12 Fractions Carbon Ion Radiotherapy for Localized Prostate Cancer

NCT04724577 | Unknown

• 1 other identifier: SPHIC-TR-PCa2019-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The arm of this study is to explore the optimal dose of 12 fractions of carbon ion radiotherapy for prostate cancer in our center.

Conditions

Radiotherapy; Prostate Cancer

Keywords

localized prostate cancer; carbon ion radiotherapy

Outcome Measures

Primary Outcomes (1)

• Acute toxicity

  Treatment related acute toxicity assessed by CTCAE v4.03

  3 months after the completion of CIRT

Secondary Outcomes (3)

• Biochemical failure free survival,bFFS

  From the complation of CIRT,a median of 5 years

• Overall survival

  From the diagnosis of prostate cancer,a median of 5 years

• Progression free survival

  From the complation of CIRT,a median of 5 years

Study Arms (1)

Carbon ion treatment

EXPERIMENTAL

dose escalation study with five dose levels \[54GGyE(Gray equivalent)/12Fx,55.2GyE/12Fx,56.4GyE/12Fx,57.6GyE/12Fx and 58.8GyE/12Fx \].

Radiation: carbon ion radiotherapy

Interventions

carbon ion radiotherapy RADIATION

dose escalation radiotherapy with five levels of dose from 54GyE/12Fx to 58.8GyE/12Fx

Carbon ion treatment

Eligibility Criteria

• Age: 45 Years - 85 Years
• Gender Eligibility Details: Male patients with prostate cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically confirmed adenocarcinoma of prostate
• Stage cT1-3N0M0 localized prostate cancer
• No lymph nodes or distant metastasis
• Age ≥ 45 and \< 85 years of age
• Karnofsky Performance Score ≥70
• 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
• Willing to sign the written informed consent; Informed consent must be signed before the enrollment in the trial

You may not qualify if:

• No pathologically confirmed adenocarcinoma of the prostate
• Pelvic lymph node metastasis (N1)
• 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

Heavy Ion Radiotherapy

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)

Radiotherapy; Therapeutics

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: Principal Investigator

Model Details: dose escalation study for carbon ion radiotherapy in prostate cancer

Study Record Dates

• First Submitted: January 23, 2021
• First Posted: January 26, 2021
• Study Start: December 1, 2019
• Primary Completion: December 1, 2022
• Study Completion: June 1, 2023
• Last Updated: November 19, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)