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Study to assess the change in urinary symptoms in patients with moderate to high risk prostate cancer treated with shorter duration radiotherapy with higher dose to the tumour area

Observational Study Assessing Change in Symptom Scoring in Patients with Intermediate to High Risk Prostatic Cancer Receiving Hypofractionated Radiotherapy (HFRT) with Intraprostatic Dose Escalation - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2026/04/109233
Enrollment
15
Registered
2026-04-23
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-27

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: Nil: Nil Intervention2: Nil: Nil

Sponsors

Novesh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients with histologically confirmed prostate cancer classified as intermediate to high risk who are scheduled to receive hypofractionated radiotherapy with intraprostatic dose escalation will be included in the study. Eligible participants must be 18 years or older, willing to provide informed consent, and capable of completing symptom scoring questionnaires, specifically the International Prostate Symptom Score (IPSS) and the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ).

Exclusion criteria

Exclusion criteria: Patients who received prior pelvic radiotherapy, have metastatic disease at presentation, suffer from severe uncontrolled comorbid illnesses, or are unable to complete follow-up or questionnaires will be excluded.

Design outcomes

Primary

MeasureTime frame
Mean change in International Prostate Symptom Score (IPSS) from baselineTimepoint: Baseline, at completion of radiotherapy and 3 months post-treatment—

Secondary

MeasureTime frame
Incidence and severity of acute genitourinary and gastrointestinal radiation toxicity assessed using CTCAE version 5.0Timepoint: During radiotherapy and up to 3 months post-treatment;Change in quality of life scores assessed using EORTC QLQ-C30 and EORTC QLQ-PR25 questionnaires.Timepoint: Baseline, at completion of radiotherapy, 3 months post-treatment;Change in serum prostate-specific antigen (PSA) levels from baselineTimepoint: Baseline, 3 months—

Countries

India

Contacts

Public ContactNovesh

AIIMS Rishikesh

drdeepajoseph@yahoo.com8978386509

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026