Trial · NCT01807065
Sipuleucel-T With or Without Radiation Therapy in Treating Patients With Hormone-Resistant Metastatic Prostate Cancer
NCT01807065, Phase 2, Completed, City of Hope Medical Center; results first posted 2020-08-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Sipuleucel-T With or Without Radiation Therapy in Treating Patients With Hormone-Resistant Metastatic Prostate Cancer. Trials, record NCT01807065. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01807065
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Sipuleucel-T With or Without Radiation Therapy in Treating Patients With Hormone-Resistant Metastatic Prostate Cancer
- NCT number
- NCT01807065
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 51 participants, actual
- Lead sponsor
- City of Hope Medical Center
- Conditions
- Adenocarcinoma of the Prostate, Bone Metastases, Hormone-resistant Prostate Cancer, Recurrent Prostate Cancer, Soft Tissue Metastases, Stage IV Prostate Cancer
- Interventions
- sipuleucel-T, external beam radiation therapy, laboratory biomarker analysis
- First posted
- 2013-03-08
- Last updated
- 2026-09-11
- Results first posted
- 2020-08-25
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival | 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. |
| Secondary | Number of Participants With Grade 2 or Above Adverse Events | 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 |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival | Until progression or death, Up to 2 years. | Months | MEDIAN | |
| SECONDARY | Number of Participants With Grade 2 or Above Adverse Events | Up to 60 weeks | participants | NUMBER |
Source ClinicalTrials.gov
Results by group42
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival | Arm A (Sipuleucel-T) | 2.46 | 95% Confidence Interval 2.17 to 2.66 | Months | |
| Progression-free Survival | Arm B (Radiation Therapy, Sipuleucel-T) | 3.65 | 95% Confidence Interval 2.76 to 4.86 | Months | |
| Number of Participants With Grade 2 or Above Adverse Events | Arm A (Sipuleucel-T) | Grade 2 : Chills | 3 | participants | |
| Number of Participants With Grade 2 or Above Adverse Events | Arm B (Radiation Therapy, Sipuleucel-T) | Grade 2 : Chills | 0 | participants | |
| Number of Participants With Grade 2 or Above Adverse Events | Arm A (Sipuleucel-T) | Grade 2 : Fatigue | 1 | participants | |
| Number of Participants With Grade 2 or Above Adverse Events | Arm B (Radiation Therapy, Sipuleucel-T) | Grade 2 : Fatigue | 2 | participants | |
| Number of Participants With Grade 2 or Above Adverse Events | Arm A (Sipuleucel-T) | Grade 2 : Infusion Reaction | 1 | participants | |
| Number of Participants With Grade 2 or Above Adverse Events | Arm B (Radiation Therapy, Sipuleucel-T) | Grade 2 : Infusion Reaction | 1 | participants | |
| Number of Participants With Grade 2 or Above Adverse Events | Arm A (Sipuleucel-T) | Grade 2 : Decreased Lymphocyte Count | 1 | participants | |
| Number of Participants With Grade 2 or Above Adverse Events | Arm B (Radiation Therapy, Sipuleucel-T) | Grade 2 : Decreased Lymphocyte Count | 0 | participants |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A (Sipuleucel-T) | 25 | |
| Overall Study | STARTED | Arm B (Radiation Therapy, Sipuleucel-T) | 26 | |
| Overall Study | COMPLETED | Arm A (Sipuleucel-T) | 24 | |
| Overall Study | COMPLETED | Arm B (Radiation Therapy, Sipuleucel-T) | 25 | |
| Overall Study | NOT COMPLETED | Arm A (Sipuleucel-T) | 1 | |
| Overall Study | NOT COMPLETED | Arm B (Radiation Therapy, Sipuleucel-T) | 1 |
Source ClinicalTrials.gov
Adverse events196
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Arm A (Sipuleucel-T) | 7 | 25 | 20 |
| other | Anemia | Blood and lymphatic system disorders | Arm B (Radiation Therapy, Sipuleucel-T) | 11 | 24 | 34 |
| other | Leukocytosis | Blood and lymphatic system disorders | Arm A (Sipuleucel-T) | 0 | 25 | 0 |
| other | Leukocytosis | Blood and lymphatic system disorders | Arm B (Radiation Therapy, Sipuleucel-T) | 1 | 24 | 3 |
| other | Sinus bradycardia | Cardiac disorders | Arm A (Sipuleucel-T) | 7 | 25 | 19 |
| other | Sinus bradycardia | Cardiac disorders | Arm B (Radiation Therapy, Sipuleucel-T) | 7 | 24 | 18 |
| other | Sinus tachycardia | Cardiac disorders | Arm A (Sipuleucel-T) | 3 | 25 | 3 |
| other | Sinus tachycardia | Cardiac disorders | Arm B (Radiation Therapy, Sipuleucel-T) | 0 | 24 | 0 |
| other | Watering eyes | Eye disorders | Arm A (Sipuleucel-T) | 1 | 25 | 1 |
| other | Watering eyes | Eye disorders | Arm B (Radiation Therapy, Sipuleucel-T) | 0 | 24 | 0 |
1 to 10 of 196Source ClinicalTrials.gov
See all 196 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A (Sipuleucel-T) | 0 | 25 |
| Total, all-cause mortality | Arm B (Radiation Therapy, Sipuleucel-T) | 0 | 24 |
| Total, other adverse events | Arm A (Sipuleucel-T) | 25 | 25 |
| Total, other adverse events | Arm B (Radiation Therapy, Sipuleucel-T) | 24 | 24 |
| Total, serious adverse events | Arm A (Sipuleucel-T) | 1 | 25 |
| Total, serious adverse events | Arm B (Radiation Therapy, Sipuleucel-T) | 1 | 24 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30682445 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm A (Sipuleucel-T) vs Arm B (Radiation Therapy, Sipuleucel-T): deaths from any cause | Trial comparisons |
| Arm A (Sipuleucel-T) vs Arm B (Radiation Therapy, Sipuleucel-T): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01807065
GET https://conductscience.org/api/trials/v1/NCT01807065/results?page=2