At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed prostate cancer limited to prostate (including seminal vesicle involvement if surgically removed); no lymph node involvement (D1)
- ✓Prior definitive surgery or radiation therapy (or both) completed
- ✓No evidence of metastatic disease on physical exam, CT/MRI, and bone scan within 4 weeks prior to randomization
- ✓Hormone-sensitive prostate cancer: serum total testosterone >150 ng/dL within 4 weeks prior to randomization
- ✕Lymph node involvement (D1)
- ✕Evidence of metastatic disease
- ✕History of eczema, atopic dermatitis, or Darier's disease; acute, chronic, or exfoliative skin conditions (burns, impetigo, varicella zoster, severe acne, contact dermatitis, psoriasis, herpes or other open rashes/wounds)
- ✕Clinically significant cardiomyopathy (due to risk of cardiac inflammation after vaccinia)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Study of PROSTVAC-V (Vaccinia)/TRICOM and PROSTVAC-F (Fowlpox)/TRICOM With GM-CSF in Patients With PSA Progression After Local Therapy for Prostate Cancer
In Brief
A Phase 2 clinical trial evaluating Bicalutamide, Goserelin Acetate, and 3 other interventions for Recurrent Prostate Carcinoma and 4 related conditions. Completed, enrolled 50 participants across 7 sites.
Detailed Summary
Vaccines made from a gene-modified virus may help the body build an effective immune response to kill tumor cells. Biological therapies, such as GM-CSF, may stimulate the immune system in different ways and stop tumor cells from growing. Androgens can cause the growth of prostate cancer cells. Drugs, such as bicalutamide and goserelin, may stop the adrenal glands from making androgens in patients whose tumor cells continue to grow. Giving vaccine therapy together with GM-CSF and, when needed, androgen ablation may be a more effective treatment for prostate cancer. This phase II trial is studying how well giving vaccine therapy together with GM-CSF works in treating patients with prostate cancer that progressed after surgery and/or radiation therapy.
Study Details
Timeline
Interventions
Given orally
Given SC
Given SC
Given SC
Given SC