Carbon Ion Radiotherapy for the Treatment of Localized Prostate Cancer

Not Applicable

Recruiting

• Conditions: Prostate Carcinoma
• Interventions: Device: carbon-ion radiotherapy

• Registration Number: NCT02739659
• Lead Sponsor: Shanghai Proton and Heavy Ion Center

Brief 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

Detailed 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.

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-04-07
• Study First Submitted QC: 2016-04-11
• Study First Posted: 2016-04-15
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-12
• Last Update Posted: 2021-11-19
• Primary Completion: 2022-12-01
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 73

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
carbon-ion radiotherapy	carbon-ion radiotherapy	Five dose levels \[59.2 GyE(Gray equivalent)/16Fx, 60.8 GyE/16Fx, 62.4 GyE/16Fx, 64.0 GyE/16Fx and 65.6 GyE/16Fx\] are planned within the Phase I part. After the recommended dose (RD), i.e., MTD, is determined or if the treatments to 65.6 GyE/16Fx are safely delivered, the recommended dose (or 65.6 GyE/16Fx) will be the prescribed dose in the Phase II part of the study.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Progression-free survival of all patients	From the completion of CIRT, a median of 2 years
biochemical failure-free survival，bFFS	From the completion of CIRT, a median of 2 years
Overall survival of all patients	From the diagnosis of localized prostate, a median of 2 years

Trial Locations

Locations (1)

Shanghai Proton and Heavy Ion Center; 🇨🇳 Shanghai, Shanghai, China