Metastatic Castrate-resistant Prostate CancerPhase 2NCT01818986
Sipuleucel-T and Stereotactic Ablative Body Radiation (SABR) for Metastatic Castrate-resistant Prostate Cancer (mCRPC)
A Phase 2 study testing Sipuleucel-T and Stereotactic Ablative Body Radiation in people with Metastatic Castrate-resistant Prostate Cancer and mCRPC, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
In this i-SABR (immunotherapy + Stereotactic Ablative Body Radiation) trial, the stereotactic radiation to multiple metastatic sites is delivered not only to eradicate sites of bulky progressive disease, but also to provide antigen presentation and immune stimulation which is expected to act synergistically to the… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Metastatic Castrate-resistant Prostate Cancer, mCRPC
- What is being tested?
- Sipuleucel-T and Stereotactic Ablative Body Radiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jul 2013to 25 May 2021
- Phase
- Phase 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biopsy proven prostate cancer
- Patient must currently be on androgen deprivation or anti-androgen therapy with castrate levels of testosterone (< 50ng/dl). Medical castration should continue until disease progression
- Radiographic evidence of metastatic disease documented with bone scan or CT scan. Patients with any number of metastatic site are allowed to enroll. However, only up to six sites will be selected for SBRT treatment, at the discretion of the treating radiation oncologist.
- PSA ≥ 5 ng/ml
- Asymptomatic or minimally symptomatic patients1. Visual Analog Scale (VAS) ≤ 4;vNo narcotic use in the last 21 days
- Adequate hematologic, renal, and liver function
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- Previous treatment with surgery, radiation or hormonal therapy is allowed.
- Performance status ECOG 0 or 1.
- Life expectancy of at least 6 months
- Negative serology tests for human immunodeficiency virus (HIV) 1 and 2, human T cell lymphotropic virus (HTLV)-1, Hepatitis B and C.
- Age ≥ 18 years.
- Ability to understand and the willingness to sign a written informed consent
Who cannot join
- Subjects must not have had more than two different regiments of chemotherapy previously or any chemotherapy within the past three months.
- Subjects may not be receiving any other investigational agents for the treatment of prostate cancer.
- Subjects with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- Subjects with malignant pleural effusions and malignant ascites
- Systemic corticosteroid use within past 28 days. Use of inhaled, intranasal, and topical steroids is acceptable.
- Systemic immunosuppressive therapy in the past 28 days.
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- Use of any of the following within the past 28 days: Megestrol acetate (Megace®), diethyl stilbestrol (DES), or cyproterone acetate, Ketoconazole, high dose calcitriol [1,25(OH)2VitD] (i.e., > 7.0 μg/week).
- Inability to tolerate contrast dye for baseline CT imaging.
- Initiation or discontinuation of biphosphonate use within past 28 days.
- Subjects with pathologic long-bone fractures
- Subjects with spinal cord compression
- Paget's disease of bone.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
About this study
Official title: Phase II Trial of Sipuleucel-T and Stereotactic Ablative Body Radiation (SABR) for Patients With Metastatic Castrate-resistant Prostate Cancer (mCRPC)
In this i-SABR (immunotherapy + Stereotactic Ablative Body Radiation) trial, the stereotactic radiation to multiple metastatic sites is delivered not only to eradicate sites of bulky progressive disease, but also to provide antigen presentation and immune stimulation which is expected to act synergistically to the concurrently administered immunotherapy Sipuleucel-T and thereby significantly improve the treatment outcome for metastatic castrate resistant prostate cancer patients (mCRPC). Both Sipuleucel-T and SABR are FDA approved therapeutic cancer treatment
- Being tested
- Sipuleucel-T, Stereotactic Ablative Body Radiation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sipuleucel-TDrug
Also called Provenge
Stereotactic Ablative Body RadiationRadiation
Also called SABR
| Study group | Role | What they receive |
|---|---|---|
| arm one | Experimental | Sipuleucel-T and Stereotactic Ablative Body Radiation (SABR) Receives: Drug: Sipuleucel-T; Radiation: Stereotactic Ablative Body Radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Progression
To evaluate the improvement in the time to progression (TTP) of metastatic prostate cancer after the combined treatment with sipuleucel-T and SABR to metastatic sites, as compared to the historically reported data with the treatment of sipuleucel-T alone. Progression will be evaluated in this study using the modified new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) Committee [JNCI 92(3):205-216, 2000] with modifications suggested by PCWG2 [49] recommendations and as used in the Phase III clinical trial by Kantoff et. al.[10]. Changes in only the largest diameter (one-dimensional measurement) of the tumor lesions are used in the RECIST v1.1 criteria as outlined in http://www.recist.com/.
