Men diagnosed with low- to favorable intermediate-risk localized prostate cancer Prostate cancer, SBRT, DIL, MR Linac, ultrahypofraction
Conditions
Interventions
SBRT 26 Gy/2 fractions with 32 Gy SIB to DIL. The MR-defined DIL was the gross tumor volume (GTV), and the whole prostate gland and seminal vesicles were the clinical target volume (CTV). The planning
SBRT 26 Gy/2 fractions with 32 Gy SIB to DIL,SBRT 36.25Gy/5 fractions with 40 Gy SIB to DIL
Sponsors
Division of Radiation Oncology, Department of Radiology, Faculty of Medicine, Siriraj Hospital
THE FOUNDATION FOR CANCER CARE SIRIRAJ HOSPITAL
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Men 18 years old or more 2. Newly diagnosed and histologically confirmed localized prostate adenocarcinoma 3. Very low-, low- and favorable intermediate-risk via NCCN risk group classification, defined as Gleason grade group 1 or 2 Clinical stage T1-T2c Initial PSA < 20 ng/ml (Patient can have only one of cT2b-cT2c, Gleason grade group 2 and PSA 10-20 ng/ml) 4. Visible dominant-intraprostatic lesion (DIL) on multi-parametric MRI defined by PI-RADS classification 5. ECOG Performance Status 0-2 within 28 days prior to study entry 6. Patients must be able to provide study-specific informed consent prior to study entry.
Exclusion criteria
Exclusion criteria: 1. Direct extraprostatic extension into the adjacent structures 2. Extraprostatic metastases or malignant nodes 3. Large prostate volume > 90 cm3 by imaging 4. Use of Androgen deprivation therapy 5. Baseline IPSS > 13 6. MRI-contraindicated patient (eg. MRI-incompatible pacemaker, metal implant) 7. Patient with hip prosthesis which cause artifact on MR images 8. Patient with significant predisposing comorbidity (eg. inflammatory bowel disease) 9. Prior radiotherapy to the region of the pelvis that would result in excessive doses to normal tissues due to overlap of radiation therapy fields 10. Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years (Note that carcinoma in situ of the breast, oral cavity, or cervix are all permissible)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Acute genitourinary toxicity (GU) at 3 months after end of the intervention CTCAE V5.0 | — |
Secondary
| Measure | Time frame |
|---|---|
| Acute gastrointestinal toxicity (GI) at 3 months after end of the intervention CTCAE V5.0,Late genitourinary toxicity (GU) 6 months to 2 years CTCAE V5.0,Late gastrointestinal toxicity (GI) 6 months to 2 years CTCAE V5.0,Biochemical failure-free survival 6 months to 5 years PSA (ng/ml),Local recurrence-free survival 6 months to 5 years Imaging (MRI),CD4 CD8+ and CD16/56+ lymphocyte count After start radiation 8-days, 1-, 2-, 3-, 6-, 9- and 12-months - | — |
Countries
Thailand
Contacts
Public ContactRatchapas Romrattaphan
Faculty of Medicine, Siriraj Hospital, Mahidol University
Outcome results
None listed