Prostate AdenocarcinomaNCT02254746
A Phase I-II Dose Escalation Study of Stereotactic Body Radiation Therapy in Patients With Localized Prostate Cancer
A study testing Stereotactic Body Radiation Therapy (SBRT) in people with Prostate Adenocarcinoma, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
Trial summary
The aim of this study is to test the safety and efficacy of Stereotactic Body Radiation Therapy (SBRT) in localized prostate carcinoma in patients for whom the standard treatment is the irradiation of the entire prostate gland with or without seminal vesicles accompanied or not by hormonal therapy. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Prostate Adenocarcinoma
- What is being tested?
- Stereotactic Body Radiation Therapy (SBRT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteSwitzerland
- Study dates
- Aug 2014to 8 Nov 2023
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients must be willing and capable to provide informed consent
- Histologic confirmation of prostate adenocarcinoma
- T2-T3 tumors, N0 (clinically by no evidence of metastatic lymph nodes on CT or MRI)
- No direct evidence of regional or distant metastases
- PSA less than or equal to 50 μg/ml
- Visible gross tumor at the prostate endorectal coil MRI.
Show all 15Show fewer
- The ultrasound or MRI based volume estimation of the patient's prostate gland no greater than 70g or 70cc
- No significant urinary obstructive symptoms; IPSS score must be ≤ 15 (alpha blockers allowed)
- Patient must have undergone an endorectal coil magnetic resonance image (MRI) of the prostatic gland (before rectal spacer if any),
- Patient must have undergone the following assessments in case of PSA ≥ 20μg/L, and/or T3 tumor and/or Gleason Score ≥ 8:
- bone scan
- Chest abdominal and pelvis computed tomography (CT) scan
- If tumor is localized at less than 3 mm from the rectum a rectal spacer is mandatory. Patient accepts the rectal spacer to be injected before treatment starts
- Patient accepts to have one planning MRI after the injection of rectal spacer (without endorectal coil)
- Patient accepts the preparation of the bladder (bladder full), before the planning MRI, planning CT and then before each treatment fraction
Who cannot join
- Previous radiotherapy in the pelvis
- Tumor localized at less than 3 mm from the urethra
- History of inflammatory colitis (including Crohn's disease and ulcerative colitis)
- Prior cancer in the pelvis
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before inclusion in the trial
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to test the safety and efficacy of Stereotactic Body Radiation Therapy (SBRT) in localized prostate carcinoma in patients for whom the standard treatment is the irradiation of the entire prostate gland with or without seminal vesicles accompanied or not by hormonal therapy. In light of the accumulating clinical evidence favoring the use of hypo fractionation, SBRT regimen might constitute a much more convenient non-invasive and highly efficient outpatient therapy.
Read the detailed description
Primary objective phase I:
To irradiate the prostate gland which might albeit contain microscopic disease with tumoricidal doses of SBRT, and to escalate the dose of SBRT in the visible prostatic tumor towards the best tumoricidal dose without exceeding the normal tissue tolerance and toxicity in patients with organ confined T2-T3 N0 prostate carcinoma.
Primary objective phase II:
To determine the rate of acute toxicity grade 2 or more defined as toxicity occurring immediately after the first fraction of radiotherapy and up to 90 days after the start of radiotherapy treatment.
Secondary objectives phase II:
- To determine efficacy measured by PSA failure using Phoenix definition.
- To determine long-term late toxicity (>90 days after treatment start).
Exploratory endpoint phase II:
- To determine the feasibility of achieving dose constraints in the organs at risk using high technology radiotherapy.
- Conditions
- Prostate Adenocarcinoma
- Being tested
- Stereotactic Body Radiation Therapy (SBRT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Body Radiation Therapy (SBRT)Radiation
| Study group | Role | What they receive |
|---|---|---|
| Phase I (dose escalation)/ Phase II | Experimental | Phase I
* Prostate tumor: starting dose 9 Gy per fraction in 5 fractions (total 45 Gy) and subsequent dose escalation up to 10 Gy.
* Prostate gland: fixed prophylactic tumoricidal dose 7.25 Gy per fraction in 5 fractions (no dose escalation). Total 36.25 Gy.
Phase II
Additional patients will be treated at either the maximum tolerated dose (MTD) or at the highest dose level as determined by the investigators from the Phase I portion of the study. Receives: Radiation: Stereotactic Body Radiation Therapy (SBRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (phase I)
Observation of dose-limiting toxicities (DLT) defined as any treatment-related grade ≥ 3 acute toxicity occurring in the radiation field or irradiated volumes in the following categories GI or GU. In addition, any other grade 4 or 5 toxicity attributed to the therapy constitutes a DLT.
Measured: During the first 30 days from the start of treatment
Toxicity (phase II)
Acute GU and GI toxicity (grade 2 or more) according to the NCI CTCAE v4.0.
