- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03518853
Short Course Radiotherapy for Localized Prostate Cancer (SHORT)
Phase I/II Study of Short-course Hypofractionated Once-weekly Radiation Therapy (SHORT) for Localized Prostate Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
There is robust evidence to suggest that prostate cancers are slow growing with long tumor doubling times. Evidence accumulated from reported results of several thousands of patients suggest that unlike epithelial malignancies, the alpha/beta ratio for prostate cancer is low, in the range of 1.5 compared to 10. From the radiobiological standpoint, this means that instead of conventional daily fraction sizes of 1.8-2Gy, prostate cancer will be equally well if not better approached with larger fraction sizes. Based on this derivation several single arm and randomized studies have been started. Some have already been reported. They show quite uniformly that hypofractionated radiotherapy using fraction sizes of 2.6-3.1 Gy/fraction with appropriate modifications in the total dose is safe and effective. Therefore the paradigm of radiotherapy treatment of prostate cancer is shifting from 37-40Fractions delivered over 7-8 weeks to shorter courses delivered in 20-28fractions delivered over 4-5 weeks.
Taking this approach further it has been hypothesized that the schedule may be modified further and the total number of treatments can be reduced to 4-7 fractions delivered in a spaced schedule over 2-5 weeks. There are already 6-7 published reports of non-randomized cohorts treated with such schedules delivered using Image Guided Intensity modulated Radiation Therapy (IG-IMRT) or stereotactic radiotherapy (SBRT) techniques for localized risk cancers. Preliminary results from these studies show excellent safety and efficacy. These results have considerable implications. If the treatment of prostate cancer can be safely and effectively truncated from 37-40 fractions over 8 weeks to only 4-7 treatments delivered over 2-5 weeks, it results in better patient convenience, compliance, cost savings and also a significant sparing of healthcare resources. All of these are of great importance in countries like India.
The short course hypofractionated schedules have so far been mainly tried in selected risk groups, and have not previously been used in India. The investigators intend to perform a phase I/II study to test the safety and efficacy of a schedule of once weekly hypofractionated radiotherapy. The study population will be 30 patients with localized prostate cancer (T1-T4N0M0) with a PSA <60 ng/ml. The patients will receive image-guided radiotherapy (IGRT) delivering 5 fractions of 7Gy at weekly intervals. Androgen deprivation therapy will be done according to standard criteria based on risk stratification. The primary endpoint of this study is the incidence of acute grade 2 or more side-effects. The secondary endpoints will be biochemical control at 3 years and late grade 2 side-effects at 2 years. Side effects will be monitored according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4. Quality of life assessments will be done using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30 and PR25 questionnaires at baseline, treatment completion, 3 and 6 months post treatment.
If found safe and effective, this schedule of treatment will lead to phase I studies comparing this schedule with standard fractionation or more moderate hypofractionation schedules.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
WestBengal
-
Kolkata, WestBengal, India, 700156
- Tata Medical Centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Short-course Radiation Therapy
Short-course Hypofractionated Once-weekly Radiation Therapy: 35Gy in 5 fractions delivered once a week.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Acute Gastrointestinal and Genitourinary toxicity as assessed by National Cancer Institute(NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Time Frame: Day 29
|
To determine the rates of acute gastrointestinal and genitourinary toxicity according to NCI CTCAE v4.0.
|
Day 29
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Biochemical control (with measurement of Prostate Specific Antigen measured in ng/ml)
Time Frame: 3 years
|
To determine the incidence of biochemical control (with measurement of prostate specific antigen) at 3 years.
Failure is defined by the Phoenix criteria of nadir PA value in ng/ml + 2 ng/ml.
|
3 years
|
Incidence of Late Gastrointestinal Toxicity as assessed by NCI CTCAE v4.0
Time Frame: 3 years
|
the incidence of late gastrointestinal toxicity according to NCI CTCAE v4.0 as assessed at 3 years.
|
3 years
|
Incidence of Late Genitourinary Toxicity as assessed by NCI CTCAE v4.0
Time Frame: 3 years
|
To determine the incidence of late genitourinary toxicity according to NCI CTCAE v4.0 as assessed at 3 years.
|
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
Time Frame: 3 years
|
To evaluate the quality of life using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30 questionnaire and measure the impact of this regimen of radiotherapy on the global health status, functional scales and all general symptom scores on a scale of 0 to 100 (higher score in global and functional scales representing better quality-of-life, while higher sores on symptom scales representing more symptoms).
