Prostate CancerPhase 1/2HypoFXNCT01868386
Shorter Duration Radiotherapy to Treat Prostate Cancer After Removal of the Prostate
A Phase 1/2 study testing Hypofractionated therapy in people with Prostate Cancer, run by Timothy Showalter, MD at 3 sites in United States.
Trial summary
Radiation therapy is one of the standard treatments for men with prostate cancer who have detectable levels of prostate specific antigen (PSA, a prostate cancer specific marker) after surgery. 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 therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2013to Dec 2020
- Phase
- Phase 1/2
- 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
Who may be able to join
- diagnosis of prostate adenocarcinoma and
- have had a prostatectomy
- have detectable PSA
- 18 years of age or older
Who cannot join
- are receiving chemotherapy or other agents intended for cancer treatment
- history of rectal surgery or lower gastrointestinal bleed
- history of bleeding diathesis or abnormal sensitivity to ionizing radiation
- had prior pelvic irradiation or are scheduled to receive pelvic nodal irradiation
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Virginia Health System
Charlottesville, Virginia, 22908
Southwest Virginia Regional Cancer Center
Norton, Virginia, 24273
Virginia Commonwealth University
Richmond, Virginia, 23220
About this study
Official title: Hypofractionated Post-prostatectomy Radiotherapy for Prostate Cancer to Reduce Toxicity and Improve Patient Convenience: A Phase I/II Trial
Radiation therapy is one of the standard treatments for men with prostate cancer who have detectable levels of prostate specific antigen (PSA, a prostate cancer specific marker) after surgery. When radiation therapy is given to patients who have an increase in PSA after surgery, it is called "salvage radiation therapy". Currently the standard radiation therapy course length for this type of cancer is around 7 ½ -8 weeks. Sometimes, radiation therapy after prostate removal causes unpleasant side effects. A shorter course of radiation therapy, known as a "hypofractionated" course, gives fewer but higher doses of radiation than standard radiation.
The purpose of this study is to test the safety of a shorter course of radiation therapy at progressively lower dose levels and shorter lengths of treatment (hypofractionated) with patients who have had their prostate removed. The study will assess whether the hypofractionated course works better without causing additional side effects to the remaining cancer cells in the prostate bed.
Read the detailed description
Primary Objectives:
To determine the shortest dose-fractionation schedule (Dose Schedule) with acceptable grade ¡Ã 3 GU/GI toxicity rate for salvage HypoFx RT to maintain a constant, high BED for prostate cancer response while reducing the BED for late GU and GI toxicity
To assess health-related quality of life (HRQOL) of the recommended Dose Schedule of salvage HypoFx RT by demonstrating no significant change in 1-year disease specific QoL, as compared to baseline
Secondary Objectives:
To evaluate and characterize the acute and late genitourinary (GU) and gastrointestinal (GI) adverse effects associated with postoperative, hypofractionated radiation therapy.
To evaluate biochemical failure rate, defined separately as nadir plus 2 ng/mL and as three consecutive rises in PSA, at 2 years after hypofractionated, post-prostatectomy radiation therapy.
To evaluate health utilities at 1 year after HypoFx salvage RT, as measured by the EQ-5D instrument.
To evaluate changes in sexual domain of EPIC quality of life instrument at 1 year after HypoFx salvage RT.
To evaluate the treatment burden for patients undergoing salvage HypoFx RT, in order to examine whether HypoFx RT results in less burdensome treatment for patients, as measured by patient-reported direct and indirect (i.e., transportation) health care costs and lost productivity due to treatment, as evaluated by the Work Productivity and Activity Impairment Questionnaire¢-General Health (WPAI-GH).
- Conditions
- Prostate Cancer
- Being tested
- Hypofractionated therapy
- Keywords
- Radiotherapy, hypofractionated, Salvage therapy, Radiotherapy, adjuvant
- 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 therapyRadiation
Shorter courses of increasing doses of radiation therapy will be assessed in each subsequent arm
| Study group | Role | What they receive |
|---|---|---|
| Dose Level 1 | Experimental | Hypofractionated therapy, 26 treatments at 2.5 Gy Receives: Radiation: Hypofractionated therapy |
| Dose Level 2 | Experimental | Hypofractionated therapy, 20 treatments at 2.83Gy Receives: Radiation: Hypofractionated therapy |
| Dose Level 3 | Experimental | Hypofractionated therapy,15 treatments at 3.36 Gy Receives: Radiation: Hypofractionated therapy |
| Dose Level 4 | Experimental | Hypofractionated therapy, 10 treatments at 4.26 Gy Receives: Radiation: Hypofractionated therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicity
Incidence of GU (genitourinary) and GI (gastrointestinal) toxicities of CTCAE (Common Terminology Criteria for Adverse Events) grade 3 or greater
Measured: over a period of 2 years
Quality of life measure
To compare quality of life post-procedure from baseline
Measured: over a period of 2 years
Secondary outcomes (1)
Biochemical failure rate
A biochemical failure is defined as an increase in prostate serum antigen concentration to nadir plus 2ng/mL or 3 consecutive increases in PSA
Measured: over a period of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2013 (estimated)
- Study startApr 2013
- Primary completionDec 2020
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Timothy Showalter, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Timothy Showalter, MD, University of Virginia
- Investigators
- Timothy Showalter, MD, Principal investigator, University of Virginia School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01868386
- Sponsor's protocol ID
- 16604
- Acronym
- HypoFX
- Status last verified
- Apr 2021
- First submitted
- 14 May 2013
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wages NA, Sanders JC, Smith A, Wood S, Anscher MS, Varhegyi N, Krupski TL, Harris TJ, Showalter TN. Hypofractionated Postprostatectomy Radiation Therapy for Prostate Cancer to Reduce Toxicity and Improve Patient Convenience: A Phase 1/2 Trial. Int J Radiat Oncol Biol Phys. 2021 Apr 1;109(5):1254-1262. doi: 10.1016/j.ijrobp.2020.11.009. Epub 2020 Nov 21.