Measured: 90 days after the first fraction of radiotherapy treatment
Secondary outcomes (2)
Efficacy (phase II)
PSA failure using Phoenix definition
Measured: 3 monthly assessments during the first 2 years and 6 monthly assessments until end of study (5 years)
Toxicity (phase II)
Long term GU and GI toxicity (grade 2 or more) according to the NCI CTCAE v4.0.
Measured: > 90 days and up to 5 years from the start of protocol treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2014 (estimated)
- Study startAug 2014
- Primary completionApr 2017
- Study completion8 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire VaudoisThe 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
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Fernanda Herrera, Centre Hospitalier Universitaire Vaudois
- Investigators
- Fernanda Herrera, MD, Principal investigator, CHUV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02254746
- Sponsor's protocol ID
- CHUV-DO-HYPORT-2013
- Status last verified
- Feb 2025
- First submitted
- 16 Sep 2014
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I-II Dose Escalation Study of Stereotactic Body Radiation Therapy in Patients With Localized Prostate Cancer
- ClinicalTrials.gov ID
- NCT02254746
- Acronym / sponsor ID
- CHUV-DO-HYPORT-2013
- Conditions
- Prostate Adenocarcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Study start
- Aug 2014 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- 8 Nov 2023 (actual)
- First posted
- 2 Oct 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.
The aim of this study is to test the safety and efficacy of Stereotactic Body Radiation Therapy (SBRT) in localized prostate carcinoma in patients for whom the standard treatment is the irradiation of the entire prostate gland with or without seminal vesicles accompanied or not by hormonal therapy. In light of the accumulating clinical evidence favoring the use of hypo fractionation, SBRT regimen might constitute a much more convenient non-invasive and highly efficient outpatient therapy.
Detailed description
Primary objective phase I:
To irradiate the prostate gland which might albeit contain microscopic disease with tumoricidal doses of SBRT, and to escalate the dose of SBRT in the visible prostatic tumor towards the best tumoricidal dose without exceeding the normal tissue tolerance and toxicity in patients with organ confined T2-T3 N0 prostate carcinoma.
Primary objective phase II:
To determine the rate of acute toxicity grade 2 or more defined as toxicity occurring immediately after the first fraction of radiotherapy and up to 90 days after the start of radiotherapy treatment.
Secondary objectives phase II:
- To determine efficacy measured by PSA failure using Phoenix definition.
- To determine long-term late toxicity (>90 days after treatment start).
Exploratory endpoint phase II:
- To determine the feasibility of achieving dose constraints in the organs at risk using high technology radiotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Phase I (dose escalation)/ Phase II | Experimental | Radiation: Stereotactic Body Radiation Therapy (SBRT)Phase I * Prostate tumor: starting dose 9 Gy per fraction in 5 fractions (total 45 Gy) and subsequent dose escalation up to 10 Gy. * Prostate gland: fixed prophylactic tumoricidal dose 7.25 Gy per fraction in 5 fractions (no dose escalation). Total 36.25 Gy. Phase II Additional patients will be treated at either the maximum tolerated dose (MTD) or at the highest dose level as determined by the investigators from the Phase I portion of the study. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- All patients must be willing and capable to provide informed consent
- Histologic confirmation of prostate adenocarcinoma
- T2-T3 tumors, N0 (clinically by no evidence of metastatic lymph nodes on CT or MRI)
- No direct evidence of regional or distant metastases
- PSA less than or equal to 50 μg/ml
Key exclusion criteria (5 listed)
- Previous radiotherapy in the pelvis
- Tumor localized at less than 3 mm from the urethra
- History of inflammatory colitis (including Crohn's disease and ulcerative colitis)
- Prior cancer in the pelvis
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before inclusion in the trial
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 Radiation Therapy (SBRT) | Radiation | Phase I (dose escalation)/ Phase II |
Primary outcome
Maximum tolerated dose (phase I)
Time frame: During the first 30 days from the start of treatment
Observation of dose-limiting toxicities (DLT) defined as any treatment-related grade ≥ 3 acute toxicity occurring in the radiation field or irradiated volumes in the following categories GI or GU. In addition, any other grade 4 or 5 toxicity attributed to the therapy constitutes a DLT.
Toxicity (phase II)
Time frame: 90 days after the first fraction of radiotherapy treatment
Acute GU and GI toxicity (grade 2 or more) according to the NCI CTCAE v4.0.
2 secondary outcomes
Efficacy (phase II)
Time frame: 3 monthly assessments during the first 2 years and 6 monthly assessments until end of study (5 years)
Toxicity (phase II)
Time frame: > 90 days and up to 5 years from the start of protocol treatment
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 14 Feb 2025.
- 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.
Fernanda Herrera, MD principal investigator
CHUV
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stereotactic Body Radiation Therapy (SBRT) in people with Prostate Adenocarcinoma, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
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 15 inclusion and 5 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 14 Feb 2025. 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 Switzerland. 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?
Maximum tolerated dose (phase I) (time frame: During the first 30 days from the start of treatment). 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 14 Feb 2025.