Phase 3 Study of ProstAtak Immunotherapy With Standard Radiation Therapy for Localized Prostate Cancer

  • STATUS
    Recruiting
  • participants needed
    711
  • sponsor
    Candel Therapeutics, Inc.
Updated on 14 December 2020
Investigator
Julie R. Brahmer
Primary Contact
Sibley Memorial Hospital (8.2 mi away) Contact
+76 other location
androgens
tumor cells
antiandrogen therapy
androgen suppression
external beam radiation therapy
cancer vaccine

Summary

The purpose of this study is to evaluate the effectiveness of ProstAtak immunotherapy in combination with radiation therapy for patients with intermediate-high risk localized prostate cancer. ProstAtak kills tumor cells and stimulates a cancer vaccine effect. Killing tumor cells in an immune stimulatory environment induces the body's immune system to detect and destroy cancer cells. ProstAtak has shown synergy with radiation without added toxicity and lower than expected recurrence rates in previous clinical trials. The hypothesis is that ProstAtak can lead to improvement in the clinical outcome for patients with prostate cancer. Participants will be randomized to the ProstAtak or control arm at a 2:1 ratio. Both arms receive standard external beam radiation therapy. Short-term androgen deprivation therapy may be given but is not required.

Details
Treatment ProstAtak®(AdV-tk) + valacyclovir, Placebo + valacyclovir, Aglatimagene besadenovec + valacyclovir
Clinical Study IdentifierNCT01436968
SponsorCandel Therapeutics, Inc.
Last Modified on14 December 2020

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Eligibility

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Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Are you male?
Do you have any of these conditions: Prostate Cancer or Prostate Disorders or Prostatic disorder or Prostate Cancer, Early, Recurrent or Malignant neoplasm of prostate?
Do you have any of these conditions: prostate carcinoma or Prostatic disorder or Prostate Cancer or Malignant neoplasm of prostate or Prostate Cancer, Early, Recurrent or Prostate Disorde...?
Do you have any of these conditions: Prostate Disorders or prostate carcinoma or Prostatic disorder or Malignant neoplasm of prostate or Prostate Cancer, Early, Recurrent or Prostate Canc...?
Do you have any of these conditions: prostate cancers or Malignant neoplasm of prostate or Prostatic disorder or Prostate Cancer, Early, Recurrent or Prostate Cancer or prostate carcinoma...?
Do you have any of these conditions: Prostate Disorders or Prostate Cancer or prostate cancers or Prostate Cancer, Early, Recurrent or prostate carcinoma or Malignant neoplasm of prostate...?
Localized prostate cancer meeting the NCCN criteria of Intermediate Risk or patients having only one NCCN high-risk feature
NCCN Intermediate Risk is defined as having at least one of the following: PSA 10-20 ng/ml, Gleason score =7, T2b-T2c
High Risk with a single high risk feature is defined as having only one of the following: PSA>20 ng/ml, Gleason score 8-10, or T3a
Excluded are those in the following risk groups: Low risk; High risk with more than 1 high risk factor; Locally advanced/very high risk=T3b-T4; Metastatic: N1 or M1
Planning to undergo standard prostate-only external beam radiation therapy
ECOG Performance Status 0-2

Exclusion Criteria

Liver disease, including known cirrhosis or active hepatitis
Patients on systemic corticosteroids (>10mg prednisone per day) or other immunosuppressive drugs
Known HIV+ patients
Regional lymph node involvement or distant metastases
Patients planning to receive whole pelvic irradiation
Prior treatment for prostate cancer, except TURP or ADT. For ADT, it may only be given for a maximum of 6 months
Patients who had or plan to have orchiectomy as the form of hormonal ablation
Known sensitivity or allergic reactions to acyclovir or valacyclovir
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