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A Phase II Immunotherapeutic Trial: Combination Androgen Ablative Therapy and CTLA-4 Blockade as a Treatment for Advanced Prostate Cancer

Phase 2
18 Years
Not Enrolling
Prostatic Neoplasms

Thank you

Trial Information

A Phase II Immunotherapeutic Trial: Combination Androgen Ablative Therapy and CTLA-4 Blockade as a Treatment for Advanced Prostate Cancer

This trial has been designed to ensure the capture of both treatment mechanism-specific data
as well as clinically meaningful data within a relatively compressed study interval. Thus,
this trial is constructed around a single inductive short-term cycle of AA therapy.

Inclusion Criteria:

- Histologically confirmed adenocarcinoma of the prostate staged within 180 days of
study enrollment, stage with or without metastatic disease, with the exclusion of
central nervous system metastases; includes post radical prostatectomy patients with
a rising PSA.

- An initial PSA greater than 4.0 using the Hybritech Assay. For those participants
who have received hormone therapy less than or equal to 21 days, a documented PSA of
greater than or equal to 4.0 prior to initiation of hormone therapy is acceptable.
For those participants who are post radical prostatectomy, a rising PSA is

- Adequate organ function defined as: WBC greater than 3,000; platelets greater than
75,000; total bilirubin less than 1.5mg; transaminases less than 2.5 times upper
limit of normal; serum creatinine less than 2.0 mg or calculated creatinine clearance
greater than 60 mL. All values must be obtained 14 days prior to study entry.

- ECOG performance status of 0 2.

- Patients must be 18 years of age at the time of study entry and able to understand
and sign informed consent.

Exclusion Criteria:

- Underlying other serious medical condition which, in the opinion of the investigator,
precludes study participation. This includes immuno-suppressive disease such as AIDS
or autoimmune disorders such as multiple sclerosis or lupus.

- Patients not recovered from major infections and/or surgical procedures.

- Prior hormonal therapy greater than 21 days prior to enrollment, including estrogens,
LH/RH agonists, antiandrogens, or 5-reductase inhibitors.

- Recent less than 3 months of informed consent usage of immuno suppressive medications
including steroids, Immuran, Cyclosporin. Topical or inhalational steroid use is

- For participants who elect to undergo the baseline transrectal needle biopsy of the
prostate, current usage of systemic anticoagulation therapy, i.e. heparin or coumadin
or inability to discontinue aspirin, aspirin-containing products or ibuprofen for
seven days prior to the prostate biopsies required for this study.

- Prior systemic chemotherapy.

- Prior radiation therapy to the prostate

- Concurrent malignancy, except for adequately treated basal cell or squamous cell skin

- Prior malignancy, unless the patient has been cancer free for five years or more.

- Uncontrolled underlying medical or psychiatric illness, or serious active infections.

- Patient unwilling to complete all required follow-up visits.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Primary endpoint will be the proportion of patients remaining progression-free

Outcome Time Frame:

18 months from the time patient receives the MDX-010.

Safety Issue:


Principal Investigator

Eugene D. Kwon, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic


United States: Food and Drug Administration

Study ID:




Start Date:

June 2005

Completion Date:

November 2010

Related Keywords:

  • Prostatic Neoplasms
  • Neoplasms
  • Prostatic Neoplasms



Mayo ClinicRochester, Minnesota  55905