12 Fractions Carbon Ion Radiotherapy for Localized Prostate Cancer

• Sponsor: Shanghai Proton and Heavy Ion Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04724577
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 42
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Radiotherapy; Prostate Cancer	Radiation: carbon ion radiotherapy	N/A

Detailed Description

The radiation dose of 51.6GyE in 12 fractions is currently widely used in Japan, and clinical studies of 51.6GyE/12Fx have also been carried out for SBRT. There are some differences in equipment and carbon ion treatment planning system used between Japan and our center. Therefore, we designed this phase I clinical study to explore the optimal dose of 12 fractions of carbon ion radiotherapy for prostate cancer.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: dose escalation study for carbon ion radiotherapy in prostate cancerdose escalation study for carbon ion radiotherapy in prostate cancer
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase I Study on Carbon Ion Radiotherapy in 12 Fractions for Localized Prostate Cancer
• Actual Study Start Date: Dec 1, 2019
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Carbon ion treatment 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; dose escalation radiotherapy with five levels of dose from 54GyE/12Fx to 58.8GyE/12Fx

Outcome Measures

Primary Outcome Measures

1. Acute toxicity [3 months after the completion of CIRT]

   Treatment related acute toxicity assessed by CTCAE v4.03

Secondary Outcome Measures

1. Biochemical failure free survival,bFFS [From the complation of CIRT,a median of 5 years]

   The PSA less than nadir plus 2ng/ml

2. Overall survival [From the diagnosis of prostate cancer,a median of 5 years]

   The time from diagnosis to death from any cause

3. Progression free survival [From the complation of CIRT,a median of 5 years]

   The time from complation of CIRT to tumor progression or death

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• 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

Exclusion Criteria:

• No pathologically confirmed adenocarcinoma of the prostate

• Pelvic lymph node metastasis (N1)

• 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

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ping Li, Principal Investigator, Shanghai Proton and Heavy Ion Center
• ClinicalTrials.gov Identifier: NCT04724577
• Other Study ID Numbers: SPHIC-TR-PCa2019-01
• First Posted: Jan 26, 2021
• Last Update Posted: Nov 19, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ping Li, Principal Investigator, Shanghai Proton and Heavy Ion Center: localized prostate cancer; carbon ion radiotherapy
• Additional relevant MeSH terms: Prostatic Neoplasms

Study Results

No Results Posted as of Nov 19, 2021