A Phase 2 interventional study of sipuleucel-T and external beam radiation therapy in Adenocarcinoma of the Prostate, Bone Metastases and Hormone-resistant Prostate Cancer, sponsored by City of Hope Medical Center. Completed at 3 sites in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by City of Hope Medical Center · Phase 2, Interventional, and Treatment
This randomized phase II trial studies how well giving sipuleucel-T with or without radiation therapy works in treating patients with hormone-resistant metastatic prostate cancer. Vaccines may help the body build an effective immune response to kill tumor cells. Radiation therapy uses high energy x rays to kill tumor cells. It is not yet known whether giving sipuleucel-T vaccine is more effective with or without radiation therapy in treating prostate cancer
PRIMARY OBJECTIVES:
I. To assess the feasibility, based on percent able or willing to receive all three infusions of sipuleucel-T immunotherapy, when combining sipuleucel-T with radiation therapy to a single site of metastasis delivered one week prior to beginning of sipuleucel-T therapy.
SECONDARY OBJECTIVES:
I. To assess the effect of radiation therapy to single metastasis on immune response (antibody and T-cell proliferation to prostate acid phosphate [PAP] and fusion protein PA2024) generated by sipuleucel-T immunotherapy.
II. To assess the effect of external beam radiotherapy to single metastasis on prostate specific antigen (PSA) response to therapy with sipuleucel-T.
III. To assess the effect of external beam radiotherapy to single metastasis on radiographic response rate to therapy with sipuleucel-T.
IV. To assess the time from the onset of therapy with sipuleucel-T +/- radiation to the need for subsequent therapy for prostate cancer.
V. To assess the toxicity associated with sipuleucel-T +/- radiation.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM A: Patients receive sipuleucel-T intravenously (IV) over 60 minutes days 22, 36, and 50.
ARM B: Patients undergo external beam radiation therapy in weeks 1-2. Patients also receive sipuleucel-T as in Arm A.
In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up until week 60.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 51 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →City of Hope Medical Center is the lead sponsor of 670 studies on the registry; 181 are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 12 (40%) have results posted.
Counted across the registry records on this site, refreshed daily.
Castration resistant prostatic adenocarcinoma; subjects must have current or historical evidence of disease progression despite castrated level of testosterone (\< 50 ng/dL) achieved by orchiectomy or luteinizing hormone-releasing hormone (LHRH) agonist or antagonist therapy; disease progression has to be demonstrated by PSA progression OR progression of measurable disease OR progression of non-measurable disease as defined below:
Non-measurable disease:
Exclusion Criteria:
Treatment with any of the following medications or interventions within 28 days of registration:
Concurrent other malignancy with the exception of:
Patients receive sipuleucel-T IV over 60 minutes days 22, 36, and 50.
Biological: sipuleucel-T · Other: laboratory biomarker analysis
Patients undergo external beam radiation therapy in weeks 1-2. Patients also receive sipuleucel-T as in Arm A.
Biological: sipuleucel-T · Radiation: external beam radiation therapy · Other: laboratory biomarker analysis
Given IV
Also known as: APC 8015, Provenge
Undergo external beam radiation therapy
Also known as: EBRT
Correlative studies
Progression-free Survival
Estimated using the product-limit method of Kaplan and Meier. Progression is defined as one or more of the following: 20% increase in the sum of the longest diameters of target measurable lesions over the smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline; unequivocal progression of non-measurable disease in the opinion of the treating physician; appearance of any new lesions; PSA increase of 25% from baseline or nadir and by 2ng/uL or greater at 12 weeks; death due to disease without prior documentation of progression and without symptomatic deterioration.
Time frame: Until progression or death, Up to 2 years.
Number of Participants With Grade 2 or Above Adverse Events
Number of participants with specified adverse event that is grade 2 or above and related to treatment. Graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0
Time frame: Up to 60 weeks
| Milestone | Arm A (Sipuleucel-T) | Arm B (Radiation Therapy, Sipuleucel-T) |
|---|---|---|
| Started | 25 | 26 |
| Completed | 24 | 25 |
| Not completed | 1 | 1 |
| Withdrew: Receive no sip-t due to iv access | 1 | 1 |
Estimated using the product-limit method of Kaplan and Meier. Progression is defined as one or more of the following: 20% increase in the sum of the longest diameters of target measurable lesions over the smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline; unequivocal progression of non-measurable disease in the opinion of the treating physician; appearance of any new lesions; PSA increase of 25% from baseline or nadir and by 2ng/uL or greater at 12 weeks; death due to disease without prior documentation of progression and without symptomatic deterioration.
