Stage I Prostate Adenocarcinoma American Joint Committee on Cancer (AJCC) v7NCT02830165
Stereotactic Body Radiation Therapy in Treating Patients With High-Risk Prostate Cancer Undergoing Surgery
A study testing Laboratory Biomarker Analysis, Quality-of-Life Assessment and Stereotactic Body Radiation Therapy in people with Stage I Prostate Adenocarcinoma American Joint Committee on Cancer (AJCC) v7 and Stage II Prostate Adenocarcinoma AJCC v7, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial summary
This phase I trial studies stereotactic body radiation therapy (SBRT) in treating patients with prostate cancer that is likely to come back or spread (high-risk) undergoing surgery. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Stage I Prostate Adenocarcinoma American Joint Committee on Cancer (AJCC) v7, Stage II Prostate Adenocarcinoma AJCC v7, Stage III Prostate Adenocarcinoma AJCC v7
- 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
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2016to 27 May 2022
- Phase
- Interventional
- 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 confirmed primary non-metastatic adenocarcinoma of the prostate
- Patient desires and is medically fit to undergo prostatectomy
- Karnofsky performance status (KPS) >= 70
- Patients on androgen deprivation therapy (ADT) are allowed
- For confirmation of high risk local failure status, patients will have any one of the following:
- Computed tomography (CT) or magnetic resonance imaging (MRI) demonstrating seminal vesicle invasion (SVI) or extraprostatic extension (EPE) within 1 year of enrollment into the study
Show all 11Show fewer
- Pre-biopsy prostate-specific antigen (PSA) >= 20
- Gleason score 7-10 (Gleason 7 must be 4+3), presence of any Gleason 5 (even if a tertiary score) as determined at diagnostic biopsy
- Gleason score 7 and > 50% of biopsy cores positive for prostate cancer
- Clinical stage >= T3 (staging by imaging acceptable)
- An image-guided biopsy (via Artemis Ultrasound with MRI co-registration) is encouraged but not required if not performed as standard of care biopsy
Who cannot join
- Distant metastases, based upon:
- CT scan or MRI of the abdomen/pelvis or prostate specific membrane antigen (PSMA) positron emission tomography/computed tomography (PET/CT) within 120 days prior to registration and
- Bone scan or PSMA PET/CT within 120 days prior to registration; if the bone scan is suspicious, a plain x-ray and/or MRI must be obtained to rule out metastasis prior to registration
- Patient is unable or unwilling to sign consent
- Patient is considered low-risk and would not have received adjuvant radiation therapy (RT) outside of this study
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095
About this study
Official title: Phase I Feasibility Trial of Preoperative Adjuvant Stereotactic Body Radiotherapy for Patients at High Risk of Local Failure After Prostatectomy
This phase I trial studies stereotactic body radiation therapy (SBRT) in treating patients with prostate cancer that is likely to come back or spread (high-risk) undergoing surgery. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Delivering radiotherapy before prostatectomy by SBRT is more convenient, conformal, and may spare normal tissues better than delivering radiotherapy after prostatectomy.
Read the detailed description
PRIMARY OBJECTIVES:
- To assess feasibility of pre-operative stereotactic body radiotherapy (SBRT) in prostate cancer patients at high risk for recurrence after prostatectomy.
SECONDARY OBJECTIVES:
- To assess safety and acute toxicity of SBRT followed by prostatectomy. This will be based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 and patient reported quality of life (Expanded Prostate Cancer Index Composite [EPIC] and International Prostate Symptom Score [IPSS] questionnaires).
II. Investigation of the radiobiology of SBRT in prostate cancer using resected prostate tumor tissue.
III. Evaluation of the nature of the immune response to prostate cancer generated by SBRT.
OUTLINE:
Patients undergo 3 fractions of SBRT over 1-2 weeks, 2-4 weeks prior to radical prostatectomy.
After completion of the study treatment, patients are followed up at 0 to 4 weeks, and every 3 months for 1 year.
- Conditions
- Stage I Prostate Adenocarcinoma American Joint Committee on Cancer (AJCC) v7, Stage II Prostate Adenocarcinoma AJCC v7, Stage III Prostate Adenocarcinoma AJCC v7
- Being tested
- Laboratory Biomarker Analysis, Quality-of-Life Assessment, Stereotactic Body Radiation Therapy
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 SABR, SBRT, Stereotactic Ablative Body Radiation Therapy
Undergo SBRT
| Study group | Role | What they receive |
|---|---|---|
| Treatment (SBRT) | Experimental | Patients undergo 3 fractions of SBRT over 1-2 weeks, 2-4 weeks prior to radical prostatectomy. 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.
Number of Participants Who Completed the Maximum Time Allowed on Study Without Severe Acute Surgical Complications
Measured: At 4 weeks post surgery
Secondary outcomes (4)
Number of Participants With Genitourinary Toxicities and Gastrointestinal Toxicities
Based on the Common Terminology Criteria for Adverse Events (CTCAE) v4. Grade refers to the severity of the adverse event. Indications are Grade 1 is Mild, Grade 2 is Moderate, Grade 3 is Severe or medically significant but not immediately life threatening. Grade 0 refers to absence of an adverse event (ae).
Measured: Up to 1 year
Changes in Quality of Life (QOL) ,From Baseline to 12 Months, as Measured on the Expanded Prostate Cancer Index Composite (EPIC-26) Questionnaire Scoring.
The Expanded Prostate Cancer Index Composite Short Form (EPIC-26) is composed of 26 items and measures health-related quality of life across 5 prostate cancer domains. Response options for each EPIC item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing a better quality of life.
