Study to compare Internal Radiation boost and Concentrated High Dose External Radiotherapy Boost following Completion of External Beam Radiotherapy in Prostate Cancer

Comparative study on Brachytherapy Boost Vs. Stereotactic Body Radiotherapy (SBRT) Boost Following External Beam Radiotherapy (EBRT) in Intermediate and High Risk Prostate Cancer - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/03/063480

Enrollment

Registered

2024-03-04

Start date

Unknown

Completion date

Unknown

Last updated

2024-04-01

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: Stereotactic body radiation therapy (SBRT) Boost: Patient will be provided Radiotherapy boost in the form of Stereotactic body radiation therapy (SBRT) 21 Gy in 3 Fractions following t

Eligibility

Inclusion criteria

Inclusion criteria: a. Age: >18 years. b. Biopsy proven Adenocarcinoma of Prostate c. PSA more than 10 ng/ml d. Gleason score more than or equal to 7 e. Pelvic Lymph node positive f. No distant metastases g. Written and informed consent h. Informed consent. i. ECOG PS 0-2

Exclusion criteria

Exclusion criteria: a. Previous pelvic irradiation b. Radical prostatectomy c. Active medical implants like pacemaker d. Another active malignancy e. Uncontrolled co-morbid conditions e.g. uncontrolled hypertension, uncontrolled diabetes mellitus, coronary artery disease, uncontrolled COPD f. Deranged LFT, KFT

Design outcomes

Primary

Measure	Time frame
•To compare and evaluate the acute and well as the late toxicities in patients receiving single as well as multi fraction brachyboost. •To compare quality of life differences between the study groups using EPIC and IPSS scores. Timepoint: Acute toxicities: During Radiotherapy and 1 month following treatment Late Toxity: 3 months following which follow up 6 monthly Quality of life: 1 month following treatment then follow up at 3 months then every 6 monthly	—

Measure

Time frame

•To compare and evaluate the acute and well as the late toxicities in patients receiving single as well as multi fraction brachyboost. •To compare quality of life differences between the study groups using EPIC and IPSS scores. Timepoint: Acute toxicities: During Radiotherapy and 1 month following treatment Late Toxity: 3 months following which follow up 6 monthly Quality of life: 1 month following treatment then follow up at 3 months then every 6 monthly

—

Secondary

Measure	Time frame
• To find out Biochemical Disease free survival interval between the two armsTimepoint: TILL 2 YEARS	—

Countries

India

Contacts

Public ContactDr Haresh KP

All India Institute of Medical Sciences

drkpharesh@gmail.com9868332019

Outcome results

None listed

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