Sipuleucel-T With or Without Radiation Therapy in Treating Patients With Hormone-Resistant Metastatic Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT01807065|
Recruitment Status : Completed
First Posted : March 8, 2013
Results First Posted : August 25, 2020
Last Update Posted : August 25, 2020
|Condition or disease||Intervention/treatment||Phase|
|Adenocarcinoma of the Prostate Bone Metastases Hormone-resistant Prostate Cancer Recurrent Prostate Cancer Soft Tissue Metastases Stage IV Prostate Cancer||Biological: sipuleucel-T Radiation: external beam radiation therapy Other: laboratory biomarker analysis||Phase 2|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||51 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Phase II Trial of Sipuleucel T Immunotherapy Preceded by Sensitizing Radiation Therapy and Sipuleucel-T Alone in Patients With Castrate Resistant Metastatic Prostate Cancer|
|Study Start Date :||June 7, 2013|
|Actual Primary Completion Date :||December 31, 2018|
|Actual Study Completion Date :||December 31, 2019|
Experimental: Arm A (sipuleucel-T)
Patients receive sipuleucel-T IV over 60 minutes days 22, 36, and 50.
Other: laboratory biomarker analysis
Experimental: Arm B (radiation therapy, sipuleucel-T)
Patients undergo external beam radiation therapy in weeks 1-2. Patients also receive sipuleucel-T as in Arm A.
Radiation: external beam radiation therapy
Undergo external beam radiation therapy
Other Name: EBRT
Other: laboratory biomarker analysis
- Progression-free Survival [ Time Frame: Until progression or death, Up to 2 years. ]
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.
- Number of Participants With Grade 2 or Above Adverse Events [ Time Frame: Up to 60 weeks ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01807065
|United States, California|
|City of Hope Medical Center|
|Duarte, California, United States, 91010|
|South Pasadena Cancer Center|
|Pasadena, California, United States, 91030|
|United States, Utah|
|Huntsman Cancer Institute, Univ. of Utah|
|Salt Lake City, Utah, United States, 84112|
|Principal Investigator:||Cy Stein, MD, PhD||City of Hope Medical Center|