Clinical trial NCT05010343: Functional Image-Guided Carbon Ion Irradiation With Simultaneous Integrated Boost for Prostate Cancer
Official title: Functional Image-Guided Carbon Ion Irradiation With Simultaneous Integrated Boost for Prostate Cancer: a Phase II Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Localized Prostate Cancer
Keywords: carbon ion irradiation
Simultaneous Integrated Boost
PSMA PET/CT
mpMRI
Lead sponsor: Shanghai Proton and Heavy Ion Center
Sponsor class: OTHER
First posted: 2021-08-18
Enrollment: 140
Sex: MALE
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Acute toxicities
timeFrame: Within 3 months of the start of CIRT
Secondary outcomes:
measure: Late toxicities
timeFrame: 3 months after the completion of CIRT
measure: Biochemical failure free survival
timeFrame: From the complation of CIRT,a median of 5 years
measure: Overall survival
timeFrame: From the diagnosis of prostate cancer,a median of 5 years
measure: Progression free survival
timeFrame: From the complation of CIRT,a median of 5 years
Other outcomes:
measure: The quality of life-International Prostate Symptom Score (IPSS)
timeFrame: From the complation of CIRT, a median of 5 years
measure: The quality of life-Expanded Prostate Cancer Index Composite (EPIC)
timeFrame: From the complation of CIRT, a median of 5 years
Locations:
city: Shanghai
country: China
facility: Shanghai Proton and Heavy Ion Center
Study officials:
References:
citation: 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.