Health Condition 1: C61- Malignant neoplasm of prostate
Conditions
Interventions
Intervention1: Standard
Arm: Radiotherapy to prostate and whole pelvis with standard systemic therapy
Control Intervention1: Test Arm: Radiotherapy to prostate and whole pelvis with standard systemic
Sponsors
Tata Memorial Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with biopsy proven prostate adenocarcinoma, deemed suitable for curative intent radiotherapy 2. Involvement of lymph nodes within pelvis (up to the aortic bifurcation) as per staging PSMA-PETCT at diagnosis 3. Involved node identifiable in the radiotherapy planning CT scan 4. Patient able and willing for informed consent and reliable for follow-up 5. ECOG performance status 0-2
Exclusion criteria
Exclusion criteria: 1. Prior prostatectomy or prostate radiotherapy 2. Prior androgen deprivation >6 months 3. Unsuitability for curative pelvic radiotherapy (severe urinary obstructive symptoms, inflammatory bowel disease, prior pelvic radiotherapy etc.) 4. Unsuitable for nodal boost due to anatomical or dosimetric considerations
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-free survival (DFS), defined as the time to first biochemical or radiological recurrence or death due to prostate cancer, from the date of randomisation.Timepoint: 5 years | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Metastasis-free survival (MFS); event defined as first occurrence of distant metastasis, or death due to any cause. 2. Overall survival (OS); event defined as death due to any cause. 3. Radiotherapy related urinary and GI toxicity by CTCAE v5.0, acute (within 90 days of radiotherapy completion) and late (after 90 days of radiotherapy completion) 4. Annual patient-reported PRO-CTCAE scores Timepoint: 5 years | — |
Countries
India
Contacts
Public ContactDrPriyamvada Maitre
Tata Memorial Hospital
Outcome results
None listed