EARLY TOXICITIES AND CLINICAL OUTCOMES OF EXTENDED FIELD RADIATION THERAPY IN PROSTATE CANCER
- Conditions
- Health Condition 1: C61- Malignant neoplasm of prostate
- Registration Number
- CTRI/2021/10/037060
- Lead Sponsor
- PGIMER
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1. HISTO-PATHOLOGICALLY PROVEN CASES OF ADENOCARCINOMA PROSTATE.
2. PATIENTS FULFILLING EITHER OF THE FOLLOWING CRITERIA:
A) CLINICALLY PELVIC LYMPH NODE POSITIVE NON-METASTATIC DISEASE.
B) STAGE M1A (PARA-AORTIC NODES/COMMON ILIAC NODAL INVOLVEMENT).
C) PATHOLOGICAL NODE POSITIVITY AFTER RADICAL PROSTATECTOMY.
D) POST OP CASES WITH RADIOLOGICALLY POSITIVE LYMPH NODES, TO BE PLANNED FOR SALVAGE RADIOTHERAPY.
E) HIGH-RISK DISEASE WITH RISK OF LYMPH NODE INVOLVEMENT >15% BY ROACH FORMULA.
(2/3 X PROSTATE-SPECIFIC ANTIGEN +(GLEASON SCORE-6) x10).
3. PATIENTS WITH GOOD PERFORMANCE STATUS ECOG 0-2.
4. PATIENTS WHO GIVE SIGNED INFORMED CONSENT.
1. PROSTATE CANCER PATIENTS WITH ANY OF THE FOLLOWING.
A) BONE OR VISCERAL METASTATIC DISEASE.
B) POSITIVE NON-REGIONAL LYMPH NODES (CLINICAL/IMAGING/PATHOLOGY) OTHER THAN IN COMMON ILIAC OR PARA-AORTIC REGIONS.
C) HISTORY OF PRIOR RADIOTHERAPY TO PELVIS AND/OR PARA-AORTIC REGION.
2. PATIENTS WITH POOR PERFORMANCE STATUS ECOG-3/4.
3. PATIENTS WITH LIFE EXPECTANCY LESS THAN 2 YEARS.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method TO ASSESS EXTENDED FIELD RADIOTHERAPY WITH VOLUMETRIC ARC THERAPY IN PROSTATE CANCER PATIENTS WITH OR AT HIGH RISK OF AT HIGH RISK OF PARA- AORTIC NODAL METASTASES IN TERMS OF ACUTE ADVERSE EVENTS OF: <br/ ><br>A) GASTROINTESTINAL SYSTEM <br/ ><br>B) GENITOURINARY SYSTEM <br/ ><br>C) HEMATOLOGICAL SYSTEM <br/ ><br>Timepoint: A) BASELINE <br/ ><br>B) WEEKLY DURING RADIATION <br/ ><br>C) MONTHLY AFTER COMPLETION OF RADIATION UPTO 3 MONTHS
- Secondary Outcome Measures
Name Time Method 1. TO ASSESS THE QUALITY OF LIFE USING EORTC QLQ C30 AND PROSTATE CANCER MODULE. <br/ ><br>2. TO ASSESSE TREATMENT RESPONSE BY SERUM PSA AND GA68 PSMA PET/CT.Timepoint: QUALITY OF LIFE AT BASELINE, COMPLETION OF TREATMENT AND 3 MONTHS. <br/ ><br>TREATMENT RESPONSE AT 3 MONTHS AFTER COMPLETION OF RADIATION THERAPY.