Stage II Prostate AdenocarcinomaNCT02446366
Hypofractionated Stereotactic Body Radiation Therapy for Patients With Prostate Cancer That Was Removed by Surgery
A study testing Laboratory Biomarker Analysis, Quality-of-Life Assessment and Stereotactic Body Radiation Therapy in people with Stage II Prostate Adenocarcinoma and Stage IIB Prostate Cancer, run by University of Southern California at 1 site in United States.
Trial summary
This phase I trial studies the side effects and the best dose of hypofractionated stereotactic body radiation therapy (SBRT) in treating patients with prostate cancer that was removed by surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Stage II Prostate Adenocarcinoma, Stage IIB Prostate Cancer, Stage III Prostate Adenocarcinoma
- What is being tested?
- Laboratory Biomarker Analysis, Quality-of-Life Assessment and Stereotactic Body Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 12 May 2015to 12 Feb 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adenocarcinoma of the prostate treated primarily with radical prostatectomy
- Any type of radical prostatectomy is permitted including retropubic, perineal, laparoscopic or robotically assisted; there is no time limit for the date of radical prostatectomy
- One of the following pathologic classifications
- T3N0 disease with or without a positive surgical margin or
- T2N0 disease with or without a positive surgical margin
- Those with T2N0 disease and a negative margin must have a detectable prostate-specific antigen (PSA) following radical prostatectomy or
Show all 13Show fewer
- Must have had an undetectable PSA after prostatectomy and has since had a rise in post-operative PSA to 0.2 ng/mL or greater
- Zubrod performance status of 0 -1
- No distant metastases, based on the following workup within 60 days prior to registration
- Magnetic resonance imaging (MRI) of the pelvis
- Bone scan or sodium fluoride positron emission tomography (PET), that if suspicious has MRI or plain X-rays to rule out bone metastasis
- Patients can be on androgen deprivation therapy
- Ability to understand and willingness to sign a study-specific informed consent prior to study entry
Who cannot join
- N1 patients are ineligible, as are those with lymph node (LN) enlargement > 1.5 cm by computed tomography (CT) or MRI of the pelvis, unless the LN is biopsy proven to be negative
- Gross residual disease in the prostate fossa appreciated wither on digital rectal examination (DRE) or on imaging, unless biopsy proven not to contain cancer
- Patients who were exposed to neoadjuvant chemotherapy or chemotherapy after prostatectomy
- Prior radiation of any kind to the prostate gland or pelvis
- Prior brachytherapy is not allowed
- History of inflammatory colitis or other active severe comorbidities
- Patients who are on immunosuppressant medication
Trial locations and contacts
1 site in 1 country.
United States1 site
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
About this study
Official title: Phase I Dose-Escalation Study of Hypofractionated SBRT for Adjuvant/Salvage Radiotherapy in Prostate Cancer
This phase I trial studies the side effects and the best dose of hypofractionated stereotactic body radiation therapy (SBRT) in treating patients with prostate cancer that was removed by surgery. Hypofractionated SBRT delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and may have fewer side effects than standard radiation therapy.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine maximum tolerated dose-per-fraction for SBRT to the prostate fossa following prostatectomy based on acute toxicity (< 90 days).
SECONDARY OBJECTIVES:
- To describe the acute (< 90 days) toxicities and adverse events associated with hypofractionated SBRT when administered to the prostate bed in the post-prostatectomy setting.
II. To describe the late (> 90 days from treatment) toxicities and adverse events associated with hypofractionated SBRT when administered to the prostate bed in the post-prostatectomy setting.
TERTIARY OBJECTIVES:
- To describe the patient-reported toxicity/quality of life (QOL) following hypofractionated SBRT treatment.
OUTLINE: This is a dose-escalation study.
Patients undergo 5, 10, or 15 fractions of hypofractionated SBRT daily over 1-3 weeks.
After completion of study treatment, patients are followed up at 2, 6, and 13 weeks and then at 6, 9, 12, 18, 24, 30 and 36 months.
- Conditions
- Stage II Prostate Adenocarcinoma, Stage IIB Prostate Cancer, Stage III Prostate Adenocarcinoma
- Being tested
- Laboratory Biomarker Analysis, Quality-of-Life Assessment, Stereotactic Body Radiation Therapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory Biomarker AnalysisOther
Correlative studies
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Stereotactic Body Radiation TherapyRadiation
Also called SBRT
Undergo hypofractionated SBRT
| Study group | Role | What they receive |
|---|---|---|
| Treatment (hypofractionated SBRT) | Experimental | Patients undergo 5, 10, or 15 fractions of hypofractionated SBRT daily over 1-3 weeks. Receives: Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment; Radiation: Stereotactic Body Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose-per-fraction based on acute toxicity assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 4.03
Maximum tolerated dose (MTD) is defined as the highest dose tested in which none or only one patient experienced dose limiting toxicity (DLT) attributable to the radiation therapy when 12 patients were treated at that dose and are evaluable for toxicity and is one dose level below the lowest dose level tested where two or more patients experienced radiation associated DLT. All toxicities and side effects of all patients who start SBRT will be recorded and summarized.
Measured: < 90 days
Secondary outcomes (1)
Incidence of adverse events assessed according to CTCAE v. 4.03
All toxicities and side effects of all patients who start SBRT will be recorded and summarized.
