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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Radiation: proton plus carbon ion radiation

• Study Type: Interventional
• Enrollment (Anticipated): 54
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ping Li, M.D.; Phone Number: +86-021-38296666; Email: ping.li@sphic.org.cn

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Shanghai Proton and Heavy Ion Center
    • Contact: Ping Li; Phone Number: +86-021-38296666; Email: ping.li@sphic.org.cn
    • Contact: Qing Zhang; Email: qing.zhang@sphic.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression free survival	The time from start of systemic therapy to tumor progression or death	From the start of systemic therapy, a median of 3 years
Overall survival	The time from diagnosis to death from any cause	From the start of systemic therapy, a median of 3 years
Metastasis free survival	The time from start of systemic therapy to tumor metastatsis.	From the start of systemic therapy, a median of 3 years
Acute toxicities	Treatment related acute toxicity assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03	Within 3 months of the start of particle therapy
Late toxicities	Treatment related late toxicity assessed by Radiation Therapy Oncology Group (RTOG) scale	3 months after the completion of particle therapy

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2021
• Primary Completion (Anticipated): May 31, 2025
• Study Completion (Anticipated): May 31, 2026

Study Registration Dates

• First Submitted: October 24, 2021
• First Submitted That Met QC Criteria: October 24, 2021
• First Posted (Actual): November 4, 2021

Study Record Updates

• Last Update Posted (Actual): November 4, 2021
• Last Update Submitted That Met QC Criteria: October 24, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: prostate cancer; Proton; Carbon ion; pelvic lymph nodes metastases
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Neoplastic Processes; Prostatic Neoplasms; Neoplasm Metastasis; Lymphatic Metastasis
• Other Study ID Numbers: SPHIC-TR-PCa2021-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No