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Sipuleucel-T and Stereotactic Ablative Body Radiation (SABR) for Metastatic Castrate-resistant Prostate Cancer (mCRPC) | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Sipuleucel-T and Stereotactic Ablative Body Radiation (SABR) for Metastatic Castrate-resistant Prostate Cancer (mCRPC)

Phase II Trial of Sipuleucel-T and Stereotactic Ablative Body Radiation (SABR) for Patients With Metastatic Castrate-resistant Prostate Cancer (mCRPC)

NCT01818986•University of Texas Southwestern Medical Center

View on ClinicalTrials.gov

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 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

Eligibility

Age

18 - 99 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Biopsy proven prostate cancer
•2. 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
•3. 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.
•4. PSA ≥ 5 ng/ml
•5. Asymptomatic or minimally symptomatic patients1. Visual Analog Scale (VAS) ≤ 4;vNo narcotic use in the last 21 days
•6. Adequate hematologic, renal, and liver function
•7. Previous treatment with surgery, radiation or hormonal therapy is allowed.
•8. Performance status ECOG 0 or 1.
•9. Life expectancy of at least 6 months
•10. Negative serology tests for human immunodeficiency virus (HIV) 1 and 2, human T cell lymphotropic virus (HTLV)-1, Hepatitis B and C.
+2 more criteria

Exclusion Criteria

•1. Subjects must not have had more than two different regiments of chemotherapy previously or any chemotherapy within the past three months.
•2. Subjects may not be receiving any other investigational agents for the treatment of prostate cancer.
•3. 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.
•4. Subjects with malignant pleural effusions and malignant ascites
•5. Systemic corticosteroid use within past 28 days. Use of inhaled, intranasal, and topical steroids is acceptable.
•6. Systemic immunosuppressive therapy in the past 28 days.
•7. 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).
•8. Inability to tolerate contrast dye for baseline CT imaging.
•9. Initiation or discontinuation of biphosphonate use within past 28 days.
•10. Subjects with pathologic long-bone fractures
+3 more criteria

Locations (1)

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Key Dates

Start Date

July 10, 2013

Primary Completion Date

December 20, 2019

Completion Date

May 25, 2021

Last Updated

May 6, 2022

Enrollment

ACTUAL participants

Conditions

Metastatic Castrate-resistant Prostate CancermCRPC

Interventions

Sipuleucel-T

DRUG

Stereotactic Ablative Body Radiation

RADIATION

AB-3028, a Programmable Circuit T Cell Therapy in Patients With Castration Resistant Prostate Cancer (CRPC)

NCT07285694

Metastatic Castration Resistant Prostate Cancer (mCRPC)

View study

RECRUITINGPHASE1

A Clinical Study of KTX-2001 in Subjects With Metastatic Castration-Resistant Prostate Cancer (STRIKE-001)

NCT07103018

Metastatic Castration-resistant Prostate CancerMetastatic Castration-Resistant Prostate Cancer Patients+3 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 6, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Sipuleucel-T and Stereotactic Ablative Body Radiation (SABR) for Metastatic Castrate-resistant Prostate Cancer (mCRPC)

Inclusion Criteria

Exclusion Criteria

AB-3028, a Programmable Circuit T Cell Therapy in Patients With Castration Resistant Prostate Cancer (CRPC)

A Clinical Study of KTX-2001 in Subjects With Metastatic Castration-Resistant Prostate Cancer (STRIKE-001)

SHR-1701 in Combination With Stereotactic Body Radiotherapy in mCRPC

Study of Alpha Radioligand Therapy AB001 in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)

Study to Assess Safety, Tolerability and Activity of DSB2455 in Participants With Advanced Malignancies

Four-Timepoint Multi-tracer PET Imaging to Characterize Metastatic prOstate Cancer Heterogeneity