Prostate CancerPhase 2NCT02313298
Stereotactic Body Radiotherapy for Organ Confined Prostate Cancer
A Phase 2 study testing Stereotactic Body Radiotherapy in people with Prostate Cancer, run by National Cancer Centre, Singapore at 1 site in Singapore.
Trial summary
A single arm phase II study of SBRT for prostate cancer to primarily assess acute and late toxicity and secondarily PSA outcomes and quality of life measurements of an extreme hypofractionated regimen of 36.25Gy in 5 fractions over 10-11 days. Read more about this study
- Who is it for?
- Ages 21 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Stereotactic Body Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSingapore
- Study dates
- Jun 2013to Dec 2021
- Phase
- Phase 2
- 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 21 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed diagnosis of adenocarcinoma of the prostate
- History/physical examination with digital rectal examination of the prostate within 60 days prior to registration
- Histological evaluation of prostate biopsy with assignment of a Gleason score to the biopsy material; Gleason scores 2-7
- Clinical stage T1-2b (DRE) (AJCC 7th edition) within 90 days of registration
- PSA < 20 ng/mL within 60 days prior to registration. PSA should not be obtained within 10 days after prostate biopsy. (Every effort should be made to obtain all serum PSA values obtained in the 1 year prior to treatment to allow for calculation of PSA kinetics.)
- Not more than one intermediate risk factor (T2b/GS7/PSA 10-20)
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- Zubrod Performance Status 0-1 within 60 days prior to registration
- Age ≥ 21
- Patient must be able to provide study-specific informed consent prior to study entry.
- Willingness and ability to complete the Expanded Prostate Cancer Index Composite (EPIC) questionnaire
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. (For example, carcinoma of the oral cavity is permissible; however, patients with prior history of bladder cancer are not allowed)
- T-stage ≥ T2c on staging MRI
- Evidence of distant metastases
- Regional lymph node involvement
- Previous radical surgery (prostatectomy), cryosurgery, or HIFU for prostate cancer
- Previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy
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- Previous hormonal therapy, such as LHRH agonists (e.g., goserelin, leuprolide) or LHRH antagonists (e.g., degarelix), anti-androgens (e.g., flutamide, bicalutamide), estrogens (e.g., DES), or surgical castration (orchiectomy)
- Use of finasteride within 30 days prior to registration. PSA should not be obtained prior to 30 days after stopping finasteride.
- Use of dutasteride within 90 days prior to registration. PSA should not be obtained prior to 90 days after stopping dutasteride.
- Previous or concurrent cytotoxic chemotherapy for prostate cancer
- Severe, active co-morbidity, 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.)
- Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immuno-compromised patients.
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
National Cancer Centre Singapore
Singapore, 169610
About this study
Official title: A Phase II Trial of Prostate Stereotactic Radiotherapy
A single arm phase II study of SBRT for prostate cancer to primarily assess acute and late toxicity and secondarily PSA outcomes and quality of life measurements of an extreme hypofractionated regimen of 36.25Gy in 5 fractions over 10-11 days.
Read the detailed description
This is a single arm phase II study of SBRT for prostate cancer to primarily assess acute and late toxicity and secondarily PSA outcomes and quality of life measurements of an extreme hypofractionated regimen of 36.25Gy in 5 fractions over 10-11 days. The radiation therapy is to be delivered using intensity modulated radiotherapy (IMRT) with the aid of volumetric image guidance to ensure accuracy. Toxicity will be measured at preset intervals, as will HRQOL parameters using the Expanded Prostate Index Composite (EPIC) questionaire which focuses on bowel, urinary, sexual and hormonal symptoms.
