NCT02739659

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
73

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 15, 2016

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

November 19, 2021

Status Verified

November 1, 2021

Enrollment Period

6.9 years

First QC Date

April 7, 2016

Last Update Submit

November 12, 2021

Conditions

Prostate Carcinoma

Keywords

prostate carcinomacarbon-ion radiotherapyefficacytoxicity

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Overall survival of all patients

    From the diagnosis of localized prostate, a median of 2 years

  • biochemical failure-free survival，bFFS

    From the completion of CIRT, a median of 2 years

  • Progression-free survival of all patients

    From the completion of CIRT, a median of 2 years

Study Arms (1)

carbon-ion radiotherapy

EXPERIMENTAL

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.

Device: carbon-ion radiotherapy

Interventions

carbon-ion radiotherapyDEVICE
carbon-ion radiotherapy

Eligibility Criteria

Age20 Years - 85 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Proton and Heavy Ion Center

Shanghai, Shanghai Municipality, 201321, China

RECRUITING

Related Publications (1)

  • Zhang Y, Li P, Yu Q, Wu S, Chen X, Zhang Q, Fu S. Preliminary exploration of clinical factors affecting acute toxicity and quality of life after carbon ion therapy for prostate cancer. Radiat Oncol. 2019 Jun 4;14(1):94. doi: 10.1186/s13014-019-1303-3.

    PMID: 31164172DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Heavy Ion Radiotherapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeutics

Study Officials

  • Qing Zhang, Dr.

    Shanghai Proton and Heavy Ion Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ping Li, Dr.

CONTACT

ping.li@sphic.org.cn

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
DIRECTOR

Study Record Dates

First Submitted

April 7, 2016

First Posted

April 15, 2016

Study Start

January 1, 2016

Primary Completion

December 1, 2022

Study Completion

December 31, 2024

Last Updated

November 19, 2021

Record last verified: 2021-11

Locations

CN(1)