Adenocarcinoma of ProstateSHORTNCT03518853
Short Course Radiotherapy for Localized Prostate Cancer
A study testing Short-course Hypofractionated Once-weekly Radiation Therapy in people with Adenocarcinoma of Prostate, run by Tata Medical Center at 1 site in India.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Adenocarcinoma of Prostate
- What is being tested?
- Short-course Hypofractionated Once-weekly Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIndia
- Study dates
- Dec 2013to 15 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I/II Study of Short-course Hypofractionated Once-weekly Radiation Therapy (SHORT) for Localized Prostate Cancer
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.
Read the 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.
- Conditions
- Adenocarcinoma of Prostate
- Being tested
- Short-course Hypofractionated Once-weekly Radiation Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short-course Hypofractionated Once-weekly Radiation TherapyRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| Short-course Radiation Therapy | Experimental | Short-course Hypofractionated Once-weekly Radiation Therapy: 35Gy in 5 fractions delivered once a week. Receives: Radiation: Short-course Hypofractionated Once-weekly Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 29
Secondary outcomes (5)
Biochemical control (with measurement of Prostate Specific Antigen measured in ng/ml)
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.
Measured: 3 years
Incidence of Late Gastrointestinal Toxicity as assessed by NCI CTCAE v4.0
the incidence of late gastrointestinal toxicity according to NCI CTCAE v4.0 as assessed at 3 years.
Measured: 3 years
Incidence of Late Genitourinary Toxicity as assessed by NCI CTCAE v4.0
To determine the incidence of late genitourinary toxicity according to NCI CTCAE v4.0 as assessed at 3 years.
Measured: 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
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.
Measured: 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
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2018
- Study startDec 2013
- Primary completion15 Feb 2019
- Study completion15 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenocarcinoma of ProstateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Phase I/II study of radiotherapy fractionation
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tata Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Indranil Mallick, MD, Principal investigator, Tata Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03518853
- Sponsor's protocol ID
- EC/TMC/0612
- Other IDs
- CTRI/2016/02/006671
- Acronym
- SHORT
- Status last verified
- Dec 2023
- First submitted
- 11 May 2016
- Last updated
- 22 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: Once appropriate authorities approach and once clearance of local authorities is received, data could be shared
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study of Short-course Hypofractionated Once-weekly Radiation Therapy (SHORT) for Localized Prostate Cancer
- ClinicalTrials.gov ID
- NCT03518853
- Acronym / sponsor ID
- SHORT / EC/TMC/0612
- Conditions
- Adenocarcinoma of Prostate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Tata Medical CenterUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- 15 Feb 2019 (actual)
- Study completion
- 15 Feb 2019 (actual)
- First posted
- 8 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Phase I/II study of radiotherapy fractionation
| Arm | Type | Receives |
|---|---|---|
| Short-course Radiation Therapy | Experimental | Radiation: Short-course Hypofractionated Once-weekly Radiation TherapyShort-course Hypofractionated Once-weekly Radiation Therapy: 35Gy in 5 fractions delivered once a week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Short-course Hypofractionated Once-weekly Radiation TherapyEligible 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. | Radiation | Short-course Radiation Therapy |
Primary outcome
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.
5 secondary outcomes
Biochemical control (with measurement of Prostate Specific Antigen measured in ng/ml)
Time frame: 3 years
Incidence of Late Gastrointestinal Toxicity as assessed by NCI CTCAE v4.0
Time frame: 3 years
Incidence of Late Genitourinary Toxicity as assessed by NCI CTCAE v4.0
Time frame: 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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2023.
- Individual participant dataSharing planned: Undecided. Once appropriate authorities approach and once clearance of local authorities is received, data could be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Indranil Mallick, MD principal investigator
Tata Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Short-course Hypofractionated Once-weekly Radiation Therapy in people with Adenocarcinoma of Prostate, run by Tata Medical Center at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2023.