Prostate CancerNCT03233672
Hypo-fractionated Postoperative IMRT in Prostate Cancer
A study testing Hypo-fractionated postoperative IMRT-SIB in people with Prostate Cancer, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna.
Trial summary
To report the outcome of hypo-fractionated radiotherapy after radical prostatectomy (RP) for prostate cancer (PCa) using IMRT-SIB. 124 patients with PCa at high risk of relapse after RP or diagnosis of biochemical relapse were included. Read more about this study
- Who is it for?
- Ages 18 to 79 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Hypo-fractionated postoperative IMRT-SIB
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- No sites listed yet
- Study dates
- 18 Sep 2007to 18 Sep 2014
- 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 79 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 18 years
- prior radical prostatectomy with or without lymphadenectomy
- high-risk patients (positive surgical margins, and/or extracapsular extension, and/or seminal vescicle invasion, and/or probability of nodal metastasis > 7% calculated by the Roach formula after pelvic lymph node dissection with ≤ 13 nodes removed, and/or presence of any positive pelvic nodes) or patients with biochemical relapse (initial post-surgery serum PSA equal or above 0.2 ng/mL with a second confirmatory PSA of the same value)
- ECOG performance status 0-1
- adequate bone marrow function (hemoglobin concentration > 8 g/dl, white blood cell count > 3,000/ mm³, platelet count > 75,000/ mm³)
- pre-treatment computed tomography (CT) scan or magnetic resonance imaging (MRI) of the abdomen and pelvis
- bone scan
- informed consent
Who cannot join
- prior pelvic radiotherapy
- distant metastases
- macroscopic residual tumor
- pelvic or para-aortic nodes at re-evaluation imaging after surgery
- secondary malignancies
- genetic syndromes of hyper-radio-sensitivity
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- chronic inflammatory bowel disease
- previously treated with androgen deprivation therapy
- previously treated with chemotherapy for prostate cancer
About this study
Official title: Hypofractionated Post-operative IMRT in Prostate Carcinoma: a Phase I/II Study
To report the outcome of hypo-fractionated radiotherapy after radical prostatectomy (RP) for prostate cancer (PCa) using IMRT-SIB. 124 patients with PCa at high risk of relapse after RP or diagnosis of biochemical relapse were included. Patients received 62.5 Gy to the prostate bed (PB) and 45 Gy to pelvis nodes in 25 fractions. Androgen suppressive therapy was prescribed based on NCCN risk categories. Median follow-up was 30 months.
Read the detailed description
To report the outcome of hypo-fractionated radiation therapy after radical prostatectomy (RP) for prostate cancer (PCa) using intensity-modulated radiation treatment with simultaneous integrated boost (IMRT-SIB).
One hundred and twenty-four patients with PCa at high risk of relapse after RP or diagnosis of biochemical relapse were included in this phase II study (adjuvant: 106 patients, salvage: 18 patients). All patients received 62.5 Gy to the prostate bed (PB) and 45 Gy to pelvis nodes in 25 fractions. Androgen suppressive therapy was prescribed based on NCCN risk categories. Acute and late toxicities were recorded and evaluated according to RTOG (Radiation Therapy Oncology Group) criteria and RTOG-EORTC (European Organization for Research and Treatment of Cancer) scale, respectively.
Median follow-up was 30 months (13-92).
- Conditions
- Prostate Cancer
- Being tested
- Hypo-fractionated postoperative IMRT-SIB
- Keywords
- adjuvant, hypofractionation, IMRT, phase I-II, prostate neoplasms, 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.
Hypo-fractionated postoperative IMRT-SIBRadiation
intensity-modulated radiation treatment with simultaneous integrated boost
| Study group | Role | What they receive |
|---|---|---|
| Hypo-fractionated postoperative IMRT-SIB | Other | All patients underwent combined, intensified and modulated radiotherapy for five days a week with the following doses: 62.5 Gy to the prostate bed and 45 Gy to pelvis nodes in 25 fractions. Receives: Radiation: Hypo-fractionated postoperative IMRT-SIB |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of early treatment-emergent adverse events
adverse events after radiotherapy. Acute side effets were scored according to the Radiation Therapy Oncology Group (RTOG) scale.
