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Short Course Radiotherapy for Localized Prostate Cancer

NCT03518853 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-12-22

No results posted yet for this study

Summary

Hypofractionated external beam radiotherapy has been clinically used for localized prostate cancer in view of the low estimated alpha/beta ratio of prostate cancer cells. Moderate fraction sizes of \<4Gy per fraction has been investigated in several phase II/III studies and has been found to be well tolerated with comparable biochemical control in comparison with standard fractionated dose-escalated regimens. Fraction sizes of \> 4 Gy has also been investigated in single center studies. However, its toxicity and disease control outcomes is less well known. In this Phase I/II single arm study the investigators aim to treat non-metastatic prostate cancer with stageT1-T4N0M0 and Prostate Specific Antigen (PSA) \<60 ng/ml to a regimen of 35Gy in 5 fractions delivered once a week with a view to determine acute toxicity, biochemical control with PSA and late toxicity.

Conditions

  • Adenocarcinoma of Prostate

Interventions

RADIATION

Short-course Hypofractionated Once-weekly Radiation Therapy

Eligible patients will be treated with a radiation regimen of 35 Gy in 5 fractions delivered at one fraction per week at 7 day intervals. The dose of radiotherapy is based on the consensus alpha beta ratio of 1.5.

Sponsors & Collaborators

  • Tata Medical Center

    lead OTHER

Principal Investigators

  • Indranil Mallick, MD · Tata Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2019-02-15
Completion
2019-02-15

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03518853 on ClinicalTrials.gov