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68Ga PSMA in Preprostatectomy Patients

Primary Purpose

Prostate Cancer, Prostatic Neoplasm, Prostatic Neoplasms, Castration-Resistant

Status

Unknown status

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Ga-68 PSMA-HBED-CC PET

About this trial

This is an interventional diagnostic trial for Prostate Cancer focused on measuring 68Ga-PSMA-11, (68Ga)Glu-urea-Lys(Ahx)-HBED-CC, 68Ga PSMA-HBED-CC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

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
A PSA level resulted within the past 2 months
Planned prostatectomy with lymph node dissection
Karnofsky performance status (KPS) greater than or equal to 50 (ECOG/WHO 0, 1, or 2) within the last 3 months
Must be treatment naïve (not have received neoadjuvant chemotherapy, radiation therapy, hormonal therapy, androgen deprivation therapy, or focal ablation techniques (e.g., HiFu)
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:

Cannot receive furosemide
Allergy to sulfa or sulfa-containing medications
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

Sites / Locations

University of Iowa Hospitals and Clinics

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

68Ga PSMA PET scan

Arm Description

Ga-68 PSMA-HBED-CC PET

Outcomes

Primary Outcome Measures

Diagnostic accuracy of 68Ga PSMA PET scans for detection of regional pelvic nodal metastases

Sensitivity, specificity, positive, and negative predictive value of 68Ga PSMA PET scan for regional pelvic nodal metastases using pathological results from the prostatecomy

Secondary Outcome Measures

Diagnostic accuracy of 68Ga PSMA PET scans for detection of extra-pelvic nodal metastases, visceral metastases, and osseous metastases.

Sensitivity, specificity, positive, and negative predictive value of 68Ga PSMA PET scan using biopsy results, imaging, and clinical follow-up information.

Full Information

NCT ID

NCT03388346

First Posted

December 22, 2017

Last Updated

January 26, 2021

Sponsor

Michael Graham

Collaborators

Holden Comprehensive Cancer Center, University of Iowa

1. Study Identification

Unique Protocol Identification Number

NCT03388346

Brief Title

68Ga PSMA in Preprostatectomy Patients

Official Title

68Ga PSMA-HBED-CC in Intermediate to High-Risk Preprostatectomy Patients

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Unknown status

Study Start Date

February 16, 2018 (Actual)

Primary Completion Date

December 31, 2021 (Anticipated)

Study Completion Date

June 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Michael Graham

Collaborators

Holden Comprehensive Cancer Center, University of Iowa

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study investigates if a new drug (PSMA) makes prostate cancer easier to identify in positron-emission tomography (PET) imaging. If this works, prostate cancer treatments can be prescribed that match the location of the disease. PSMA is radiolabeled with Gallium-68 (Ga-68). This means a participant receives a small dose of radiation from the drug - less than the annual radiation limit for a medical worker. To test this new drug, participants will receive an injection of Ga-68 PSMA and then have a PET scan. This PET scan, and the reported results, will be entered into the medical record and shared with the treating oncologists.

Detailed Description

This study evaluates PSMA-HBED-CC labelled with Gallium-68, abbreviated 68Ga PSMA. This is a radiotracer that attaches to receptors in the membrane of prostate cancer cells. The 68Ga PSMA is identified using a positron emission tomography (PET) scanner. It is believed that 68Ga PSMA will identify prostate cancer more precisely than normal imaging methods (MRI, CT, or ultrasound). Imaging is key to successful treatment - disease must be identified to be treated. Men who are scheduled to undergo a prostatectomy are invited to test 68Ga PSMA. Participants undergo the 68Ga PSMA PET scan before the prostatectomy. Information from the prostatectomy, including any MRI, CT, or ultrasound imaging, will be used to determine if the 68Ga PSMA PET imaging was better than the standard imaging. Depending on the prostatectomy findings, participants may be invited back for a second 68Ga PSMA scan. This is done if the first scan showed positive lymph nodes or soft tissue metastases but the surgery/biopsy results do not. The results from these scans will be shared with the participant. Results will also be entered into the participant's medical record and shared with the treating oncologists.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer, Prostatic Neoplasm, Prostatic Neoplasms, Castration-Resistant, Prostatic Neoplasm of Uncertain Behavior

Keywords

68Ga-PSMA-11, (68Ga)Glu-urea-Lys(Ahx)-HBED-CC, 68Ga PSMA-HBED-CC

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2, Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

68Ga PSMA PET scan

Arm Type

Experimental

Arm Description

Ga-68 PSMA-HBED-CC PET

Intervention Type

Drug

Intervention Name(s)

Ga-68 PSMA-HBED-CC PET

Other Intervention Name(s)

Gallium-68 PSMA-HBED-CC PET scan

Intervention Description

Ga-68 PSMA-HBED-CC is an investigational PET drug (radionuclide), that binds to the prostate specific receptors. The dose will be about 5mCi (range 3-7 mCi) and administered intravenously.