- Conditions
- Prostate Cancer
- Being tested
- Stereotactic Body Radiotherapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Body RadiotherapyRadiation
IMRT or similar techniques that use inverse treatment planning
| Study group | Role | What they receive |
|---|---|---|
| Stereotactic Body Radiotherapy | Experimental | An extreme hypofractionated regimen of 36.25Gy in 5 fractions over 10-11 days Receives: Radiation: Stereotactic Body Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of late severe GI and GU toxicities
Measured: 2 years
Secondary outcomes (10)
The rate of late severe GI and GU toxicities
Measured: 1 and 5 years
The rate of acute severe GI and GU toxicities
Measured: 1, 2 and 5 years
PSA failure-free survival
Measured: 1, 2 and 5 years
Disease-free survival (DFS)
Measured: 1, 2 and 5 years
Time to local progression
Measured: 1, 2 and 5 years
Time to distant and/or regional failure
Measured: 1, 2 and 5 years
Disease-specific survival
Measured: 1, 2 and 5 years
Freedom from biochemical recurrence (FFBR)
Measured: 1, 2 and 5 years
Overall survival (OS)
Measured: 1, 2 and 5 years
The change in quality of life outcomes from baseline
Measured: 1, 2 and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2014 (estimated)
- Study startJun 2013
- Primary completionDec 2018 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Centre, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Melvin LK Chua, Study director, National Cancer Centre, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02313298
- Sponsor's protocol ID
- NCCS DRO SBRT
- Status last verified
- Mar 2018
- First submitted
- 7 Dec 2014
- Last updated
- 29 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Prostate Stereotactic Radiotherapy
- ClinicalTrials.gov ID
- NCT02313298
- Acronym / sponsor ID
- NCCS DRO SBRT
- Conditions
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- National Cancer Centre, SingaporeUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 10 Dec 2014 (estimated)
- 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.
A single arm phase II study of SBRT for prostate cancer to primarily assess acute and late toxicity and secondarily PSA outcomes and quality of life measurements of an extreme hypofractionated regimen of 36.25Gy in 5 fractions over 10-11 days.
Detailed description
This is a single arm phase II study of SBRT for prostate cancer to primarily assess acute and late toxicity and secondarily PSA outcomes and quality of life measurements of an extreme hypofractionated regimen of 36.25Gy in 5 fractions over 10-11 days. The radiation therapy is to be delivered using intensity modulated radiotherapy (IMRT) with the aid of volumetric image guidance to ensure accuracy. Toxicity will be measured at preset intervals, as will HRQOL parameters using the Expanded Prostate Index Composite (EPIC) questionaire which focuses on bowel, urinary, sexual and hormonal symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stereotactic Body Radiotherapy | Experimental | Radiation: Stereotactic Body RadiotherapyAn extreme hypofractionated regimen of 36.25Gy in 5 fractions over 10-11 days |
Who may qualify
- Ages
- 21 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically confirmed diagnosis of adenocarcinoma of the prostate
- History/physical examination with digital rectal examination of the prostate within 60 days prior to registration
- Histological evaluation of prostate biopsy with assignment of a Gleason score to the biopsy material; Gleason scores 2-7
- Clinical stage T1-2b (DRE) (AJCC 7th edition) within 90 days of registration
- PSA < 20 ng/mL within 60 days prior to registration. PSA should not be obtained within 10 days after prostate biopsy. (Every effort should be made to obtain all serum PSA values obtained in the 1 year prior to treatment to allow for calculation of PSA kinetics.)
Key exclusion criteria (17 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. (For example, carcinoma of the oral cavity is permissible; however, patients with prior history of bladder cancer are not allowed)
- T-stage ≥ T2c on staging MRI
- Evidence of distant metastases
- Regional lymph node involvement
- Previous radical surgery (prostatectomy), cryosurgery, or HIFU 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 |
|---|---|---|
| Stereotactic Body RadiotherapyIMRT or similar techniques that use inverse treatment planning | Radiation | Stereotactic Body Radiotherapy |
Primary outcome
The rate of late severe GI and GU toxicities
Time frame: 2 years
10 secondary outcomes
The rate of late severe GI and GU toxicities
Time frame: 1 and 5 years
The rate of acute severe GI and GU toxicities
Time frame: 1, 2 and 5 years
PSA failure-free survival
Time frame: 1, 2 and 5 years
Disease-free survival (DFS)
Time frame: 1, 2 and 5 years
Time to local progression
Time frame: 1, 2 and 5 years
Time to distant and/or regional failure
Time frame: 1, 2 and 5 years
Disease-specific survival
Time frame: 1, 2 and 5 years
Freedom from biochemical recurrence (FFBR)
Time frame: 1, 2 and 5 years
Overall survival (OS)
Time frame: 1, 2 and 5 years
The change in quality of life outcomes from baseline
Time frame: 1, 2 and 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2018.
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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.
Melvin LK Chua study director
National Cancer Centre, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Stereotactic Body Radiotherapy in people with Prostate Cancer, run by National Cancer Centre, Singapore at 1 site in Singapore.
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 10 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 29 Mar 2018. 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 Singapore. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jonathan YH Teh (63214204, jonathan.Teh.Y.H@nccs.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of late severe GI and GU toxicities (time frame: 2 years). 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 29 Mar 2018.