PubMed 33227441
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypofractionated Post-prostatectomy Radiotherapy for Prostate Cancer to Reduce Toxicity and Improve Patient Convenience: A Phase I/II Trial
- ClinicalTrials.gov ID
- NCT01868386
- Acronym / sponsor ID
- HypoFX / 16604
- Conditions
- Prostate Cancer
- Keywords
- Radiotherapy, hypofractionated, Salvage therapy, Radiotherapy, adjuvant
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Timothy Showalter, MDUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Dec 2020 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 4 Jun 2013 (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.
Radiation therapy is one of the standard treatments for men with prostate cancer who have detectable levels of prostate specific antigen (PSA, a prostate cancer specific marker) after surgery. When radiation therapy is given to patients who have an increase in PSA after surgery, it is called "salvage radiation therapy". Currently the standard radiation therapy course length for this type of cancer is around 7 ½ -8 weeks. Sometimes, radiation therapy after prostate removal causes unpleasant side effects. A shorter course of radiation therapy, known as a "hypofractionated" course, gives fewer but higher doses of radiation than standard radiation.
The purpose of this study is to test the safety of a shorter course of radiation therapy at progressively lower dose levels and shorter lengths of treatment (hypofractionated) with patients who have had their prostate removed. The study will assess whether the hypofractionated course works better without causing additional side effects to the remaining cancer cells in the prostate bed.
Detailed description
Primary Objectives:
To determine the shortest dose-fractionation schedule (Dose Schedule) with acceptable grade ¡Ã 3 GU/GI toxicity rate for salvage HypoFx RT to maintain a constant, high BED for prostate cancer response while reducing the BED for late GU and GI toxicity
To assess health-related quality of life (HRQOL) of the recommended Dose Schedule of salvage HypoFx RT by demonstrating no significant change in 1-year disease specific QoL, as compared to baseline
Secondary Objectives:
To evaluate and characterize the acute and late genitourinary (GU) and gastrointestinal (GI) adverse effects associated with postoperative, hypofractionated radiation therapy.
To evaluate biochemical failure rate, defined separately as nadir plus 2 ng/mL and as three consecutive rises in PSA, at 2 years after hypofractionated, post-prostatectomy radiation therapy.
To evaluate health utilities at 1 year after HypoFx salvage RT, as measured by the EQ-5D instrument.
To evaluate changes in sexual domain of EPIC quality of life instrument at 1 year after HypoFx salvage RT.
To evaluate the treatment burden for patients undergoing salvage HypoFx RT, in order to examine whether HypoFx RT results in less burdensome treatment for patients, as measured by patient-reported direct and indirect (i.e., transportation) health care costs and lost productivity due to treatment, as evaluated by the Work Productivity and Activity Impairment Questionnaire¢-General Health (WPAI-GH).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dose Level 1 | Experimental | Radiation: Hypofractionated therapyHypofractionated therapy, 26 treatments at 2.5 Gy |
| Dose Level 2 | Experimental | Radiation: Hypofractionated therapyHypofractionated therapy, 20 treatments at 2.83Gy |
| Dose Level 3 | Experimental | Radiation: Hypofractionated therapyHypofractionated therapy,15 treatments at 3.36 Gy |
| Dose Level 4 | Experimental | Radiation: Hypofractionated therapyHypofractionated therapy, 10 treatments at 4.26 Gy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- diagnosis of prostate adenocarcinoma and
- have had a prostatectomy
- have detectable PSA
- 18 years of age or older
Key exclusion criteria (4 listed)
- are receiving chemotherapy or other agents intended for cancer treatment
- history of rectal surgery or lower gastrointestinal bleed
- history of bleeding diathesis or abnormal sensitivity to ionizing radiation
- had prior pelvic irradiation or are scheduled to receive pelvic nodal irradiation
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 therapyShorter courses of increasing doses of radiation therapy will be assessed in each subsequent arm | Radiation | Dose Level 1, Dose Level 2, Dose Level 3, Dose Level 4 |
Primary outcome
Dose limiting toxicity
Time frame: over a period of 2 years
Incidence of GU (genitourinary) and GI (gastrointestinal) toxicities of CTCAE (Common Terminology Criteria for Adverse Events) grade 3 or greater
Quality of life measure
Time frame: over a period of 2 years
To compare quality of life post-procedure from baseline
1 secondary outcome
Biochemical failure rate
Time frame: over a period of 2 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 28 Apr 2021.
- Background: PubMed 33227441Wages NA, Sanders JC, Smith A, Wood S, Anscher MS, Varhegyi N, Krupski TL, Harris TJ, Showalter TN. Hypofractionated Postprostatectomy Radiation Therapy for Prostate Cancer to Reduce Toxicity and Improve Patient Convenience: A Phase 1/2 Trial. Int J Radiat Oncol Biol Phys. 2021 Apr 1;109(5):1254-1262. doi: 10.1016/j.ijrobp.2020.11.009. Epub 2020 Nov 21.
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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.
Timothy Showalter, MD principal investigator
University of Virginia School of Medicine
3 sites 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 Hypofractionated therapy in people with Prostate Cancer, run by Timothy Showalter, MD at 3 sites 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 4 inclusion and 4 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 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
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?
Dose limiting toxicity (time frame: over a period of 2 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?
On the ClinicalTrials.gov record for NCT01868386, 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 28 Apr 2021.