Primary Outcome Measure Information:

Title

Diagnostic accuracy of 68Ga PSMA PET scans for detection of regional pelvic nodal metastases

Description

Sensitivity, specificity, positive, and negative predictive value of 68Ga PSMA PET scan for regional pelvic nodal metastases using pathological results from the prostatecomy

Time Frame

Within 3 months of prostectomy

Secondary Outcome Measure Information:

Title

Diagnostic accuracy of 68Ga PSMA PET scans for detection of extra-pelvic nodal metastases, visceral metastases, and osseous metastases.

Description

Sensitivity, specificity, positive, and negative predictive value of 68Ga PSMA PET scan using biopsy results, imaging, and clinical follow-up information.

Time Frame

at 3 and 12 months post-prostatecomy

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 A PSA level resulted within the past 2 months Planned prostatectomy with lymph node dissection Karnofsky performance status (KPS) greater than or equal to 50 (ECOG/WHO 0, 1, or 2) within the last 3 months Must be treatment naïve (not have received neoadjuvant chemotherapy, radiation therapy, hormonal therapy, androgen deprivation therapy, or focal ablation techniques (e.g., HiFu) 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: Cannot receive furosemide Allergy to sulfa or sulfa-containing medications 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael Graham, MD, PhD

Organizational Affiliation

University of Iowa

Official's Role

Study Chair

Facility Information:

Facility Name

University of Iowa Hospitals and Clinics

City

Iowa City

State/Province

Iowa

ZIP/Postal Code

52242

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Codified data will be archived and stored in an imaging repository with limited metadata for analysis. Individuals seeking use of these data should contact the study chair. A data sharing contract for a HIPAA limited dataset will need to be executed prior to data sharing.

IPD Sharing Time Frame

Available as requested. Data will be archived indefinitely for research purposes.

IPD Sharing Access Criteria

Individuals seeking use of these data should contact the study chair.

Citations:

PubMed Identifier

26682756

Citation

Maurer T, Gschwend JE, Rauscher I, Souvatzoglou M, Haller B, Weirich G, Wester HJ, Heck M, Kubler H, Beer AJ, Schwaiger M, Eiber M. Diagnostic Efficacy of (68)Gallium-PSMA Positron Emission Tomography Compared to Conventional Imaging for Lymph Node Staging of 130 Consecutive Patients with Intermediate to High Risk Prostate Cancer. J Urol. 2016 May;195(5):1436-1443. doi: 10.1016/j.juro.2015.12.025. Epub 2015 Dec 9.

Results Reference

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PubMed Identifier

27207581

Citation

van Leeuwen PJ, Emmett L, Ho B, Delprado W, Ting F, Nguyen Q, Stricker PD. Prospective evaluation of 68Gallium-prostate-specific membrane antigen positron emission tomography/computed tomography for preoperative lymph node staging in prostate cancer. BJU Int. 2017 Feb;119(2):209-215. doi: 10.1111/bju.13540. Epub 2016 Jun 18.

Results Reference

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PubMed Identifier

25791990

Citation

Eiber M, Maurer T, Souvatzoglou M, Beer AJ, Ruffani A, Haller B, Graner FP, Kubler H, Haberkorn U, Eisenhut M, Wester HJ, Gschwend JE, Schwaiger M. Evaluation of Hybrid (6)(8)Ga-PSMA Ligand PET/CT in 248 Patients with Biochemical Recurrence After Radical Prostatectomy. J Nucl Med. 2015 May;56(5):668-74. doi: 10.2967/jnumed.115.154153. Epub 2015 Mar 19. Erratum In: J Nucl Med. 2016 Aug;57(8):1325.

Results Reference

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PubMed Identifier

25411132

Citation

Afshar-Oromieh A, Avtzi E, Giesel FL, Holland-Letz T, Linhart HG, Eder M, Eisenhut M, Boxler S, Hadaschik BA, Kratochwil C, Weichert W, Kopka K, Debus J, Haberkorn U. The diagnostic value of PET/CT imaging with the (68)Ga-labelled PSMA ligand HBED-CC in the diagnosis of recurrent prostate cancer. Eur J Nucl Med Mol Imaging. 2015 Feb;42(2):197-209. doi: 10.1007/s00259-014-2949-6. Epub 2014 Nov 20.

Results Reference

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PubMed Identifier

28012435

Citation

Green MA, Eitel JA, Fletcher JW, Mathias CJ, Tann MA, Gardner T, Koch MO, Territo W, Polson H, Hutchins GD. Estimation of radiation dosimetry for 68Ga-HBED-CC (PSMA-11) in patients with suspected recurrence of prostate cancer. Nucl Med Biol. 2017 Mar;46:32-35. doi: 10.1016/j.nucmedbio.2016.11.002. Epub 2016 Nov 4.

Results Reference

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68Ga PSMA in Preprostatectomy Patients

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