Prostate CancerPhase 1/2NCT00214097
Phase I/II Hypofractionated Radiotherapy for Prostate Cancer
A Phase 1/2 study testing Radiotherapy in people with Prostate Cancer, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The purpose of this study is to examine the clinical feasibility of using Intensity-modulated radiation therapy (IMRT) combined with daily pretreatment prostate localization to deliver increasingly hypofractionated treatment courses. 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?
- Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 347 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Oct 2002to 21 Aug 2017
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Histologically proven adenocarcinoma of the prostate.
- Stage ≤ T2b disease, as defined by 1997 American Joint Committee on Cancer (AJCC) classification
- Predicted risk of lymph node involvement (by standard nomograms) of 15% or less (24), OR histologically negative pelvic nodes
- Gleason score ≤ 7
- No evidence of distant metastasis
- Age 18+
Show all 17Show fewer
- Informed consent signed in accordance with institutional protocol
- Pretreatment evaluations must be completed as specified in Section 7.0.
- ECOG performance status 0-1
- No previous or concurrent cancers, other than localized basal cell or squamous cell skin carcinoma, unless continually disease free for at least 5 years
- No prior pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy
- Gonadotropin-releasing hormone agonist (GnRH-a) use permitted (maximum of 6 months duration). Anti-androgen therapy permitted concurrently with GnRH-a.
- No previous or concurrent cytotoxic chemotherapy
- No radical surgery or cryosurgery for prostate cancer
- The absence of any co-morbid medical condition which would constitute a contraindication for radical radiotherapy
- The absence of serious concurrent illness of psychological, familial, sociological, geographical or other concomitant conditions which do not permit adequate follow-up and compliance with the study protocol.
- No current use of anticoagulation therapy, other than aspirin.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792
About this study
Official title: Phase I/II Trial Examining Dose-per-Fraction Escalation Using Intensity Modulated Radiation Therapy in the Treatment of Prostate Cancer
The purpose of this study is to examine the clinical feasibility of using Intensity-modulated radiation therapy (IMRT) combined with daily pretreatment prostate localization to deliver increasingly hypofractionated treatment courses. Progressively larger fraction sizes will be delivered in a phase I design based on both acute and long-term tolerances to the treatment. The dose-per-fraction escalation design utilizes schemas that maintain an isoeffective dose for late effects, while predicting that tumor control will actually improve. The delivery of fewer, larger fractions of radiation, if proven effective and safe, would result in significant cost saving and more efficient use of resources. Phase II will commence with Maximum Tolerated Dose (MTD) finding with up to 200 additional patients being enrolled during this phase of the study.
- Conditions
- Prostate Cancer
- Being tested
- 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.
RadiotherapyRadiation
Daily radiation to prescribed dose
| Study group | Role | What they receive |
|---|---|---|
| Level 1 | Experimental | 64.7 Gy/22 fractions of 2.94 Gy Receives: Radiation: Radiotherapy |
| Level 2 | Experimental | 58.08 Gy/16 fractions of 3.63 Gy Receives: Radiation: Radiotherapy |
| Level 3 | Experimental | 51.6 Gy/12 fractions of 4.3 Gy Receives: Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Experience Grade 3 or Higher Acute Toxicities
To evaluate acute tolerances to dose-per-fraction escalation in the treatment of prostate cancer using optimized treatment of Intensity-modulated radiation therapy (IMRT), daily rectal balloon displacement, and transabdominal ultrasound localization of the prostate. For toxicities observed within the first 10 patients at each hypofractionation level, ≥20% acute grade 3 or higher GI or genitourinary (GU) toxicity will constitute a threshold toxicity level and will dictate a decrease in frequency of treatment by one treatment per week. Maximum tolerated dose is reached if 20% of participants experience acute toxicities grade 3 or higher.
