation: proton plus carbon ion radiation

Interventions

proton plus carbon ion radiation RADIATION

All patients received whole pelvis and prostate region proton irradiation of 46 GyE in 23 fractionsfollowed by localized carbon ion irradiation of 32GyE in 8 fractions to the prostate region. The dose to metastatic LN was escalated using simultaneous integrated boost (SIB) technique. The dose was 60-62.1GyE in 23 fractions as much as dose constraints. All patients will be recommened receive 2-3 years endocrine therapy.

Carbon ion followed by Proton radiotherapy

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• ≤ 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;

You may not qualify if:

• No pathologically confirmed adenocarcinoma of the prostate;
• Distant metastasis (M1);
• Previous pelvic radiotherapy;
• Previous prostatectomy;

Sponsors & Collaborators

• Shanghai Proton and Heavy Ion Center: lead

Study Sites (1)

Shanghai Proton and Heavy Ion Center

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Protons

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cations, Monovalent; Cations; Ions; Electrolytes; Inorganic Chemicals; Hydrogen; Elements; Gases; Nucleons; Elementary Particles; Physical Phenomena

Study Officials

• Qing Zhang, M.D.

  Shanghai Proton and Heavy Ion Center

  STUDY DIRECTOR

Central Study Contacts

Ping Li, M.D.

CONTACT

+86-021-38296666; ping.li@sphic.org.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate chief physician

Study Record Dates

• First Submitted: October 24, 2021
• First Posted: November 4, 2021
• Study Start: June 8, 2021
• Primary Completion: May 31, 2025
• Study Completion (Estimated): May 31, 2026
• Last Updated: November 4, 2021

Record last verified: 2021-06

Locations

CN (1)