Dendreon Lymph Node Biopsy in Metastatic Castrate-Resistant Prostate Cancer

NCT02036918 | Completed Phase 1

• 1 other identifier: Pro00047231
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate patients with metastatic castrate-resistant prostate cancer (mCRPC) undergoing treatment with sipuleucel-T for evidence of treatment-associated immune activation in lymph nodes and peripheral blood.

Conditions

Prostate Cancer

Keywords

castrate resistant prostate cancer; metastatic; sipuleucel-T; lymphadenectomy; Excisional lymph node biopsy

Outcome Measures

Primary Outcomes (14)

• anti-PA2024 immune response in lymph node-derived leukocytes

  Proportion of patients with lymph node-derived leukocytes showing anti-PA2024 activity as measured by IFNγ ELISPOT

  Lymph node biopsy, approximately 10 weeks

• anti-PAP immune response in lymph node-derived leukocytes

  Proportion of patients with lymph node-derived leukocytes showing anti-PAP activity as measured by IFNγ ELISPOT

  Lymph node biopsy, approximately 10 weeks

• anti-PA2024 immune response in PBMCs

  Proportion of patients with PBMC samples showing anti-PA2024 activity as measured by IFNγ ELISPOT at each time point

  Baseline

• anti-PAP immune response in PBMCs

  Proportion of patients with PBMC samples showing anti-PAP activity as measured by IFNγ ELISPOT at each time point

  Baseline

• anti-PA2024 immune response in PBMCs

  Proportion of patients with PBMC samples showing anti-PA2024 activity as measured by IFNγ ELISPOT at each time point

  Prior to sipuleucel-T infusion 2, approximately 6 weeks

• anti-PAP immune response in PBMCs

  Proportion of patients with PBMC samples showing anti-PAP activity as measured by IFNγ ELISPOT at each time point

  Prior to sipuleucel-T infusion 2, approximately 6 weeks

• anti-PA2024 immune response in PBMCs

  Proportion of patients with PBMC samples showing anti-PA2024 activity as measured by IFNγ ELISPOT at each time point

  Prior to sipuleucel-T infusion 3, approximately 8 weeks

• anti-PAP immune response in PBMCs

  Proportion of patients with PBMC samples showing anti-PAP activity as measured by IFNγ ELISPOT at each time point

  Prior to sipuleucel-T infusion 3, approximately 8 weeks

• anti-PA2024 immune response in PBMCs

  Proportion of patients with PBMC samples showing anti-PA2024 activity as measured by IFNγ ELISPOT at each time point

  2 weeks after the last sipuleucel-T infusion

• anti-PAP immune response in PBMCs

  Proportion of patients with PBMC samples showing anti-PAP activity as measured by IFNγ ELISPOT at each time point

  2 weeks after the last sipuleucel-T infusion

• anti-PA2024 immune response in PBMCs

  Proportion of patients with PBMC samples showing anti-PA2024 activity as measured by IFNγ ELISPOT at each time point

  3 months post-treatment

• anti-PAP immune response in PBMCs

  Proportion of patients with PBMC samples showing anti-PAP activity as measured by IFNγ ELISPOT at each time point

  3 months post-treatment

• anti-PA2024 immune response in PBMCs

  Proportion of patients with PBMC samples showing anti-PA2024 activity as measured by IFNγ ELISPOT at each time point

  6 months post-treatment

• anti-PAP immune response in PBMCs

  Proportion of patients with PBMC samples showing anti-PAP activity as measured by IFNγ ELISPOT at each time point

  6 months post-treatment

Secondary Outcomes (2)

• Serum anti-PA2024 antibody level

  Baseline, up to 6 months post-treatment

• serum anti-PAP antibody level

  Baseline, up to 6 months post-treatment

Study Arms (2)

Arm A

ACTIVE COMPARATOR

Pre-treatment control group will be randomized to immediate lymph node biopsy followed by sipuleucel-T immunotherapy.

Drug: Sipuleucel-T; Procedure: Lymph Node Biopsy

Arm B

EXPERIMENTAL

Post-treatment experimental group will be randomized to immediate sipuleucel-T immunotherapy followed by lymph node biopsy.

Drug: Sipuleucel-T; Procedure: Lymph Node Biopsy

Interventions

Sipuleucel-T DRUG

Also known as: Provenge

Arm A; Arm B

Lymph Node Biopsy PROCEDURE

Also known as: lymphadenectomy, lymph node dissection, excisional lymph node biopsy

Arm A; Arm B

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• ECOG performance status 0 or 1
• Life expectancy of ≥ 6 months
• Minimally-symptomatic or asymptomatic, castrate-resistant metastatic prostate cancer, as evidenced by all of the following:
• Histologically-confirmed diagnosis of adenocarcinoma of the prostate
• Evidence of adequate androgen deprivation, as evidence by one of the following:
• Bilateral orchiectomy
• Ongoing LHRH agonist (e.g. leuprolide, goserelin) and serum testosterone \<50 ng/dl
• Ongoing LHRH antagonist (e.g. degarelix) and serum testosterone \<50 ng/dl
• Evidence of prostate cancer resistance to castration, as evidenced by one of the following:
• consecutive PSA levels that are ≥ 50% above the PSA nadir achieved on ADT and obtained at least 1 week apart
• CT or MRI based evidence of disease progression (soft tissue or nodal) according to PCWG2 criteria or RECIST 1.1 criteria, or at least 1 new bone scan lesion as compared to the most immediate prior radiologic studies.
• Presence of non-visceral metastases on imaging
• Absence of major symptoms directly attributable to prostate cancer, with the following permissible exceptions:
• Ureteral obstruction secondary to pelvic or retroperitoneal lymphadenopathy

You may not qualify if:

• Prior treatment with sipuleucel-T
• Allergy to any component of sipuleucel-T
• Inability to undergo leukapheresis
• History of neuroendocrine variants of prostate cancer, including small cell carcinoma of the prostate
• Extensive prior surgery/radiation present that would render the biopsy highly complex and the risk of intraoperative injury high
• Any chronic medical condition requiring daily corticosteroids or other immunosuppressants
• Solid organ transplantation requiring immunosuppression
• Visceral (e.g. lung, liver) metastases
• Known brain metastases
• History of spinal cord compression
• Untreated/unstabilized pathologic long bone fractures
• Other malignancy, except non-melanoma skin cancer, with a ≥ 30% probability of recurrence within 24 months
• Administration of any investigational therapeutic within 30 days of registration
• Any condition which, in the opinion of the investigator, would preclude participation in this trial

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasm Metastasis

Interventions

sipuleucel-T; Sentinel Lymph Node Biopsy; Lymph Node Excision

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Brant Inman, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2014
• First Posted: January 15, 2014
• Study Start: March 1, 2014
• Primary Completion: February 6, 2019
• Study Completion: February 6, 2019
• Last Updated: March 31, 2020

Record last verified: 2020-03

Locations

US (1)