Prostate CancerNCT03873090
SBRT in 4 Fractions for Prostate Cancer
A study testing SBRT in people with Prostate Cancer, run by Istituto Clinico Humanitas.
Trial summary
This is a prospective multicentric phase-I-II pilot feasibility study. The main objective is to study early and late side effects of hypofractionated accelerated RT for prostate cancer with FFF (Free Flattened Filter) beam. The schedule will be [ 4 x 9.5 Gy = 38 Gy ] delivered in 5 alternative days. Read more about this study
- Who is it for?
- Ages 18 to 85 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- SBRT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- No sites listed yet
- Study dates
- 12 Jun 2013to 23 May 2018
- 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 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≤ 85years.
- WHO performance status ≤ 2.
- PSA>10 and ≤ 20 ng/ml or Gleason Score 7 or T2a-T2c.
- Histologically proven prostate adenocarcinoma
- No pathologic lymph nodes on CT/ MRI scan.
- No distant metastases.
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- No previous prostate surgery other than TURP (at least 6 weeks interval before initiation of RT).
- No malignant tumours in the previous 5 years.
- IPSS 0-7.
- Combined HT according to risk factors.
- Informed consent.
Who cannot join
- Prostate size greater than 60cc.
- Previous TURP less than 6 weeks before radiotherapy.
- Previous prostate surgery other than TURP.
- Diabetes *.
- Use of anticoagulants drugs *.
- Chronic inflammatory bowel disease *.
- Previous pelvic irradiation.
- Inability to obtain written informed consent.
About this study
Official title: Phase I-II Study of High Dose SBRT in 4 Fractions for Intermediate Risk Prostate Cancer
This is a prospective multicentric phase-I-II pilot feasibility study. The main objective is to study early and late side effects of hypofractionated accelerated RT for prostate cancer with FFF (Free Flattened Filter) beam. The schedule will be [ 4 x 9.5 Gy = 38 Gy ] delivered in 5 alternative days.
- Conditions
- Prostate Cancer
- Being tested
- SBRT
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBRTOther
hypofractionated accelerated RT for prostate cancer with FFF (Free Flattened Filter) beam. The schedule will be [ 4 x 9.5 Gy = 38 Gy ] delivered in 5 alternative days, corresponding to an NTD2 between 95 and 119 Gy for an α/β estimate between 3 and 1.5 Gy.
| Study group | Role | What they receive |
|---|---|---|
| SBRT in 4 fraction | Experimental | Selected intermediate risk prostate cancer patients treated with 4 fraction SBRT Receives: Other: SBRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicity assessment of 4 fractions SBRT in selected intermediate risk prostate cancer patients.
Toxicity assessment: The presence and grading (CTAE v3/ EORTC-RTOG) of adverse events will be recorded.
Measured: up to 5 years
Tumour response to local radiation therapy by assessing freedom from biochemical failure.
Tumour response is evaluated on ASTRO DEFINITION of PSA relapse (+2 from Nadir of PSA).
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2019
- Study start12 Jun 2013
- Primary completion23 May 2018
- Study completion23 May 2018
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.
- More trials run by Istituto Clinico HumanitasThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michele Tedeschi, Istituto Clinico Humanitas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03873090
- Sponsor's protocol ID
- 1136
- Status last verified
- Mar 2019
- First submitted
- 14 Feb 2019
- Last updated
- 13 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I-II Study of High Dose SBRT in 4 Fractions for Intermediate Risk Prostate Cancer
- ClinicalTrials.gov ID
- NCT03873090
- Acronym / sponsor ID
- 1136
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- 12 Jun 2013 (actual)
- Primary completion
- 23 May 2018 (actual)
- Study completion
- 23 May 2018 (actual)
- First posted
- 13 Mar 2019 (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.
This is a prospective multicentric phase-I-II pilot feasibility study. The main objective is to study early and late side effects of hypofractionated accelerated RT for prostate cancer with FFF (Free Flattened Filter) beam. The schedule will be [ 4 x 9.5 Gy = 38 Gy ] delivered in 5 alternative days.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SBRT in 4 fraction | Experimental | Other: SBRTSelected intermediate risk prostate cancer patients treated with 4 fraction SBRT |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≤ 85years.
- WHO performance status ≤ 2.
- PSA>10 and ≤ 20 ng/ml or Gleason Score 7 or T2a-T2c.
- Histologically proven prostate adenocarcinoma
- No pathologic lymph nodes on CT/ MRI scan.
Key exclusion criteria (8 listed)
- Prostate size greater than 60cc.
- Previous TURP less than 6 weeks before radiotherapy.
- Previous prostate surgery other than TURP.
- Diabetes *.
- Use of anticoagulants drugs *.
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 |
|---|---|---|
| SBRThypofractionated accelerated RT for prostate cancer with FFF (Free Flattened Filter) beam. The schedule will be [ 4 x 9.5 Gy = 38 Gy ] delivered in 5 alternative days, corresponding to an NTD2 between 95 and 119 Gy for an α/β estimate between 3 and 1.5 Gy. | Other | SBRT in 4 fraction |
Primary outcome
Toxicity assessment of 4 fractions SBRT in selected intermediate risk prostate cancer patients.
Time frame: up to 5 years
Toxicity assessment: The presence and grading (CTAE v3/ EORTC-RTOG) of adverse events will be recorded.
Tumour response to local radiation therapy by assessing freedom from biochemical failure.
Time frame: up to 5 years
Tumour response is evaluated on ASTRO DEFINITION of PSA relapse (+2 from Nadir of PSA).
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 13 Mar 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing SBRT in people with Prostate Cancer, run by Istituto Clinico Humanitas.
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 11 inclusion and 8 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 13 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Toxicity assessment of 4 fractions SBRT in selected intermediate risk prostate cancer patients. (time frame: up to 5 years). The study lists 2 primary outcomes in all. 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 13 Mar 2019.