Measured: 4 years
Secondary outcomes (7)
Immune Response
To evaluate the percentage of participants with Immune response at 6 weeks. Immune response will be measured using ELISpot assay (with PA2024). An immune endpoint will be reached by the patient if a >100% increase in immune response is measured by ANY of the assays.
Measured: 6 week
Overall Survival (OS)
To evaluate the improvement in the overall survival (OS) of mCRPCa patients after the combined treatment with sipuleucel-T and SABR to metastatic sites, as compared to the historically reported data with the treatment of sipuleucel-T alone. Overall survival (OS) was defined as the duration of time from the start of treatment to the time of death from any cause.
Measured: 60 months
Progression Free Survival (PFS)
To evaluate the improvement in the progression free survival (PFS) of mCRPCa patients after the combined treatment with sipuleucel-T and SABR to metastatic sites, as compared to the historically reported data with the treatment of sipuleucel-T alone. Progression free survival (PFS) was defined as the length of time from the start of treatment to disease progression or death from any cause.
Measured: 4 years
Biochemical Progression Free Survival (bPFS)
To evaluate the improvement in the biochemical progression free survival (bPFS) of mCRPCa patients after the combined treatment with sipuleucel-T and SABR to metastatic sites, as compared to the historically reported data with the treatment of sipuleucel-T alone. Biochemical progression free survival was defined as the time from the beginning of treatment to PSA (prostate-specific antigen) disease progression. Biochemical progression was defined as an increase in PSA of > 2 ng/ml from baseline and an increase of > 25% from the baseline value and confirmed by a second measurement more than three weeks later.
Measured: 4 years
Prostate Cancer-specific Survival (PCaSS)
To evaluate the improvement in the prostate cancer-specific survival (PCaSS) of mCRPCa patients after the combined treatment with sipuleucel-T and SABR to metastatic sites, as compared to the historically reported data with the treatment of sipuleucel-T alone. Prostate cancer-specific survival was defined as the percentage of patients who had not died from prostate cancer at the time of analysis
Measured: 4 years
Adverse Events
To evaluate the adverse events for the first 6 months after completion of radiation therapy associated with Sipuleucel-T when administered in combination with SABR to metastatic sites, as compared to the historically reported data with the treatment of Sipuleucel-T alone. Toxicity will be assessed according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE), version 4.0. Adverse events not specifically defined in the NCI CTCAE will be scored on the Adverse Event log according to the general guidelines provided by the NCI CTCAE and as outlined:
Grade 1: Mild Grade 2: Moderate Grade 3: Severe or medically significant but not immediately life threatening Grade 4: Life threatening consequences Grade 5: Death related to the adverse event
Measured: 60 months
Cost Effectiveness and Health-related Quality Adjusted Life
To evaluate the cost effectiveness and health-related quality adjusted life of the combination treatment of SABR and sipuleucel T in patients with mCRPC.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2013 (estimated)
- Study start10 Jul 2013
- Primary completion20 Dec 2019
- Study completion25 May 2021
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 Metastatic Castrate-resistant Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raquibul Hannan, University of Texas Southwestern Medical Center
- Investigators
- Raquibul Hannan, MD, PhD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01818986
- Sponsor's protocol ID
- STU 102012-026
- Status last verified
- Apr 2022
- First submitted
- 6 Mar 2013
- Last updated
- 6 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Sipuleucel-T and Stereotactic Ablative Body Radiation (SABR) for Patients With Metastatic Castrate-resistant Prostate Cancer (mCRPC)
- ClinicalTrials.gov ID
- NCT01818986
- Acronym / sponsor ID
- STU 102012-026
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 10 Jul 2013 (actual)
- Primary completion
- 20 Dec 2019 (actual)
- Study completion
- 25 May 2021 (actual)
- First posted
- 27 Mar 2013 (estimated)
- Results