Measured: 90 days post radiation treatment
Number of Subjects Experiencing Grade 2 or Higher Late Rectal Toxicities at Any Time During Follow Up
To evaluate late radiation toxicities to dose-per fraction escalation in the treatment of prostate
Measured: from 90 days post XRT through last follow-up visit (up to 3 years)
Secondary outcomes (5)
Biochemical Progression-free Survival Based on PSA Surveillance
Patients will be considered to be without biochemical recurrence if either the Prostate-specific antigen (PSA) is still declining or the PSA nadir has been reached and is below 1.0ng/ml
Measured: up to 15 years from enrollment
Fox Chase Bowel Survey at Baseline and 3 Years
The Fox Chase Bowel/Bladder survey was divided into two sections: Bowel (questions 1 to 14, N=14) and Bladder (questions 19, and 21 to 30, N=11). To facilitate analysis, Bowel and Bladder scores for each section were rescaled to a total score of between 0 - 100, where higher scores indicated better Quality of Life (QoL). Results for the Bowel Section are reported here.
Measured: Baseline and 3 years
Fox Chase Bladder Survey at Baseline and 3 Years
The Fox Chase Bowel/Bladder survey was divided into two sections: Bowel (questions 1 to 14, N=14) and Bladder (questions 19, and 21 to 30, N=11). To facilitate analysis, Bowel and Bladder scores for each section were rescaled to a total score of between 0 - 100, where higher scores indicated better Quality of Life. Results for the Bladder Section are reported here.
Measured: Baseline and 3 years
International Index of Erectile Function (IIEF) Score at Baseline and 3 Years
The IIEF is a 15-item survey where 9-items are scored 0-5 and 6-items are scored 1-5 with a total range of 6-75. The standard scoring mechanism was used for IIEF, where the QoL items corresponded to the following domains: erectile function (score range 1-30), orgasmic function (score range 1-10), sexual desire (score range 2-10), intercourse satisfaction (score range 0-15), and overall satisfaction (score range 2-10). Higher numbers indicate increased QoL.
Measured: Baseline and 3 years
Spritzer Quality of Life Index (SQLI) at Baseline and 3 Years
The SQLI is composed of five items (activity, daily living, health, support, outlook) scored utilizing a numerical scale of 0-2. Standard scoring was also used for the SQLI survey (total score range 0-10) where higher score indicate increased QoL.
Measured: Baseline and 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study start14 Oct 2002
- Primary completion21 Aug 2017
- Study completion21 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- dose escalation, 3 possible dose groups, with one Phase II group based on MTD. Per protocol, while waiting for safety data to mature for escalation, protocol permitted enrollment to continue on last dose that was already proven safe. Thus Arms one and two have more than 50 subjects each.
- Masking
- None (open label)
- Enrolment
- 347 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark Ritter, MD, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00214097
- Sponsor's protocol ID
- RO02803
- Other IDs
- NCI (P01 CA88960), 2002-322, A533300, SMPH/HUMAN ONCOLOGY
- Status last verified
- Sep 2019
- First submitted
- 13 Sep 2005
- Last updated
- 25 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Brower JV, Forman JD, Kupelian PA, Petereit DG, Gondi V, Lawton CA, Anger N, Saha S, Chappell R, Ritter MA. Quality of life outcomes from a dose-per-fraction escalation trial of hypofractionation in prostate cancer. Radiother Oncol. 2016 Jan;118(1):99-104. doi: 10.1016/j.radonc.2015.12.018. Epub 2016 Jan 2.
PubMed 26755165
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Trial Examining Dose-per-Fraction Escalation Using Intensity Modulated Radiation Therapy in the Treatment of Prostate Cancer
- ClinicalTrials.gov ID
- NCT00214097
- Acronym / sponsor ID
- RO02803
- Conditions
- Prostate Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 347 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 14 Oct 2002 (actual)
- Primary completion
- 21 Aug 2017 (actual)
- Study completion
- 21 Aug 2017 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Posted 22 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine the clinical feasibility of using Intensity-modulated radiation therapy (IMRT) combined with daily pretreatment prostate localization to deliver increasingly hypofractionated treatment courses. Progressively larger fraction sizes will be delivered in a phase I design based on both acute and long-term tolerances to the treatment. The dose-per-fraction escalation design utilizes schemas that maintain an isoeffective dose for late effects, while predicting that tumor control will actually improve. The delivery of fewer, larger fractions of radiation, if proven effective and safe, would result in significant cost saving and more efficient use of resources. Phase II will commence with Maximum Tolerated Dose (MTD) finding with up to 200 additional patients being enrolled during this phase of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- dose escalation, 3 possible dose groups, with one Phase II group based on MTD. Per protocol, while waiting for safety data to mature for escalation, protocol permitted enrollment to continue on last dose that was already proven safe. Thus Arms one and two have more than 50 subjects each.
