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

  • STATUS
    Recruiting
  • End date
    Jul 1, 2028
  • participants needed
    140
  • sponsor
    Shanghai Proton and Heavy Ion Center
Updated on 23 November 2021

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.

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.

Details
Condition Localized Prostate Cancer
Treatment carbon ion irradation, Carbon Ion Irradiation With SIB
Clinical Study IdentifierNCT05010343
SponsorShanghai Proton and Heavy Ion Center
Last Modified on23 November 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note