Short Course Radiotherapy for Localized Prostate Cancer

NCT03518853 | Completed DMC

• 2 other identifiers: EC/TMC/0612CTRI/2016/02/006671
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Incidence of Acute Gastrointestinal and Genitourinary toxicity as assessed by National Cancer Institute(NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0

  To determine the rates of acute gastrointestinal and genitourinary toxicity according to NCI CTCAE v4.0.

  Day 29

Secondary Outcomes (5)

• Biochemical control (with measurement of Prostate Specific Antigen measured in ng/ml)

  3 years

• Incidence of Late Gastrointestinal Toxicity as assessed by NCI CTCAE v4.0

  3 years

• Incidence of Late Genitourinary Toxicity as assessed by NCI CTCAE v4.0

  3 years

• Assessing the Quality of Life by measuring patient reported outcomes using European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30 questionnaire

  3 years

• Assessing the Quality of Life by measuring patient reported outcomes using European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) PR25 questionnaire

  3 years

Study Arms (1)

Short-course Radiation Therapy

EXPERIMENTAL

Short-course Hypofractionated Once-weekly Radiation Therapy: 35Gy in 5 fractions delivered once a week.

Radiation: Short-course Hypofractionated Once-weekly Radiation Therapy

Interventions

Short-course Hypofractionated Once-weekly Radiation Therapy RADIATION

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.

Short-course Radiation Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed prostate adenocarcinoma.
• History/physical examination with digital rectal examination of the prostate within 8 weeks prior to registration
• Histological evaluation of prostate biopsy with assignment of a Gleason score to the biopsy material.
• Clinical stage T1-T4N0M0 (AJCC 7th edition). Staging demands a multiparametric MRI of the pelvis a CT or MRI of the abdomen for T3/T4 tumors or PSA \>10 a whole body bone scan for T3/T4 tumors or PSA \>10
• PSA \< 60 ng/mL within 180 days prior to registration. PSA should not be obtained for at least 10 days after prostate biopsy.
• WHO performance status 0-1
• Age ≥ 18
• Patient must sign study specific informed consent prior to accrual.

You may not qualify if:

• Prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease free for a minimum of 5 years.
• Previous radical surgery (prostatectomy) or cryosurgery for prostate cancer
• Previous pelvic irradiation in any form.
• Previous hormonal therapy of more than 180 days duration prior to registration.
• Previous or concurrent cytotoxic chemotherapy for prostate cancer
• Severe, active comorbidity, defined as follows:
• Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
• Transmural myocardial infarction within the last 6 months
• Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
• Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
• Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol. (Patients on Coumadin or other blood thinning agents are eligible for this study.)
• Renal insufficiency with a creatinine clearance of \<30ml/min

Sponsors & Collaborators

• Tata Medical Center: lead

Study Sites (1)

Tata Medical Centre

Kolkata, WestBengal, 700156, India

Location

Study Officials

• Indranil Mallick, MD

  Tata Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Phase I/II study of radiotherapy fractionation

Study Record Dates

• First Submitted: May 11, 2016
• First Posted: May 8, 2018
• Study Start: December 1, 2013
• Primary Completion: February 15, 2019
• Study Completion: February 15, 2019
• Last Updated: December 22, 2023

Record last verified: 2023-12

Locations

IN (1)