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Empty bladder protocol in Prostate SBRT

Toxicity with empty bladder protocol during prostate stereotactic body radiotherapy (EMPTY-RT): A phase 2 study - EMPTY-RT

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/08/056231
Enrollment
100
Registered
2023-08-07
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-13

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 Control Intervention1: NIL: NIL

Sponsors

Tata Memorial Centre Department of Atomic Energy Clinical Trial Centre
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.  Histologically proven carcinoma prostate. 2.  Patients must have been planned for prostate SBRT for the treatment of their cancer 3.  Patients must be able to understand and sign the informed consent form for the study.

Exclusion criteria

Exclusion criteria: 1.Previous history of pelvic radiation. 2.Patients undergoing post-operative RT 3.Patients being planned for treatment with moderate hypofractionation. 4. Patients planned for ONLY nodal irradiation.

Design outcomes

Primary

MeasureTime frame
To assess the acute toxicity in patients undergoing SBRT with empty bladder & compare it with a similar cohort of patients undergoing RT with a full bladder in the ongoing PRIME trialTimepoint: Two years—

Secondary

MeasureTime frame
1 To assess bladder volume variability with empty bladder protocol. 2 To assess the feasibility of planning SBRT with the existing dose constraints using an empty bladder protocol. 3 To assess late toxicity in patients undergoing SBRT with empty bladder & compare it with a similar cohort of patients undergoing RT with a full bladder . 4 To assess and compare the patients perception of treatment with full bladder protocols undergoing SBRT Timepoint: Two Years—

Countries

India

Contacts

Public ContactDr. Simran Gulati

ACTREC, Tata Memorial Centre

vedangmurthy@gmail.com02224177028

Outcome results

None listed

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