NCT05010343

Brief Summary

This is a phase II randomized controlled clinical trial to assess the toxicities and clinical efficacy of prostate specific membrane antigen (PSMA) positron emission tomography / computed tomography (PET/CT) and multi- parameter Magnetic Resonance Imaging (MRI) guided simultaneous integrated boost for prostate cancer.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P75+ for phase_2

Timeline
26mo left

Started Oct 2020

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress72%
Oct 2020Jul 2028

Study Start

First participant enrolled

October 15, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 14, 2021

Completed
5 months until next milestone

First Posted

Study publicly available on registry

August 18, 2021

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Expected
Last Updated

November 15, 2021

Status Verified

November 1, 2021

Enrollment Period

4.7 years

First QC Date

March 14, 2021

Last Update Submit

November 12, 2021

Conditions

Localized Prostate Cancer

Keywords

carbon ion irradiationSimultaneous Integrated BoostPSMA PET/CTmpMRI

Outcome Measures

Primary Outcomes (1)

  • Acute toxicities

    Treatment related acute toxicity assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03

    Within 3 months of the start of CIRT

Secondary Outcomes (4)

  • Late toxicities

    3 months after the completion of CIRT

  • Biochemical failure free survival

    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

Other Outcomes (2)

  • The quality of life-International Prostate Symptom Score (IPSS)

    From the complation of CIRT, a median of 5 years

  • The quality of life-Expanded Prostate Cancer Index Composite (EPIC)

    From the complation of CIRT, a median of 5 years

Study Arms (2)

carbon ion irradation group

ACTIVE COMPARATOR

All patients will receive carbon ion irradiation with 65.6 GyE in 16 fractions to the prostate with or without seminal vesicle

Radiation: carbon ion irradation

Carbon Ion Irradiation With SIB group

ACTIVE COMPARATOR

All patients will receive carbon ion irradiation with 65.6 GyE in 16 fractions to the prostate with or without seminal vesicle, and with simultaneous integrated boost (SIB) to the gross tumor in the PSMA PET/CT and mpMRI

Radiation: Carbon Ion Irradiation With SIB

Interventions

carbon ion irradationRADIATION

All patients will receive carbon ion irradiation with 65.6 GyE in 16 fractions to the prostate with or without seminal vesicle

carbon ion irradation group
Carbon Ion Irradiation With SIBRADIATION

All patients will receive carbon ion irradiation with 65.6 GyE in 16 fractions to the prostate with or without seminal vesicle, and with simultaneous integrated boost (SIB) to the gross tumor in the PSMA PET/CT and mpMRI

Carbon Ion Irradiation With SIB group

Eligibility Criteria

Age45 Years - 85 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pathologically confirmed adenocarcinoma of prostate
  • Stage cT1-3N0M0 localized prostate cancer
  • performed PSMA PET/CT and mpMRI before treatment
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Proton and Heavy Ion Center

Shanghai, China

RECRUITING

Related Publications (1)

  • Hu W, Li P, Hong Z, Guo X, Pei Y, Zhang Z, Zhang Q. Functional imaging-guided carbon ion irradiation with simultaneous integrated boost for localized prostate cancer: study protocol for a phase II randomized controlled clinical trial. Trials. 2022 Nov 8;23(1):934. doi: 10.1186/s13063-022-06798-5.

    PMID: 36348363DERIVED

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 14, 2021

First Posted

August 18, 2021

Study Start

October 15, 2020

Primary Completion

July 1, 2025

Study Completion (Estimated)

July 1, 2028

Last Updated

November 15, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)