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

Sponsor
Shanghai Proton and Heavy Ion Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05106699
Collaborator
(none)
54
1
1
59.7
0.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Radiation: proton plus carbon ion radiation
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
54 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Carbon Ion Boost Followed by Pelvic Proton Radiotherapy for Prostate Cancer With Pelvic Lymph Nodes Metastases: Prospective Phase II Study
Actual Study Start Date :
Jun 8, 2021
Anticipated Primary Completion Date :
May 31, 2025
Anticipated Study Completion Date :
May 31, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Carbon ion followed by Proton radiotherapy

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
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.

Outcome Measures

Primary Outcome Measures

  1. Biochemical relapse free survival [From the start of systemic therapy, a median of 3 years]

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

Secondary Outcome Measures

  1. Progression free survival [From the start of systemic therapy, a median of 3 years]

    The time from start of systemic therapy to tumor progression or death

  2. Overall survival [From the start of systemic therapy, a median of 3 years]

    The time from diagnosis to death from any cause

  3. Metastasis free survival [From the start of systemic therapy, a median of 3 years]

    The time from start of systemic therapy to tumor metastatsis.

  4. Acute toxicities [Within 3 months of the start of particle therapy]

    Treatment related acute toxicity assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03

  5. Late toxicities [3 months after the completion of particle therapy]

    Treatment related late toxicity assessed by Radiation Therapy Oncology Group (RTOG) scale

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years to 85 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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;

Contacts and Locations

Locations

Site City State Country Postal Code
1 Shanghai Proton and Heavy Ion Center Shanghai China

Sponsors and Collaborators

  • Shanghai Proton and Heavy Ion Center

Investigators

  • Study Director: Qing Zhang, M.D., Shanghai Proton and Heavy Ion Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ping Li, Associate chief physician, Shanghai Proton and Heavy Ion Center
ClinicalTrials.gov Identifier:
NCT05106699
Other Study ID Numbers:
  • SPHIC-TR-PCa2021-01
First Posted:
Nov 4, 2021
Last Update Posted:
Nov 4, 2021
Last Verified:
Jun 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ping Li, Associate chief physician, Shanghai Proton and Heavy Ion Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 4, 2021