Carbon Ion Radiotherapy for the Treatment of Localized Prostate Cancer

Prostate Carcinoma Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02739659
• Other study ID #: SPHIC-TR-PCa 2015-01
• Status: Recruiting
• Phase: N/A
• Start date: January 2016
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2021
• Source: Shanghai Proton and Heavy Ion Center
• Contact: Ping Li, Dr.
• Email: ping.li[@]sphic.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this research project is to assess the feasibility and safety of carbon-ion radiotherapy (CIRT) for the treatment of in Chinese localized prostate cancer

Description:

The purpose of this study is to determine the maximal tolerated dose (MTD) of CIRT in the treatment of localized prostate cancer and to evaluate the efficacy of such treatment at the MTD. Participants will be treated with CIRT with escalating dose regimens to evaluate the maximal tolerated dose (MTD) in terms of acute and subacute toxicity observed during and within 6 months after the completion of CIRT. Once the MTD for localized prostate cancer is determined, the MTD will be used as the recommended dose to patients fulfilling the inclusion criteria in the Phase II part of the trial.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 73
• Est. completion date: December 31, 2024
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 85 Years

Eligibility

Inclusion Criteria:

• Pathologically confirmed adenocarcinoma of the prostate
• No lymph node and distant metastasis
• Age = 20 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)except for skin non-melanoma cancer
• 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

Exclusion Criteria:

• No pathologically confirmed adenocarcinoma of the prostate
• Pelvic lymph node metastasis (N1)
• Distant metastasis (M1)
• Urinary obstructive symptoms (IPSS > 20)
• Previous pelvic radiotherapy
• Previous prostatectomy
• Severe systemic disorders
• Concomitant disorders including: chronic urinary or intestinal inflammatory conditions (for example, ulcerous recto-colitis, Crohn disease), anti-coagulant treatment (warfarin, heparin)
• Previous malignancy except for skin non-melanoma cancer or 3-year disease free interval from previous malignancy like non muscle invasive bladder cancer
• Non conformity of the radiotherapy dose distribution when compared to the dose constraints
• Psychiatric disorders or any other condition that can make unreliable the informed consent

Related Conditions & MeSH terms

• Prostate Carcinoma
• Prostatic Neoplasms

Intervention

Device:
• carbon-ion radiotherapy

Locations

Country	Name	City	State
China	Shanghai Proton and Heavy Ion Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Proton and Heavy Ion Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0		From the date of CIRT to 6 months after the completion of CIRT, up to 6 months
Secondary	Overall survival of all patients		From the diagnosis of localized prostate, a median of 2 years
Secondary	biochemical failure-free survival,bFFS		From the completion of CIRT, a median of 2 years
Secondary	Progression-free survival of all patients		From the completion of CIRT, a median of 2 years