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Completed

NCT Number: NCT01341652

Phase II PAP Plus GM-CSF Versus GM-CSF Alone for Non-metastatic Prostate Cancer

The investigators are trying to find new methods to treat prostate cancer. The approach the investigators are taking is to try to enhance patients' own immune response against the cancer. In this study the investigators will be testing the effectiveness of a vaccine that may be able to help the body fight prostate cancer.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologic diagnosis of adenocarcinoma of the prostate
  • Completion of local therapy by surgery and/or ablative radiation therapy at least 3 months prior to entry, with removal or ablation of all visible disease, including seminal vesical and/or local lymph node involvement
  • Rising prostate specific antigen (PSA) levels without scan evidence of metastatic disease
  • Asymptomatic or mildly symptomatic and life expectancy of at least 4 months

Exclusion criteria

  • Small cell or other variant prostate cancer histology
  • Evidence of immunosuppression
  • Prior treatment with androgen deprivation except if given neoadjuvantly or adjuvantly with radiation therapy or at time of prostatectomy. In this situation, no more than 24 months of androgen deprivation must have been given and treatment must not have been within 12 months prior to screening for this study.
  • Serum testosterone at screening < 50 ng/dL
  • Known bone metastases or lymph node involvement as determined by bone scan or computed tomography (CT) scan of the abdomen and pelvis within 4 weeks of study entry
  • Prior vaccine therapy for prostate cancer
  • Known allergic reactions to granulocyte-macrophage colony-stimulating factor (GM-CSF)
  • Severe intercurrent medical conditions or laboratory abnormalities that would impart, in the judgment of the Medical Monitor, excess risk associated with study participation or study agent administration

Treatment and study plan

pTVG-HP

Biological

pTVG-HP (100 µg) with rhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period

rhGM-CSF

Biological

rhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period

Other names: GM-CSF, granulocyte-macrophage colony-stimulating factor

Primary outcomes

  1. 2-year Metastasis-Free Survival Rate

    Time frame: 2 years

    2-year Metastasis-Free Survival (MFS) Rate with the development of metastases by conventional imaging used to define progression (as defined by RECIST 1.1 criteria). The 2-year MFS rate estimates which were obtained using the Kaplan-Meier analysis (taking into account censoring) using the intention-to-treat population.

Secondary outcomes

  1. Prostate Specific Antigen (PSA) Doubling Time (DT)

    Time frame: up to 9 months

    PSA DT was calculated using all serum PSA values available from the same clinical laboratory for the specified period by the equation log2/b where b denotes the least-squares estimator of the linear regression model of the log-transformed PSA values on time. Pretreatment PSA DT (3-6 months before treatment, with a minimum of 4 values), on-treatment PSA DT was determined using values from month 3 to month 9.

  2. Number and Severity of Observed Toxicities

    Time frame: 2 years

    Number of participants who experienced any adverse events greater than grade 1 that were determined to be at least possibly related to treatment, highest grade reported per participant for each adverse event (AE). All toxicities were graded using National Cancer Institute Common Terminology Criteria for Adverse Events (version 4). Higher grades indicate more severe toxicities.

  3. Median Time to Radiographic Disease Progression

    Time frame: up to 2 years

    Time to metastasis was determined from the date of registration to the first CT or bone scan that demonstrated metastatic disease. As defined by RECIST 1.1 criteria.

  4. PSA Progression Free Survival

    Time frame: up to 2 years

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Official study title

Randomized Phase II Trial of a DNA Vaccine Encoding Prostatic Acid Phosphatase (pTVG-HP) Versus GM-CSF Adjuvant in Patients With Non-Metastatic Prostate Cancer

Important dates

Study start
2011
Primary completion
2020
Study completion
2020
First posted
Apr 26, 2011
Registry last updated
Jan 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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