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Expanded Access Protocol of 68Ga PSMA 11 PET Imaging of Prostate Cancer

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ClinicalTrials.gov Identifier: NCT04452136
Expanded Access Status : Available
First Posted : June 30, 2020
Last Update Posted : June 30, 2020
Sponsor:
Collaborators:
OHSU Center of Radiochemistry Research
Oregon Health and Science University
OHSU Knight Cancer Institute
Information provided by (Responsible Party):
Jeanne Link, OHSU Knight Cancer Institute

Brief Summary:
This study provides expanded access to radiotracer Gallium 68 (68Ga)-prostate-specific membrane antigen (PSMA)-HBED-CC (68Ga-PSMA-11) with Positron Emission Tomography (PET) imaging for participants with intermediate and high risk prostate cancer before prostatectomy or for suspected biochemical recurrence of their prostate cancer. Compared to conventional imaging, 68Ga PSMA-HBED-CC might improve the ability to localize the sites of recurrent or metastatic disease, which helps with surgical and other treatment planning.

Condition or disease Intervention/treatment
Prostatic Neoplasms Prostatic Diseases Prostate Cancer Prostate Cancer Metastatic Prostate Cancer Recurrent Drug: 68GA PSMA-HBED-CC

Detailed Description:

PRIMARY OBJECTIVE:

Provide participants with prostate cancer access to 68Ga PSMA-HBED-CC to localize the site of potential metastatic or recurrent disease.

OUTLINE:

Eligible participants will be intravenously administered 68Ga PSMA-HBED-CC at a dose of 3-7 mCi (111 - 259 MBq), target 5 mCi. The estimated uptake time of the study agent is 75 minutes ± 25 minutes. The targeted uptake time is 60 minutes, with an acceptable range of 50-100 minutes. Following the PET scan with the study agent, participants will undergo either surgical management or treatment for metastatic disease in accordance with institutional standards.

Patients will be observed for 2 hours after injection of the radiotracer, and will be followed-up 1-3 days post injection with a phone call.

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Study Type : Expanded Access
Expanded Access Type : Intermediate-size Population
Official Title: 68Ga PSMA-11 in Patients With Intermediate to High-risk Prostate Cancer Before Prostatectomy or With Biochemical Recurrence of Prostate Cancer.

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer


Intervention Details:
  • Drug: 68GA PSMA-HBED-CC
    Given IV
    Other Name: 68Ga-PSMA-11

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Criteria

Inclusion Criteria:

PLANNED PROSTATECTOMY

  • Biopsy-proven prostate adenocarcinoma
  • Intermediate to high-risk disease, defined as one of the following factors: PSA > 10, T2b or greater, or a Gleason score of 7 or greater.
  • Planned prostatectomy with lymph node dissection
  • Must be treatment naïve (not have received neoadjuvant chemotherapy, radiation therapy, hormonal therapy, androgen deprivation therapy, or focal ablation techniques (e.g., HiFu)

BIOCHEMICAL RECURRENCE

  • Pathologically proven prostate adenocarcinoma. Rising PSA after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy).
  • If post-radical prostatectomy, PSA > 0.2 ng/mL measured > 6 weeks post-operatively and confirmatory persistent PSA greater than 0.2 ng/mL (AUA recommendation for biochemical recurrence).
  • If post-radiation therapy, PSA that is equal to or greater than a 2 mg/mL rise above PSA nadir (ASTRO recommendation for biochemical recurrence).
  • No other malignancy within the past 2 years (skin basal cell or cutaneous superficial squamous cell carcinoma or superficial bladder cancer are exempt from this criterion).

ALL

  • Karnofsky performance status (KPS) >= 50 (ECOG/WHO 0, 1, or 2)
  • Not receiving any other investigational agents (i.e., unlabeled drugs or drugs under an IND for initial efficacy investigations
  • Ability to understand and the willingness to provide informed consent

Exclusion Criteria:

  • History of Stevens-Johnson syndrome
  • Known Paget's disease
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04452136


Contacts
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Contact: Libby Mirande 503-494-4740 Radresearch@ohsu.edu

Locations
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United States, Oregon
OHSU Knight Cancer Institute Available
Portland, Oregon, United States, 97239
Contact: Libby Mirande    503-494-4740    Radresearch@ohsu.edu   
Principal Investigator: Nadine Mallak, M.D.         
Sponsors and Collaborators
Jeanne Link
OHSU Center of Radiochemistry Research
Oregon Health and Science University
OHSU Knight Cancer Institute
Investigators
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Principal Investigator: Nadine Mallak, M.D. OHSU Knight Cancer Institute
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Responsible Party: Jeanne Link, Professor, OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT04452136    
Other Study ID Numbers: STUDY00020072
STUDY00020073 ( Other Identifier: OHSU Knight Cancer Institute IRB Number )
First Posted: June 30, 2020    Key Record Dates
Last Update Posted: June 30, 2020
Last Verified: June 2020
Additional relevant MeSH terms:
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Prostatic Neoplasms
Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Edetic Acid
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action