Vaccination against prostate cancer

Evaluating the safety and tolerability of intravenous administration of an RNA-lipoplex cancer vaccine targeting three tumor-associated antigens in patients with prostate cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN14654848

Enrollment

Registered

2016-10-10

Start date

2016-10-15

Completion date

Unknown

Last updated

2017-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate cancer Cancer Malignant neoplasm of prostate

Interventions

Weekly (4-6 doses) intravenous administration of RNA-lipoplex for expression of three prostate cancer antigens (PAP, PSMA, STEAP1). RNA-lipoplex vaccine will be administrated intravenously. The patien

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1. Male patients with prostate cancer 2. Age 50-90 years old

Exclusion criteria

Exclusion criteria: Unconfirmed cases of prostate cancer

Design outcomes

Primary

Measure	Time frame
1. Number of adverse events as a measure of safety and tolerability over 90 days 2. Total number of adverse events over 90 days 3. Number of patients with adverse events over 90 days	—

Secondary

Measure	Time frame
1. Change of induced T-cell responses for RNA-Lipoplex vaccine from visit 2 (day 1) to day 90, assessed by immunoassays 2. Vaccine-induced T-cell responses in peripheral blood assessed by immunoassays before vaccination and in week 1, week 2, week 3, week 4, month 2, month 3 of post-vaccination 3. Vaccine-induced antibody responses in peripheral blood assessed by immunoassays before vaccination and in week 1, week 2, week 3, week 4, month 2, month 3 of post-vaccination 4. Change in serum PSA (prostate specific antigen) assessed by immunoassays before vaccination and in week 1, week 2, week 3, week 4, month 2, month 3 of post-vaccination 5. Change in the size of tumor. Patients' tumors will be scanned using MRI and PET/CT before the vaccination and after 3 months. This may be repeated for certain patients after 1 year, depending on the response to the treatment.	—

Measure

Time frame

1. Change of induced T-cell responses for RNA-Lipoplex vaccine from visit 2 (day 1) to day 90, assessed by immunoassays 2. Vaccine-induced T-cell responses in peripheral blood assessed by immunoassays before vaccination and in week 1, week 2, week 3, week 4, month 2, month 3 of post-vaccination 3. Vaccine-induced antibody responses in peripheral blood assessed by immunoassays before vaccination and in week 1, week 2, week 3, week 4, month 2, month 3 of post-vaccination 4. Change in serum PSA (prostate specific antigen) assessed by immunoassays before vaccination and in week 1, week 2, week 3, week 4, month 2, month 3 of post-vaccination 5. Change in the size of tumor. Patients' tumors will be scanned using MRI and PET/CT before the vaccination and after 3 months. This may be repeated for certain patients after 1 year, depending on the response to the treatment.

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Countries

Iran

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026