AzTrials
AzTrials

Localized Prostate CancerPhase 2NCT05010343

Functional Image-Guided Carbon Ion Irradiation With Simultaneous Integrated Boost for Prostate Cancer

A Phase 2 study testing carbon ion irradation and Carbon Ion Irradiation With SIB in people with Localized Prostate Cancer, run by Shanghai Proton and Heavy Ion Center at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 45 to 85 years, men only
Conditions the study is for
Localized Prostate Cancer
What is being tested?
carbon ion irradation and Carbon Ion Irradiation With SIB
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
1 siteChina
Study dates
15 Oct 2020to 1 Jul 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 85 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 11Show fewer
  • 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

Who cannot join

  • No pathologically confirmed adenocarcinoma of the prostate
  • Pelvic lymph node metastasis (N1)
  • Distant metastasis (M1)
  • Previous pelvic radiotherapy
  • Previous prostatectomy

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting

  • Shanghai Proton and Heavy Ion Center

    Shanghai

    Ping Li, 38296666, ping.li@sphic.org.cn

    Qing Zhang, 38296666, qing.zhang@sphic.org.cn

    Recruiting

Other trials in China

About this study

Official title: Functional Image-Guided Carbon Ion Irradiation With Simultaneous Integrated Boost for Prostate Cancer: a Phase II Randomized Controlled Clinical Trial

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.

Read the detailed description

Local recurrences of prostate cancer following radiotherapy often originate from the primary tumor site. Therefore,focal boost to the primary gross tumor has been proposed to increase biochemical disease-free survival (bDFS) without increasing toxicity.

The higher relative biological effectiveness (RBE) and greater cytocidal effect on the intrinsic radiation resistant cancer cells offer carbon ion radiotherapy (CIRT) advantages over conventional radiotherapy. In this study, carbon ion were used to treat localized prostate cancer and simultaneous integrated boost to the gross tumor in the prostate specific membrane antigen (PSMA) PET/CT and multi- parameter MRI.

Being tested
carbon ion irradation, Carbon Ion Irradiation With SIB
Keywords
carbon ion irradiation, Simultaneous Integrated Boost, PSMA PET/CT, mpMRI

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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 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

Study groups in NCT05010343
Study groupRoleWhat they receive
carbon ion irradation groupActive comparatorAll patients will receive carbon ion irradiation with 65.6 GyE in 16 fractions to the prostate with or without seminal vesicle
Receives: Radiation: carbon ion irradation
Carbon Ion Irradiation With SIB groupActive comparatorAll 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
Receives: Radiation: Carbon Ion Irradiation With SIB

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Acute toxicities

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

    Measured: Within 3 months of the start of CIRT

Secondary outcomes (4)

  1. Late toxicities

    Treatment related late toxicity assessed by Radiation Therapy Oncology Group (RTOG) scale

    Measured: 3 months after the completion of CIRT

  2. Biochemical failure free survival

    The prostate specific antigen less than nadir plus 2ng/ml (Phoenix definition)

    Measured: From the complation of CIRT,a median of 5 years

  3. Overall survival

    The time from diagnosis to death from any cause

    Measured: From the diagnosis of prostate cancer,a median of 5 years

  4. Progression free survival

    The time from complation of CIRT to tumor progression or death

    Measured: From the complation of CIRT,a median of 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2021
  2. Study start15 Oct 2020
  3. Primary completion1 Jul 2025 (estimated)
  4. Study completion1 Jul 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
140 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05010343
Sponsor's protocol ID
SPHIC-TR-PCa2020-01
Status last verified
Nov 2021
First submitted
14 Mar 2021
Last updated
15 Nov 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 36348363

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing carbon ion irradation and Carbon Ion Irradiation With SIB in people with Localized Prostate Cancer, run by Shanghai Proton and Heavy Ion Center at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acute toxicities (time frame: Within 3 months of the start of CIRT). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05010343, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in