Phase 3
Completed N=127
Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
Source: ClinicalTrials.gov NCT00005947 ↗Enrolled (actual)
127
Serious AEs
23.6%
Results posted
Nov 2010
Primary outcomePrimary: Time to Objective Disease Progression — 11.7; 10.0 Weeks — p=0.052
Summary
Rationale: Vaccines may make the body build an immune response to kill tumor cells. It is not yet known if vaccine therapy is effective for prostate cancer.
Purpose: Randomized phase III trial to determine the effectiveness of vaccine therapy in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Objective Disease Progression |
11.7; 10.0 | 0.052 |
| SECONDARY Overall Survival |
25.9; 21.4 | 0.010 sig |
Eligibility Criteria
Inclusion Criteria include:
- Metastatic disease as evidenced by soft tissue and/or bony metastases.
- Baseline PSA value of at least 5 ng/mL. All subjects must have stable or rising PSA.
- Tumor progression after hormonal therapy.
- Hormonal therapy consisting of castration by orchiectomy or LHRH agonists for treatment of prostate cancer. Castration levels of testosterone ( 25% decrease in PSA) but at the time of registration demonstrated tumor progression. A subject is eligible if he failed to respond to antiandrogen withdrawal.
- Subjects have no cancer-related pain and do not regularly require analgesics for cancer-related pain.
- ECOG Performance Status of 0 or 1.
- Life expectancy of at least 16 weeks.
- Adequate hematologic, renal, and liver function.
Exclusion Criteria include:
- Visceral organ metastases (e.g., liver, lung, brain) or cytologically positive effusions (e.g., pleural effusions or ascites).
- Metastatic disease expected to be in need of radiation therapy within 4 months.
- Concurrent therapy with experimental agents.
- Systemic corticosteroids at doses greater than 40 mg hydrocortisone per day for any reason other than treatment of prostate cancer within the previous 6 months without prior approval.
Please note that there are additional eligibility criteria. The study center will determine if you meet all of the criteria.
Data sourced from ClinicalTrials.gov (NCT00005947). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.