Clinical trial of subsequent injection of HVJ-E to those patients who enrolled in the clinical trial of ' Phase I/II clinical trial to assess safety and efficacy of intratumoral and subcutaneous injection of HVJ-E to castration resistant prostate cancer patients '

Clinical trial of subsequent injection of HVJ-E to those patients who enrolled in the clinical trial of ' Phase I/II clinical trial to assess safety and efficacy of intratumoral and subcutaneous injection of HVJ-E to castration resistant prostate cancer patients ' - Subsequent injection of HVJ-E

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000010840

Enrollment

Registered

2013-06-01

Start date

2013-06-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

castration resistant prostate cancer

Interventions

HVJ-E solution

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1. The patient who enrolled in the "Phase I/II clinical trial to assess safety and efficacy of intratumoral and subcutaneous infection of HVJ-E to castration resistant prostate cancer patients" and completed the protocol of this trial. 2. The patient who has provided a written informed consent prior to any study-related procedure. 3. The patient who is not a candidate of standard docetaxel chemotherapy/ refractory to standard docetaxel chemotherapy according to criteria of The Prostate Cancer Clinical Trials Working Group (PCWG2), or deny to receive standard docetaxel chemotherapy. 4. The patient who has PSA value less than 100ng/ml 5. The patient who has a life expectancy for at least 12 weeks or more. 6. The patient who has a ECOG Performance Status Scale of 0 or 1. 7. The patient who has the organs function adequately evaluated by the following lab values; WBC: equal or more than 2,000/microL PLT: equal or more than 75,000/microL Hemoglobin: equal or more than 8.0g/dL GOT: equal or less than 100IU/L GPT: equal or less than 100IU/L T-bil: equal or less than 2.5mg/dL Serum creatinine: equal or less than 2.3mg/dL

Exclusion criteria

Exclusion criteria: 1. The patient who was 'progressive disease (PD)' assessed by PSA value in the "Phase I/II clinical trial to assess safety and efficacy of intratumoral and subcutaneous infection of HVJ-E to castration resistant prostate cancer patients." 2. The patient who has brain metastases. 3. The patient who shows positive immune response by HVJ-E prick test at screening. 4. The patient who has a uncontrolled serious complication such as active infection. 5. The patient who received chemotherapy/ radiotherapy, or immunotherapy within 6 weeks. 6. The patient who has any active autoimmune diseases. 7. The patient who is undergoing on systemic corticosteroids except for the use of maximum 10mg/day oral prednisone over 6 months. 8. The patient who is undergoing on immunosuppressive agents. 9. The patient who has a history of a transplantation of the allogeneic organ. 10. The patent who has inadequate blood property with PT and APTT more than 1.5 times of the upper limit of local reference range. 11. The patient who is inappropriate to be enrolled in this trial judged by the doctors in charge.

Design outcomes

Primary

Measure	Time frame
To assess safety and tolerability of HVJ-E	—

Secondary

Measure	Time frame
1. To evaluate induction of tumor immunity 2. To evaluate anti-tumor effect	—

Countries

Japan

Contacts

Public ContactYasutomo Nakai

Osaka University Graduate School of Medicine Department of Urology

nakai@uro.med.osaka-u.ac.jp

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026

Clinical trial of subsequent injection of HVJ-E to those patients who enrolled in the clinical trial of &#39; Phase I/II clinical trial to assess safety and efficacy of intratumoral and subcutaneous injection of HVJ-E to castration resistant prostate cancer patients &#39;