Measured: < 90 days
Secondary outcomes (2)
Biochemical relapse free survival
Survival free from increase of PSA livel exceeding 0.2 ng/mL for those with post surgical PSA livel of 0.2 ng/mL or lower, and as two consecutive PSA increases for patients with a postsurgical PSA livel of > 0.2 ng/mL
Measured: 5 years
incidence of late treatment-emergent adverse events were assessed with Radiation
Late complications were assessed with delete Radiation Morbidity Scoring Scheme of the RTOG/European Organization for Research and Treatment of Cancer (EORTC)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2017
- Study start18 Sep 2007
- Primary completion18 Sep 2010
- Study completion18 Sep 2014
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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Sponsor type
- University, hospital or other
- Collaborators
- Catholic University of the Sacred Heart, University of Bologna, Howard University
- Responsible party
- Principal investigator, Alessio Giuseppe Morganti, IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Investigators
- Alessio G Morganti, MD, Study director, Radiation Oncology Center, Department of Experimental, Diagnostic and Speciality Medicine-DIMES, University of Bologna, S. Orsola-Malpighi Hospital, Bologna, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03233672
- Sponsor's protocol ID
- Iside-PP-2
- Status last verified
- Mar 2018
- First submitted
- 26 Jul 2017
- Last updated
- 6 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- 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 6 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypofractionated Post-operative IMRT in Prostate Carcinoma: a Phase I/II Study
- ClinicalTrials.gov ID
- NCT03233672
- Acronym / sponsor ID
- Iside-PP-2
- Conditions
- Prostate Cancer
- Keywords
- adjuvant, hypofractionation, IMRT, phase I-II, prostate neoplasms, radiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Collaborators
- Catholic University of the Sacred Heart, University of Bologna, Howard University
- Study start
- 18 Sep 2007 (actual)
- Primary completion
- 18 Sep 2010 (actual)
- Study completion
- 18 Sep 2014 (actual)
- First posted
- 28 Jul 2017 (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.
To report the outcome of hypo-fractionated radiotherapy after radical prostatectomy (RP) for prostate cancer (PCa) using IMRT-SIB. 124 patients with PCa at high risk of relapse after RP or diagnosis of biochemical relapse were included. Patients received 62.5 Gy to the prostate bed (PB) and 45 Gy to pelvis nodes in 25 fractions. Androgen suppressive therapy was prescribed based on NCCN risk categories. Median follow-up was 30 months.
Detailed description
To report the outcome of hypo-fractionated radiation therapy after radical prostatectomy (RP) for prostate cancer (PCa) using intensity-modulated radiation treatment with simultaneous integrated boost (IMRT-SIB).
One hundred and twenty-four patients with PCa at high risk of relapse after RP or diagnosis of biochemical relapse were included in this phase II study (adjuvant: 106 patients, salvage: 18 patients). All patients received 62.5 Gy to the prostate bed (PB) and 45 Gy to pelvis nodes in 25 fractions. Androgen suppressive therapy was prescribed based on NCCN risk categories. Acute and late toxicities were recorded and evaluated according to RTOG (Radiation Therapy Oncology Group) criteria and RTOG-EORTC (European Organization for Research and Treatment of Cancer) scale, respectively.
Median follow-up was 30 months (13-92).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypo-fractionated postoperative IMRT-SIB | Other | Radiation: Hypo-fractionated postoperative IMRT-SIBAll patients underwent combined, intensified and modulated radiotherapy for five days a week with the following doses: 62.5 Gy to the prostate bed and 45 Gy to pelvis nodes in 25 fractions. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- > 18 years
- prior radical prostatectomy with or without lymphadenectomy
- high-risk patients (positive surgical margins, and/or extracapsular extension, and/or seminal vescicle invasion, and/or probability of nodal metastasis > 7% calculated by the Roach formula after pelvic lymph node dissection with ≤ 13 nodes removed, and/or presence of any positive pelvic nodes) or patients with biochemical relapse (initial post-surgery serum PSA equal or above 0.2 ng/mL with a second confirmatory PSA of the same value)
- ECOG performance status 0-1
- adequate bone marrow function (hemoglobin concentration > 8 g/dl, white blood cell count > 3,000/ mm³, platelet count > 75,000/ mm³)
Key exclusion criteria (9 listed)
- prior pelvic radiotherapy
- distant metastases
- macroscopic residual tumor
- pelvic or para-aortic nodes at re-evaluation imaging after surgery
- secondary malignancies
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 |
|---|---|---|
| Hypo-fractionated postoperative IMRT-SIBintensity-modulated radiation treatment with simultaneous integrated boost | Radiation | Hypo-fractionated postoperative IMRT-SIB |
Primary outcome
incidence of early treatment-emergent adverse events
Time frame: < 90 days
adverse events after radiotherapy. Acute side effets were scored according to the Radiation Therapy Oncology Group (RTOG) scale.
2 secondary outcomes
Biochemical relapse free survival
Time frame: 5 years
incidence of late treatment-emergent adverse events were assessed with Radiation
Time frame: 5 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 6 Mar 2018.
- 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.
Alessio G Morganti, MD study director
Radiation Oncology Center, Department of Experimental, Diagnostic and Speciality Medicine-DIMES, University of Bologna, S. Orsola-Malpighi Hospital, Bologna, Italy
Questions about this trial
What is this clinical trial studying?
A study testing Hypo-fractionated postoperative IMRT-SIB in people with Prostate Cancer, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna.
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 9 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 6 Mar 2018. 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?
incidence of early treatment-emergent adverse events (time frame: < 90 days). 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 6 Mar 2018.