| Arm | Type | Receives |
|---|---|---|
| Level 1 | Experimental | Radiation: Radiotherapy64.7 Gy/22 fractions of 2.94 Gy |
| Level 2 | Experimental | Radiation: Radiotherapy58.08 Gy/16 fractions of 3.63 Gy |
| Level 3 | Experimental | Radiation: Radiotherapy51.6 Gy/12 fractions of 4.3 Gy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Histologically proven adenocarcinoma of the prostate.
- Stage ≤ T2b disease, as defined by 1997 American Joint Committee on Cancer (AJCC) classification
- Predicted risk of lymph node involvement (by standard nomograms) of 15% or less (24), OR histologically negative pelvic nodes
- Gleason score ≤ 7
- No evidence of distant metastasis
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| RadiotherapyDaily radiation to prescribed dose | Radiation | Level 1, Level 2, Level 3 |
Primary outcome
Number of Participants Who Experience Grade 3 or Higher Acute Toxicities
Time frame: 90 days post radiation treatment
To evaluate acute tolerances to dose-per-fraction escalation in the treatment of prostate cancer using optimized treatment of Intensity-modulated radiation therapy (IMRT), daily rectal balloon displacement, and transabdominal ultrasound localization of the prostate. For toxicities observed within the first 10 patients at each hypofractionation level, ≥20% acute grade 3 or higher GI or genitourinary (GU) toxicity will constitute a threshold toxicity level and will dictate a decrease in frequency of treatment by one treatment per week. Maximum tolerated dose is reached if 20% of participants experience acute toxicities grade 3 or higher.
Number of Subjects Experiencing Grade 2 or Higher Late Rectal Toxicities at Any Time During Follow Up
Time frame: from 90 days post XRT through last follow-up visit (up to 3 years)
To evaluate late radiation toxicities to dose-per fraction escalation in the treatment of prostate
5 secondary outcomes
Biochemical Progression-free Survival Based on PSA Surveillance
Time frame: up to 15 years from enrollment
Fox Chase Bowel Survey at Baseline and 3 Years
Time frame: Baseline and 3 years
Fox Chase Bladder Survey at Baseline and 3 Years
Time frame: Baseline and 3 years
International Index of Erectile Function (IIEF) Score at Baseline and 3 Years
Time frame: Baseline and 3 years
Spritzer Quality of Life Index (SQLI) at Baseline and 3 Years
Time frame: Baseline and 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 26755165Brower JV, Forman JD, Kupelian PA, Petereit DG, Gondi V, Lawton CA, Anger N, Saha S, Chappell R, Ritter MA. Quality of life outcomes from a dose-per-fraction escalation trial of hypofractionation in prostate cancer. Radiother Oncol. 2016 Jan;118(1):99-104. doi: 10.1016/j.radonc.2015.12.018. Epub 2016 Jan 2.
- University of Wisconsin Carbone Cancer CenterLink provided by the sponsor.
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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.
Mark Ritter, MD, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Radiotherapy in people with Prostate Cancer, run by University of Wisconsin, Madison at 1 site in United States.
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 17 inclusion and 0 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 25 Nov 2019. 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 United States. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Yes. Results are posted in the registry (first posted 22 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Who Experience Grade 3 or Higher Acute Toxicities (time frame: 90 days post radiation 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?
On the ClinicalTrials.gov record for NCT00214097, which also lists 1 linked publication.
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 25 Nov 2019.