Two-fraction Proton Therapy With MRI Guidance for Prostate Cancer: A Phase II Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
AgeNot listed
SponsorHong Kong Sanatorium & Hospital
About this trial
This study is testing a shorter treatment method for prostate cancer using proton therapy (PT), which is very precise and may cause fewer side effects compared to traditional radiation. However, it is expensive and not easily accessible for many patients. To make it more affordable and accessible, this study is testing whether 2 fractions of stereotactic body proton therapy (SBPT) can be as safe and effective as the standard 5 sessions.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Men aged < 18 years with histologically confirmed low- or intermediate-risk prostate cancer per NCCN guidelines
Eastern Cooperative Oncology Group (ECOG) performance status <2
Ability to undergo magnetic resonance imaging (MRI) simulation scans without absolute contraindications, such as cardiac implantable electronic devices
Ability to complete the Expanded Prostate Cancer Index Composite (EPIC) questionnaire
Disqualifiers
History of inflammatory bowel disease or other cancers (except prostate cancer)
Prior pelvic radiotherapy, chemotherapy, radical prostatectomy, cryosurgery, or focal therapy (e.g. high-intensity focused ultrasound [HIFU]) for prostate cancer
History of bladder neck or urethral stricture
Transurethral resection of the prostate (TURP) < 8 weeks prior to SBPT
Trial design
Design model
Single group
Treatments tested in this trial
Pencil Beam Proton Therapy Treatment Machine
Radiation2 fractions will be delivered to treat low- or intermediate- risk prostate cancer
Treatment groups
35 Participants
are divided into 1 treatment groupGroup A: 2-fraction Proton therapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Clinician-reported grade 2 or above genitourinary and gastrointestinal toxicity
Genitourinary and gastrointestinal toxicity were evaluated based on the Common Terminology Criteria for Adverse Events (CTCAE, version 5.0) developed by the National Cancer Institute (NCI). Adverse effects within 3 months post-treatment are classified as acute toxicities, while those occurring after 3 months are considered late toxicities.
Time frame
3 months and 24 months after treatment completion with a minimum of 24 months of follow-up and an average of 5 years.Secondary outcomes
1
Change in patient reported gastrointestinal and genitourinary symptoms
Gastrointestinal and genitourinary health-related quality of life (HQOL) are measured using the Expanded Prostate Cancer Index Composite (EPIC) questionnaire, which is a validated comprehensive instrument to measure the health-related quality of life among men with prostate cancer. EPIC consists of 5 primary domains, including urinary function, bowel habits, sexual function, hormonal functions, and overall satisfaction. Responses to each question form a Likert scale and are transformed to a 0-100 scale for each domain and subdomain, higher scores representing better HQOL.
Time frame
before treatment to 3-months and 24-months after treatment completed2
Biochemical Progression Free Survival (bPFS)
Biochemical progression-free survival (bPFS) among participants will be assessed during clinical follow-up. bPFS is defined as the duration of time a localized prostate cancer patient remains free from biochemical recurrence after treatment. Biochemical recurrence is defined as a prostate-specific antigen (PSA) increase of 2 ng/mL above the nadir based on the Phoenix criteria (nadir + 2 ng/mL), confirmed by a second PSA value obtained three or more weeks later.
Time frame
Treatment completion date to 5 years follow-up3
Distant Metastasis Free Survival
Distant metastasis (DM) refers to the spread of cancer cells from the prostate to distant sites outside the pelvic region. DF will be assessed during clinical follow-up using prostate-specific membrane antigen positron emission tomography (PSMA-PET), MRI, and/or other clinical imaging in cases of persistent PSA progression or emergence of symptoms. Distant metastasis free survival is defined as the duration of time from treatment completion date to the date of distant metastasis diagnosis by clinical imaging or death.
Time frame
Treatment completion date to 5 years follow-up4
Local Failure-Free Survival (LFFS)
Local Failure (LF) refers to recurrent prostatic mass diagnosed by digital rectal examination, clinical imaging techniques like PSMA-PET and/or MRI, or histopathological confirmation of recurrence by biopsy. Local failure-free survival is defined as the duration of time from treatment completion date to date of local failure diagnosis or death.
Time frame
Treatment completion date to 5 years follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov