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EARLY TOXICITIES AND CLINICAL OUTCOMES OF EXTENDED FIELD RADIATION THERAPY IN PROSTATE CANCER

EARLY TOXICITIES AND CLINICAL OUTCOMES OF EXTENDED FIELD RADIATION THERAPY WITH VOLUMETRIC MODULATED ARC THERAPY IN PROSTATE CANCER

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/10/037060
Enrollment
10
Registered
2021-10-04
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C61- Malignant neoplasm of prostate

Interventions

Intervention1: RADIOTHERAPY: EXTENDED FIELD PELVIC RADIOTHERAPY WITH VOLUMETRIC MODULATED ARC THERAPY. RADICAL 60 Gy FOR 20 FRACTIONS OVER 4 WEEKS EVERY MONDAY TO FRIDAY WITH SIMULTANEOUS INTEGRATED B

Sponsors

PGIMER
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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: A) GASTROINTESTINAL SYSTEM B) GENITOURINARY SYSTEM C) HEMATOLOGICAL SYSTEM Timepoint: A) BASELINE B) WEEKLY DURING RADIATION C) MONTHLY AFTER COMPLETION OF RADIATION UPTO 3 MONTHS—

Secondary

MeasureTime frame
1. TO ASSESS THE QUALITY OF LIFE USING EORTC QLQ C30 AND PROSTATE CANCER MODULE. 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. TREATMENT RESPONSE AT 3 MONTHS AFTER COMPLETION OF RADIATION THERAPY.—

Countries

India

Contacts

Public ContactDR DEEPAK SHARMA

PGIMER, CHANDIGARH

pkannan10011988@gmail.com9442395508

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026