Prostate Cancer Patients Treated by Radiotherapy
Conditions
Keywords
Proton Therapy, Clinician reported outcome, patient reported outcome, low or intermediate risk prostate cancer
Brief summary
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.
Detailed description
Proton therapy is an advanced form of radiation that precisely targets tumors while minimizing damage to healthy tissues. However, its high cost has limited patient access. For prostate cancer, studies have already shown that ultra-short radiation courses (as few as 2-5 sessions) using conventional X-ray-based stereotactic body radiation therapy (SBRT) provide excellent results with manageable side effects. This study aims to investigate whether 2-fraction stereotactic body proton therapy (SBPT) with magnetic resonance imaging (MRI) guidance and real-time on-board tumor tracking can achieve similar safety and efficiency as the standard 5-fraction SBPT, with the added benefit of lower costs and greater convenience for patients.
Interventions
RADIATIONPencil Beam Proton Therapy Treatment Machine
2 fractions will be delivered to treat low- or intermediate- risk prostate cancer
Sponsors
Hong Kong Sanatorium & Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * Prostate volume \> 100cc on MRI * Unilateral or bilateral hip replacements * Nodal or distant metastases, as indicated by computed tomography (CT), MRI, or prostate-specific membrane antigen (PSMA) positron emission tomography (PET) scans * Previous androgen deprivation therapy (ADT) lasting more than 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinician-reported grade 2 or above genitourinary and gastrointestinal toxicity | 3 months and 24 months after treatment completion with a minimum of 24 months of follow-up and an average of 5 years. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in patient reported gastrointestinal and genitourinary symptoms | before treatment to 3-months and 24-months after treatment completed | 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. |
| Biochemical Progression Free Survival (bPFS) | Treatment completion date to 5 years follow-up | 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. |
| Distant Metastasis Free Survival | Treatment completion date to 5 years follow-up | 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. |
| Local Failure-Free Survival (LFFS) | Treatment completion date to 5 years follow-up | 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. |
| Regional Failure Free Survival (RFFS) | Treatment completion date to 5 years follow-up | Regional Failure (RF) refers to recurrent in the regional lymph nodes diagnosed by clinical imaging techniques like PSMA-PET and/or MRI. Regional failure-free survival is defined as the duration of time from treatment completion date to date of regional failure diagnosis or death. |
Countries
Hong Kong
Contacts
CONTACTOi Lei Wong, Ph.D.
Outcome results
None listed