A scale difference of 10 or more would be considered clinically meaningful in any domain.
|
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
Time Frame: 3 years
|
To evaluate the quality of life using the PR25 questionnaire and measure the impact of this regimen of radiotherapy on the prostate cancer related urinary, bowel and hormonal therapy related scores on a scale of 0 to 100 (higher score on symptom scales representing more symptoms).
A scale difference of 10 or more would be considered clinically meaningful in any domain.
|
3 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Indranil Mallick, MD, Tata Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EC/TMC/0612
- CTRI/2016/02/006671 (Registry Identifier: Clinical Trials Registry of India (CTRI))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Adenocarcinoma of Prostate
-
Case Comprehensive Cancer CenterTerminatedAdenocarcinoma of Prostate | Adenocarcinoma of the Prostate Stage I | Adenocarcinoma of the Prostate Stage II | Adenocarcinoma of the Prostate Stage IIIUnited States
-
Dana-Farber Cancer InstituteCompletedProstate Cancer | Adenocarcinoma of the Prostate Stage I | Adenocarcinoma of the Prostate Stage II | Adenocarcinoma of the Prostate Stage IIIUnited States
-
Bagcilar Training and Research HospitalCompletedAdenocarcinoma of ProstateTurkey
-
UNICANCERFerring PharmaceuticalsActive, not recruitingAdenocarcinoma of ProstateFrance
-
Centre Georges Francois LeclercActive, not recruiting
-
University Hospital, BrestRecruitingAdenocarcinoma of the ProstateFrance
-
Sidney Kimmel Comprehensive Cancer Center at Johns...CompletedProstate Cancer | Adenocarcinoma of the ProstateUnited States
-
Centre Hospitalier Universitaire de NīmesActive, not recruitingAdenocarcinoma of the ProstateFrance
-
Sidney Kimmel Comprehensive Cancer Center at Johns...CompletedAdenocarcinoma of the ProstateUnited States
-
James TaylorCompleted
Clinical Trials on Short-course Hypofractionated Once-weekly Radiation Therapy
-
University of RochesterTerminatedCancer, RectalUnited States
-
Jong Hoon LeeNational Cancer Center, Korea; Samsung Medical Center; Seoul National University...UnknownRectal CancerKorea, Republic of
-
Weill Medical College of Cornell UniversityNational Cancer Institute (NCI)Recruiting
-
Medical University of ViennaRecruiting
-
University of UtahNational Cancer Institute (NCI)RecruitingCervical Carcinoma | Endometrial CarcinomaUnited States
-
National Cancer Institute, EgyptCompletedLocally Advanced Rectal CarcinomaEgypt
-
Trans Tasman Radiation Oncology GroupAustralasian Gastro-Intestinal Trials Group; Colorectal Surgical Society of... and other collaboratorsCompletedAdenocarcinoma of RectumAustralia, New Zealand
-
Changhai HospitalRecruitingLocalized Prostate CancerChina
-
University of UtahActive, not recruitingStage 0 Breast Cancer | Stage I Breast Cancer | Stage II Breast Cancer | Invasive Breast Carcinoma | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Ductal Breast Carcinoma In SituUnited States
-
Mayo ClinicNational Cancer Institute (NCI)Active, not recruitingAnatomic Stage I Breast Cancer AJCC v8 | Anatomic Stage IA Breast Cancer AJCC v8 | Anatomic Stage IB Breast Cancer AJCC v8 | Anatomic Stage IIA Breast Cancer AJCC v8 | Prognostic Stage I Breast Cancer AJCC v8 | Prognostic Stage IA Breast Cancer AJCC v8 | Prognostic Stage IB Breast Cancer AJCC v8 | Prognostic Stage IIA Breast Cancer AJCC...United States