Health Condition 1: C61- Malignant neoplasm of prostate
Conditions
Interventions
Intervention1: Standard Arm: Radiotherapy to prostate and pelvic nodes (66-68Gy and 50Gy in 25 fractions OR 60-62Gy and 44Gy in 20 fractions OR 36.25-40Gy and 25Gy in 5 fractions)
with ADT for 2 years
Sponsors
TATA MEMORIAL HOSPITAL
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with biopsy proven prostate adenocarcinoma, deemed suitable for curative-intent radiotherapy 2. Clinicoradiological stage T1T4N0M0 using PSMA-PETCT and MRI 3.High risk or very high risk (as per NCCN 2023)stage T3a OR Gleason Score 8 or 9 OR PSA more than 20 4.Patient fit and able to receive ADT for 2 years 5.Patient fit and able to receive ARTA for 6 months 6.ECOG performance status 0-2 7.Patient able and willing for informed consent and reliable for follow-up
Exclusion criteria
Exclusion criteria: 1.Primary Gleason pattern 5 (Gleason score 9 or 10) 2.Life expectancy deemed to be less than 2 years 3.Uncontrolled comorbidities such as diabetes or hypertension causing ineligibility to receive ARTA 4.Bulky primary disease with extensive infiltration into bladder rectum or pelvic muscle 5.Prior ADT more than 3 months before screening or prior orchiectomy 6. Prior prostatectomy 7. Unsuitable for curative dose of radiotherapy (severe urinary obstructive symptoms, inflammatory bowel disease, prior pelvic radiotherapy etc.) 8.Presence of adverse pathological variants (such as small cell histology) 9.Unable or unwilling to consent and follow up
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-free survival (DFS), defined as the time to first clinicoradiological recurrence or death due to any cause, from the date of randomisation.Timepoint: 5 years | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. 5-year biochemical failure free survival (BFFS), metastasis free survival (MFS), overall survival (OS), prostate cancer specific survival (PCSS) 2. Testosterone kinetics and time to testosterone recovery 3. Acute and late radiotherapy related adverse effects 4. Acute and late ADT/ARTA related adverse effects 5. Patient-reported quality of life Timepoint: At 3-6 weeks from end of radiotherapy, then 3-6 monthly for two years, 6-12 monthly thereafter Serum PSA and testosterone every 3-6 months for first two years and 6-12 monthly thereafter Toxicity scoring with CTCAE v5.0 at every follow up visit Patient-reported QOL at randomisation, and at 6, 12, 24, 36, 48, 60 months Imaging at biochemical failure or suspected clinical progression, modality as clinically indicated | — |
Countries
India
Contacts
Public ContactDr Vedang Murthy
Tata Memorial Hospital
Outcome results
None listed