| Months | Arm A (Sipuleucel-T) | Arm B (Radiation Therapy, Sipuleucel-T) |
|---|---|---|
| Progression-free Survival | 2.46 (2.17 to 2.66) | 3.65 (2.76 to 4.86) |
Number of participants with specified adverse event that is grade 2 or above and related to treatment. Graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0
| participants | Arm A (Sipuleucel-T) | Arm B (Radiation Therapy, Sipuleucel-T) |
|---|---|---|
| Grade 2 : Chills | 3 | 0 |
| Grade 2 : Fatigue | 1 | 2 |
| Grade 2 : Infusion Reaction | 1 | 1 |
| Grade 2 : Decreased Lymphocyte Count | 1 | 0 |
| Grade 2 : Nausea | 0 | 1 |
| Grade 2 : Pain in Extremity | 0 | 1 |
| Grade 2 : Anemia | 0 | 1 |
| Grade 2 : Anorexia | 0 | 1 |
| Grade 2 : Headache | 1 | 1 |
| Grade 2 : Hypertension | 0 | 3 |
| Grade 3 : Chills | 0 | 0 |
| Grade 3 : Fatigue | 0 | 0 |
| Grade 3 : Infusion Reaction | 0 | 0 |
| Grade 3 : Decreased Lymphocyte Count | 0 | 0 |
| Grade 3 : Nausea | 0 | 0 |
| Grade 3 : Pain in Extremity | 0 | 0 |
| Grade 3 : Anemia | 0 | 1 |
| Grade 3 : Anorexia | 0 | 0 |
| Grade 3 : Headache | 0 | 0 |
| Grade 3 : Hypertension | 0 | 0 |
Collected over Adverse events were collected over a period of 1 year and 3 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm A (Sipuleucel-T) | 0/25 (0%) | 1/25 (4%) | 25/25 (100%) |
| Arm B (Radiation Therapy, Sipuleucel-T) | 0/24 (0%) | 1/24 (4.2%) | 24/24 (100%) |
| Event | Arm A (Sipuleucel-T) | Arm B (Radiation Therapy, Sipuleucel-T) |
|---|---|---|
| HematuriaRenal and urinary disorders | 0/25 | 1/24 |
| Skin infectionInfections and infestations | 1/25 | 0/24 |
| Event | Arm A (Sipuleucel-T) | Arm B (Radiation Therapy, Sipuleucel-T) |
|---|---|---|
| HypertensionVascular disorders | 11/25 | 12/24 |
| FatigueGeneral disorders and administration site conditions | 12/25 | 10/24 |
| AnemiaBlood and lymphatic system disorders | 7/25 | 11/24 |
| ChillsGeneral disorders and administration site conditions | 9/25 | 2/24 |
| Sinus bradycardiaCardiac disorders | 7/25 | 7/24 |
| NauseaGastrointestinal disorders | 2/25 | 7/24 |
| Alkaline phosphatase increasedInvestigations | 4/25 | 7/24 |
| Platelet count decreasedInvestigations | 3/25 | 7/24 |
| Back painMusculoskeletal and connective tissue disorders | 3/25 | 6/24 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 3/25 | 6/24 |
| Age, Continuous(years) | Arm A (Sipuleucel-T) | Arm B (Radiation Therapy, Sipuleucel-T) | Total |
|---|---|---|---|
| Median | 64 (45 to 90) | 67 (54 to 81) | 67 (45 to 90) |
| Sex: Female, Male(Participants) | Arm A (Sipuleucel-T) | Arm B (Radiation Therapy, Sipuleucel-T) | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 24 | 25 | 49 |
| Race/Ethnicity, Customized(Participants) | Arm A (Sipuleucel-T) | Arm B (Radiation Therapy, Sipuleucel-T) | Total |
|---|---|---|---|
| Caucasian | 20 | 20 | 40 |
| Hispanic | 2 | 2 | 4 |
| Asian | 0 | 2 | 2 |
| African American | 2 | 0 | 2 |
| Not Reported | 0 | 1 | 1 |
| Region of Enrollment(participants) | Arm A (Sipuleucel-T) | Arm B (Radiation Therapy, Sipuleucel-T) | Total |
|---|---|---|---|
| United States | 24 | 25 | 49 |
| Gleason Score(Gleason grading) | Arm A (Sipuleucel-T) | Arm B (Radiation Therapy, Sipuleucel-T) | Total |
|---|---|---|---|
| Median | 8 (6 to 10) | 7 (7 to 9) | 8 (6 to 10) |
Documents are hosted by the registry — open the source record to download them.
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
City of Hope Medical Center