Prostate CancerHRT20NCT03851926
Hypofractionated Radiotherapy for Prostate Cancer
An observational study of Prostate Cancer, run by Consorci Sanitari de Terrassa at 1 site in Spain.
Trial summary
Radiotherapy is a standard definitive treatment for men with localized prostate cancer. Recent improvements in technology allow high doses of radiation to be delivered to the prostate in less days with lower doses to surrounding healthy tissues, trying to reduce side effects. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Hypofractionated volumetric radiotherapy in 20 fractions
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteSpain
- Study dates
- 5 Oct 2016to 5 Oct 2021
- Phase
- Observational
- 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
Study population: Patients with prostate cancer
Who may be able to join
- Histologic confirmation of adenocarcinoma of the prostate by biopsy
- Performance Status 0-2
- Signed informed consent form
Who cannot join
- Positive lymph-nodes or metastatic disease from prostate cancer on imaging studies
- Anticoagulant treatment, individual assessment of antiplatelet therapy
- Previous pelvic radiotherapy
- Previous surgery for prostate cancer
- Previous transurethral resection of the prostate
- History of Crohn's Disease or Ulcerative Colitis
Show all 10Show fewer
- Antecedents of rectal fistulas in the last 10 years
- Previous significant urinary obstructive symptoms
- Previous chemotherapeutic treatments
- Non-compliance with constraints established in this protocol (see special section
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hypofractionated Radiotherapy for Prostate Cancer in 20 Sessions
Radiotherapy is a standard definitive treatment for men with localized prostate cancer.
Recent improvements in technology allow high doses of radiation to be delivered to the prostate in less days with lower doses to surrounding healthy tissues, trying to reduce side effects.
This study is being proposed to evaluate the use of moderate hypofractionated volumetric radiotherapy in localized prostate cancer patients and assessing treatment -related later adverse events using the CTCAE 4.0
Read the detailed description
Recent evidence suggests that the same or better outcomes might be achieved in prostate cancer by ussing a higher dose of radiation per fraction ( 3Gy) with the consequent decrease in total days Quality of life outcomes as well as gastrointestinal and genitourinary late toxicities will be analyzed.
It is thought that this regimen will produce comparable findings and would result in substantial health care cost savings, as well as, be more convenient for patients.
- Conditions
- Prostate Cancer
- Being tested
- Hypofractionated volumetric radiotherapy in 20 fractions
- Keywords
- HYPOFRACTIONED
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypofractionated volumetric radiotherapy in 20 fractionsRadiation
Hypofractionated radiotherapy at 3 Gy per fraction for localized prostate cancer.
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-related adverse events assessed by CTCAE v4.0
Number of patients with treatment-related adverse events as assessed by Common Toxicity Criteria for Adverse Effects v4.0
Measured: Participants should be followed continuously, for the duration of 10 years
Secondary outcomes (1)
Biochemical relapse free survival
By Phoenix definition ( Nadir + 2 ng/ml) Participants should be followed at baseline and follow-up, for the duration of 10 years
Measured: Participants should be followed continuously, for the duration of 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2019
- Study start5 Oct 2016
- Primary completion5 Oct 2021
- Study completion5 Oct 2021
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Consorci Sanitari de Terrassa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicolas Feltes, Consorci Sanitari de Terrassa
- Investigators
- NICOLAS FELTES, Study director, Consorci Sanitari de Terrassa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03851926
- Sponsor's protocol ID
- ONCORTCST2019-1
- Acronym
- HRT20
- Status last verified
- Feb 2023
- First submitted
- 19 Feb 2019
- Last updated
- 10 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypofractionated Radiotherapy for Prostate Cancer in 20 Sessions
- ClinicalTrials.gov ID
- NCT03851926
- Acronym / sponsor ID
- HRT20 / ONCORTCST2019-1
- Conditions
- Prostate Cancer
- Keywords
- HYPOFRACTIONED
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Consorci Sanitari de TerrassaUniversity, hospital or other
- Study start
- 5 Oct 2016 (actual)
- Primary completion
- 5 Oct 2021 (actual)
- Study completion
- 5 Oct 2021 (actual)
- First posted
- 22 Feb 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.
Radiotherapy is a standard definitive treatment for men with localized prostate cancer.
Recent improvements in technology allow high doses of radiation to be delivered to the prostate in less days with lower doses to surrounding healthy tissues, trying to reduce side effects.
This study is being proposed to evaluate the use of moderate hypofractionated volumetric radiotherapy in localized prostate cancer patients and assessing treatment -related later adverse events using the CTCAE 4.0
Detailed description
Recent evidence suggests that the same or better outcomes might be achieved in prostate cancer by ussing a higher dose of radiation per fraction ( 3Gy) with the consequent decrease in total days Quality of life outcomes as well as gastrointestinal and genitourinary late toxicities will be analyzed.
It is thought that this regimen will produce comparable findings and would result in substantial health care cost savings, as well as, be more convenient for patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with prostate cancer
Key inclusion criteria (3 listed)
- Histologic confirmation of adenocarcinoma of the prostate by biopsy
- Performance Status 0-2
- Signed informed consent form
Key exclusion criteria (10 listed)
- Positive lymph-nodes or metastatic disease from prostate cancer on imaging studies
- Anticoagulant treatment, individual assessment of antiplatelet therapy
- Previous pelvic radiotherapy
- Previous surgery for prostate cancer
- Previous transurethral resection of the prostate
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 |
|---|---|---|
| Hypofractionated volumetric radiotherapy in 20 fractionsHypofractionated radiotherapy at 3 Gy per fraction for localized prostate cancer. | Radiation | – |
Primary outcome
Treatment-related adverse events assessed by CTCAE v4.0
Time frame: Participants should be followed continuously, for the duration of 10 years
Number of patients with treatment-related adverse events as assessed by Common Toxicity Criteria for Adverse Effects v4.0
1 secondary outcome
Biochemical relapse free survival
Time frame: Participants should be followed continuously, for the duration of 10 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 10 Feb 2023.
- Individual participant dataSharing planned: Undecided
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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.
NICOLAS FELTES study director
Consorci Sanitari de Terrassa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Consorci Sanitari de Terrassa at 1 site in Spain.
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 3 inclusion and 10 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 10 Feb 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 Spain. 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?
Treatment-related adverse events assessed by CTCAE v4.0 (time frame: Participants should be followed continuously, for the duration of 10 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 10 Feb 2023.