Safety & Activity of P501-AS15 Vaccine as a First-line Treatment for Patients With Hormone-sensitive Prostate Cancer Who Show Rising PSA

NCT00148928 | Completed Phase 1

• 2 other identifiers: 102238104634
• Study Type: interventional
• Target: 25
• Locations: 2 countries
• Sites: 8

Brief Summary

Patients with hormone-sensitive prostate cancer and rising PSA, after primary tumor treatment, will be treated with the P501-AS15 vaccine as out-patients. The maximum dose will be 16 vaccinations, given over a period of approximately one year. Thereafter, the patients' long-term safety and PSA status will be followed over a period of approximately 11 months.

Conditions

Neoplasms, Prostate

Outcome Measures

Primary Outcomes (2)

• Vaccine-related or possibly vaccine-related Grade 3 or 4 adverse event: a. Any Grade 4 toxicity: fatigue (including lethargy, asthenia, malaise) must have a duration of at least 24 hours. b. Any Grade 3 toxicity with a duration of at least 24 hours

  During the study

• Clinical PSA response

Secondary Outcomes (6)

• a. For patients who present a PSA response: The duration of PSA response, The duration of PSA control, The duration of log PSA response.

  During the study

• b. Humoral immune response induced by P501-AS15 vaccine: Anti-CPC seropositivity. Anti-P501 seropositivity.

  At all points during treatment as specified in the study schedule

• c. Cellular immune response induced by P501-AS15 vaccine. Frequency of in vitro cellular immune response to CPC P501.

  At all points during treatment as specified in the study schedule

• d. Any toxicity in terms of solicited symptoms, unsolicited symptoms and serious adverse events.

  During the study

• e. All adverse events, whether or not associated with toxicity.

  During the study

Interventions

P501-AS15 vaccine BIOLOGICAL

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male,
• Aged between 18 and 75 years, inclusive,
• Histologically or cytologically proven adenocarcinoma of the prostate before the initiation of therapy of the primary tumor,
• Radical prostatectomy before progression of disease by rising PSA was established,
• Primary tumor presented a Gleason sum score ≤8,
• Proven progressive hormone-sensitive prostate cancer,
• Serum testosterone level above 50 ng/dl,
• Free of clinically evaluable metastatic disease (other than the rising PSA),
• ECOG Performance Status of 0 or 1,
• Normal organ functions,
• Negative HBV antigen test,
• Negative HCV antibody test,
• The investigator believes that the patient can and will comply with the requirements of the protocol,
• Written, informed consent obtained before enrolment.

You may not qualify if:

• Orchiectomy,
• Received androgen-deprivation therapy, including neo adjuvant androgen-deprivation therapy,
• Any radiotherapy (external beam radiotherapy and/or brachytherapy) for prostate cancer as primary management,
• Receiving treatment with continuous systemic anticancer medications,
• Received chronic administration of immunosuppressants or other immune-modifying drugs within six months before the first vaccine dose,
• Received any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or the administration of such a product is planned during the study period,
• Receiving any immunoglobulins and/or other blood products or has received such products within the three months preceding the first dose of study vaccine or is planned to receive such products during the study period,
• Received any commercial vaccine within the week before the first study vaccination,
• Previous or concomitant malignancies at other sites, except (i) adequately treated non-melanoma skin cancers, and (ii) effectively treated malignancy that has been in remission for \>2 years and is considered by the investigator highly likely to have been cured,
• Any clinical autoimmune disease (except vitiligo),
• Family history of congenital or hereditary immunodeficiency,
• HIV-positive,
• Medical history includes splenectomy or irradiation to the spleen,
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine,
• Any known allergy or hypersensitivity to yeast or yeast products,

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (8)

GSK Investigational Site

Brussels, 1070, Belgium

Location

GSK Investigational Site

Brussels, 1200, Belgium

Location

GSK Investigational Site

Turnhout, 2300, Belgium

Location

GSK Investigational Site

Auxerre, 89011, France

Location

GSK Investigational Site

Besançon, 25030, France

Location

GSK Investigational Site

Paris, 75248, France

Location

GSK Investigational Site

Toulouse, 31403, France

Location

GSK Investigational Site

Villejuif, 94805, France

Location

Related Links

• Results for study 102238 can be found on the GSK Clinical Study Register

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2005
• First Posted: September 8, 2005
• Study Start: March 1, 2005
• Primary Completion: November 7, 2006
• Study Completion: November 7, 2006
• Last Updated: June 2, 2017

Record last verified: 2017-06

Locations

BE (3); FR (5)