Prostate Cancer
Conditions
Interventions
definitive radiation therapy using simultaneous integrated boost
Sponsors
Murofushi Keiko
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Patients receiving definitive radiotherapy for prostate cancer, regardless of the use of SpaceOAR. Diagnosis: Histologically confirmed diagnosis of prostate cancer. Lymph Node Involvement: Presence of pelvic lymph node metastasis confirmed by CT or MRI. Pelvic lymph nodes are defined as those in the internal iliac, external iliac, obturator, or presacral regions. Distant Metastases: No evidence of extrapelvic lymph node metastasis or visceral metastasis as confirmed by CT, PET/CT, or whole-body MRI. Bone Metastases: No evidence of bone metastasis based on either bone scintigraphy or whole-body MRI. Hormonal Therapy: Ongoing androgen deprivation therapy (ADT) for >=6 months at the time of radiotherapy initiation. - Exceptions: Patients diagnosed with castration-resistant prostate cancer or deemed unsuitable for hormonal therapy by the attending urologist may be included even if the duration of ADT is <6 months or if ADT has not been administered. - Radiotherapy initiation within 12 months of ADT initiation is recommended, but patients exceeding this period are still eligible. Performance Status: ECOG performance status of 0 or 1. Informed Consent: Written informed consent must be obtained from the patient prior to enrollment, following adequate explanation of the study.
Exclusion criteria
Exclusion criteria: a) Prior surgery for prostate cancer b) History of pelvic radiotherapy c) Active concurrent malignancies d) Active collagen vascular disease e) Uncontrolled diabetes mellitus f) Considered unsuitable for participation at the discretion of the principal investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Re-planning Rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of late adverse events at 2 year after radiotherapy Incidence of acute adverse events 2-year biochemical recurrence rate | — |
Contacts
Public ContactShota Minakami
Tokyo Metropolitan Hospital Organization Tokyo Metropolitan Bokutoh Hospital
Outcome results
None listed