Measured: score from baseline to twelve months
Changes in Quality of Life as Measured on the International Prostate Symptom Score (IPSS) Questionnaire.
The International Prostate Symptom Score is composed of seven questions and scored from 0 - 35, with higher scores indicating more severe symptoms.
Measured: Mean change in I-PSS score from baseline to 12 months.
Correlative Biomarker Analyses Using Tissue and Serial Blood Samples
Tissue specimens of the primary tumor as well as blood draws before and after treatment will be used to conduct biomarker and molecular analyses relevant to understanding the biology of prostate SBRT
Measured: Baseline and to up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2016 (estimated)
- Study start15 Jun 2016
- Primary completion9 May 2020
- Study completion27 May 2022
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.
- Other trials for Stage I Prostate Adenocarcinoma American Joint Committee on Cancer (AJCC) v7Studies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe 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
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Nicholas Nickols, MD, PhD, Principal investigator, UCLA / Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02830165
- Sponsor's protocol ID
- 15-001580
- Other IDs
- NCI-2016-00188, JCCCID608, P50CA092131
- Status last verified
- May 2022
- First submitted
- 7 Jul 2016
- Last updated
- 23 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Feasibility Trial of Preoperative Adjuvant Stereotactic Body Radiotherapy for Patients at High Risk of Local Failure After Prostatectomy
- ClinicalTrials.gov ID
- NCT02830165
- Acronym / sponsor ID
- 15-001580
- Conditions
- Stage I Prostate Adenocarcinoma American Joint Committee on Cancer (AJCC) v7, Stage II Prostate Adenocarcinoma AJCC v7, Stage III Prostate Adenocarcinoma AJCC v7
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 15 Jun 2016 (actual)
- Primary completion
- 9 May 2020 (actual)
- Study completion
- 27 May 2022 (actual)
- First posted
- 12 Jul 2016 (estimated)
- Results
- Posted 6 Jan 2022
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 stereotactic body radiation therapy (SBRT) in treating patients with prostate cancer that is likely to come back or spread (high-risk) undergoing surgery. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Delivering radiotherapy before prostatectomy by SBRT is more convenient, conformal, and may spare normal tissues better than delivering radiotherapy after prostatectomy.
Detailed description
PRIMARY OBJECTIVES:
- To assess feasibility of pre-operative stereotactic body radiotherapy (SBRT) in prostate cancer patients at high risk for recurrence after prostatectomy.
SECONDARY OBJECTIVES:
- To assess safety and acute toxicity of SBRT followed by prostatectomy. This will be based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 and patient reported quality of life (Expanded Prostate Cancer Index Composite [EPIC] and International Prostate Symptom Score [IPSS] questionnaires).
II. Investigation of the radiobiology of SBRT in prostate cancer using resected prostate tumor tissue.
III. Evaluation of the nature of the immune response to prostate cancer generated by SBRT.
OUTLINE:
Patients undergo 3 fractions of SBRT over 1-2 weeks, 2-4 weeks prior to radical prostatectomy.
After completion of the study treatment, patients are followed up at 0 to 4 weeks, and every 3 months for 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (SBRT) | Experimental | Other: Laboratory Biomarker Analysis, Other: Quality-of-Life Assessment, Radiation: Stereotactic Body Radiation TherapyPatients undergo 3 fractions of SBRT over 1-2 weeks, 2-4 weeks prior to radical prostatectomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histologically confirmed primary non-metastatic adenocarcinoma of the prostate
- Patient desires and is medically fit to undergo prostatectomy
- Karnofsky performance status (KPS) >= 70
- Patients on androgen deprivation therapy (ADT) are allowed
- For confirmation of high risk local failure status, patients will have any one of the following:
Key exclusion criteria (5 listed)
- Distant metastases, based upon:
- Patient is unable or unwilling to sign consent
- Patient is considered low-risk and would not have received adjuvant radiation therapy (RT) outside of this study
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 (SBRT) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Treatment (SBRT) |
| Stereotactic Body Radiation TherapyAlso: SABR, SBRT, Stereotactic Ablative Body Radiation TherapyUndergo SBRT | Radiation | Treatment (SBRT) |
Primary outcome
Number of Participants Who Completed the Maximum Time Allowed on Study Without Severe Acute Surgical Complications
Time frame: At 4 weeks post surgery
4 secondary outcomes
Number of Participants With Genitourinary Toxicities and Gastrointestinal Toxicities
Time frame: Up to 1 year
Changes in Quality of Life (QOL) ,From Baseline to 12 Months, as Measured on the Expanded Prostate Cancer Index Composite (EPIC-26) Questionnaire Scoring.
Time frame: score from baseline to twelve months
Changes in Quality of Life as Measured on the International Prostate Symptom Score (IPSS) Questionnaire.
Time frame: Mean change in I-PSS score from baseline to 12 months.
Correlative Biomarker Analyses Using Tissue and Serial Blood Samples
Time frame: Baseline and to up to 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Nicholas Nickols, MD, PhD principal investigator
UCLA / Jonsson Comprehensive Cancer Center
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 I Prostate Adenocarcinoma American Joint Committee on Cancer (AJCC) v7 and Stage II Prostate Adenocarcinoma AJCC v7, run by Jonsson Comprehensive Cancer Center 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 11 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 23 May 2024. 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?
Yes. Results are posted in the registry (first posted 6 Jan 2022). 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 Completed the Maximum Time Allowed on Study Without Severe Acute Surgical Complications (time frame: At 4 weeks post surgery). 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 23 May 2024.