- Posted 6 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this i-SABR (immunotherapy + Stereotactic Ablative Body Radiation) trial, the stereotactic radiation to multiple metastatic sites is delivered not only to eradicate sites of bulky progressive disease, but also to provide antigen presentation and immune stimulation which is expected to act synergistically to the concurrently administered immunotherapy Sipuleucel-T and thereby significantly improve the treatment outcome for metastatic castrate resistant prostate cancer patients (mCRPC). Both Sipuleucel-T and SABR are FDA approved therapeutic cancer treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| arm one | Experimental | Drug: Sipuleucel-T, Radiation: Stereotactic Ablative Body RadiationSipuleucel-T and Stereotactic Ablative Body Radiation (SABR) |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Biopsy proven prostate cancer
- Patient must currently be on androgen deprivation or anti-androgen therapy with castrate levels of testosterone (< 50ng/dl). Medical castration should continue until disease progression
- Radiographic evidence of metastatic disease documented with bone scan or CT scan. Patients with any number of metastatic site are allowed to enroll. However, only up to six sites will be selected for SBRT treatment, at the discretion of the treating radiation oncologist.
- PSA ≥ 5 ng/ml
- Asymptomatic or minimally symptomatic patients1. Visual Analog Scale (VAS) ≤ 4;vNo narcotic use in the last 21 days
Key exclusion criteria (13 listed)
- Subjects must not have had more than two different regiments of chemotherapy previously or any chemotherapy within the past three months.
- Subjects may not be receiving any other investigational agents for the treatment of prostate cancer.
- Subjects with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- Subjects with malignant pleural effusions and malignant ascites
- Systemic corticosteroid use within past 28 days. Use of inhaled, intranasal, and topical steroids is acceptable.
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 |
|---|---|---|
| Sipuleucel-TAlso: Provenge | Drug | arm one |
| Stereotactic Ablative Body RadiationAlso: SABR | Radiation | arm one |
Primary outcome
Time to Progression
Time frame: 4 years
To evaluate the improvement in the time to progression (TTP) of metastatic prostate cancer after the combined treatment with sipuleucel-T and SABR to metastatic sites, as compared to the historically reported data with the treatment of sipuleucel-T alone. Progression will be evaluated in this study using the modified new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) Committee [JNCI 92(3):205-216, 2000] with modifications suggested by PCWG2 [49] recommendations and as used in the Phase III clinical trial by Kantoff et. al.[10]. Changes in only the largest diameter (one-dimensional measurement) of the tumor lesions are used in the RECIST v1.1 criteria as outlined in http://www.recist.com/.
7 secondary outcomes
Immune Response
Time frame: 6 week
Overall Survival (OS)
Time frame: 60 months
Progression Free Survival (PFS)
Time frame: 4 years
Biochemical Progression Free Survival (bPFS)
Time frame: 4 years
Prostate Cancer-specific Survival (PCaSS)
Time frame: 4 years
Adverse Events
Time frame: 60 months
Cost Effectiveness and Health-related Quality Adjusted Life
Time frame: 4 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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RecruitingPhase 2
A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer
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ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
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FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
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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.
Raquibul Hannan, MD, PhD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sipuleucel-T and Stereotactic Ablative Body Radiation in people with Metastatic Castrate-resistant Prostate Cancer and mCRPC, run by University of Texas Southwestern Medical 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 12 inclusion and 13 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 May 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.
What does this phase mean?
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 6 May 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?
Time to Progression (time frame: 4 years). 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 May 2022.