Measured: Up to 36 months after completion of SBRT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2015 (estimated)
- Study start12 May 2015
- Primary completion26 Feb 2020
- Study completion12 Feb 2023 (estimated)
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 Stage II Prostate AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Leslie Ballas, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02446366
- Sponsor's protocol ID
- 4P-14-8
- Other IDs
- NCI-2015-00296, 4P-14-8, P30CA014089
- Status last verified
- Dec 2022
- First submitted
- 10 Apr 2015
- Last updated
- 12 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Ballas LK, Luo C, Chung E, Kishan AU, Shuryak I, Quinn DI, Dorff T, Jhimlee S, Chiu R, Abreu A, Jennelle R, Aron M, Groshen S. Phase 1 Trial of SBRT to the Prostate Fossa After Prostatectomy. Int J Radiat Oncol Biol Phys. 2019 May 1;104(1):50-60. doi: 10.1016/j.ijrobp.2018.12.047. Epub 2018 Dec 31.
PubMed 30605751
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Dose-Escalation Study of Hypofractionated SBRT for Adjuvant/Salvage Radiotherapy in Prostate Cancer
- ClinicalTrials.gov ID
- NCT02446366
- Acronym / sponsor ID
- 4P-14-8
- Conditions
- Stage II Prostate Adenocarcinoma, Stage IIB Prostate Cancer, Stage III Prostate Adenocarcinoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 12 May 2015 (actual)
- Primary completion
- 26 Feb 2020 (actual)
- Study completion
- 12 Feb 2023 (estimated)
- First posted
- 18 May 2015 (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.
This phase I trial studies the side effects and the best dose of hypofractionated stereotactic body radiation therapy (SBRT) in treating patients with prostate cancer that was removed by surgery. Hypofractionated SBRT delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and may have fewer side effects than standard radiation therapy.
Detailed description
PRIMARY OBJECTIVES:
- To determine maximum tolerated dose-per-fraction for SBRT to the prostate fossa following prostatectomy based on acute toxicity (< 90 days).
SECONDARY OBJECTIVES:
- To describe the acute (< 90 days) toxicities and adverse events associated with hypofractionated SBRT when administered to the prostate bed in the post-prostatectomy setting.
II. To describe the late (> 90 days from treatment) toxicities and adverse events associated with hypofractionated SBRT when administered to the prostate bed in the post-prostatectomy setting.
TERTIARY OBJECTIVES:
- To describe the patient-reported toxicity/quality of life (QOL) following hypofractionated SBRT treatment.
OUTLINE: This is a dose-escalation study.
Patients undergo 5, 10, or 15 fractions of hypofractionated SBRT daily over 1-3 weeks.
After completion of study treatment, patients are followed up at 2, 6, and 13 weeks and then at 6, 9, 12, 18, 24, 30 and 36 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (hypofractionated SBRT) | Experimental | Other: Laboratory Biomarker Analysis, Other: Quality-of-Life Assessment, Radiation: Stereotactic Body Radiation TherapyPatients undergo 5, 10, or 15 fractions of hypofractionated SBRT daily over 1-3 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Adenocarcinoma of the prostate treated primarily with radical prostatectomy
- One of the following pathologic classifications
- Zubrod performance status of 0 -1
- No distant metastases, based on the following workup within 60 days prior to registration
- Patients can be on androgen deprivation therapy
Key exclusion criteria (7 listed)
- N1 patients are ineligible, as are those with lymph node (LN) enlargement > 1.5 cm by computed tomography (CT) or MRI of the pelvis, unless the LN is biopsy proven to be negative
- Gross residual disease in the prostate fossa appreciated wither on digital rectal examination (DRE) or on imaging, unless biopsy proven not to contain cancer
- Patients who were exposed to neoadjuvant chemotherapy or chemotherapy after prostatectomy
- Prior radiation of any kind to the prostate gland or pelvis
- History of inflammatory colitis or other active severe comorbidities
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 |
|---|---|---|
| Laboratory Biomarker AnalysisCorrelative studies | Other | Treatment (hypofractionated SBRT) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Treatment (hypofractionated SBRT) |
| Stereotactic Body Radiation TherapyAlso: SBRTUndergo hypofractionated SBRT | Radiation | Treatment (hypofractionated SBRT) |
Primary outcome
Maximum tolerated dose-per-fraction based on acute toxicity assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 4.03
Time frame: < 90 days
Maximum tolerated dose (MTD) is defined as the highest dose tested in which none or only one patient experienced dose limiting toxicity (DLT) attributable to the radiation therapy when 12 patients were treated at that dose and are evaluable for toxicity and is one dose level below the lowest dose level tested where two or more patients experienced radiation associated DLT. All toxicities and side effects of all patients who start SBRT will be recorded and summarized.
1 secondary outcome
Incidence of adverse events assessed according to CTCAE v. 4.03
Time frame: Up to 36 months after completion of SBRT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2022.
- Derived from this study: PubMed 30605751Ballas LK, Luo C, Chung E, Kishan AU, Shuryak I, Quinn DI, Dorff T, Jhimlee S, Chiu R, Abreu A, Jennelle R, Aron M, Groshen S. Phase 1 Trial of SBRT to the Prostate Fossa After Prostatectomy. Int J Radiat Oncol Biol Phys. 2019 May 1;104(1):50-60. doi: 10.1016/j.ijrobp.2018.12.047. Epub 2018 Dec 31.
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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.
Leslie Ballas principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laboratory Biomarker Analysis, Quality-of-Life Assessment and Stereotactic Body Radiation Therapy in people with Stage II Prostate Adenocarcinoma and Stage IIB Prostate Cancer, run by University of Southern California 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 13 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 12 Dec 2022. 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.
Are results available for this study?
Results are not available in the source record.
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-per-fraction based on acute toxicity assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 4.03 (time frame: < 90 days). 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 NCT02446366, 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 12 Dec 2022.