68Ga PSMA PET for Patients With Biochemical Recurrence of Prostate Cancer

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ClinicalTrials.gov Identifier: NCT03389451

Recruitment Status : Enrolling by invitation

First Posted : January 3, 2018

Last Update Posted : March 1, 2018

Sponsor:

Collaborators:

University of Iowa

Holden Comprehensive Cancer Center

Information provided by (Responsible Party):

Michael Graham, University of Iowa

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.

Condition or disease	Intervention/treatment	Phase
Prostate Cancer Prostatic Neoplasm Prostatic Neoplasms, Castration-Resistant Prostatic Cancer Recurrent Prostatic Cancer Metastatic	Drug: Ga-68 PSMA-HBED-CC PET	Phase 2 Phase 3

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 have biochemical recurrence of prostate cancer are invited to test 68Ga PSMA. Participants undergo the 68Ga PSMA PET scan before further treatment. Clinical information, including any MRI, CT, or ultrasound imaging and biopsy/surgery information, will be used to determine if the 68Ga PSMA PET imaging was better than the standard imaging. The study team will collect this information for about 1 year after the PSMA scan.

Depending on 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 a surgery or biopsy result does 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.

Study Design


Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	40 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Diagnostic
Official Title:	68Ga PSMA-HBED-CC PET in Patients With Biochemical Recurrence
Actual Study Start Date :	February 16, 2018
Estimated Primary Completion Date :	December 31, 2020
Estimated Study Completion Date :	December 31, 2022

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Prostate cancer

MedlinePlus related topics: Nuclear Scans

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: 68Ga PSMA PET scan Ga-68 PSMA-HBED-CC PET	Drug: Ga-68 PSMA-HBED-CC PET 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. Other Name: Gallium-68 PSMA-HBED-CC PET scan

Outcome Measures

Primary Outcome Measures :

Determine sensitivity on a per-subject basis of 68Ga PSMA PET scans for detection of tumor location [ Time Frame: Up to 12 months after 68Ga PSMA PET scan ]
Sensitivity will be determined on a per-subject basis of 68Ga PSMA PET scan for detection of tumor sites, confirming against imaging, clinical follow-up, and histopathology when available.

Secondary Outcome Measures :

Determine positive predictive value on a per-subject and per-region basis of 68Ga PSMA PET scans for detection of tumor location [ Time Frame: 3 and 12 months after 68Ga PSMA PET scan ]
Positive predictive value will be determined on a per-subject basis of 68Ga PSMA PET scan for detection of tumor sites, confirming against imaging, clinical follow-up, and histopathology when available.
Evaluate adverse events of 68Ga PSMA PET scan [ Time Frame: through 24 hours post-injection of 68Ga PSMA ]
Adverse events will be determined through clinical assessment and categorized by CTCAE 4.03

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Pathologically proven prostate adenocarcinoma
Rising PSA after definitive therapy with prostatecomy or radiation therapy (external beam or brachytherapy)
If post-radical prostatecomy, PSA > 0.2 ng/mL measured > 6 weeks post-operative and confirmed persistent PSA > 0.2 ng/mL (AUA recommendation for biochemical recurrence)
If post-radiation therapy, PSA that is ≥ 2 mg/mL rise above PSA nadir (ASTRO recommendation for biochemical recurrence)
Not receiving any other investigational agents (i.e., unlabeled drugs or drugs under an IND for initial efficacy investigations)
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)
Karnofsky performance status (KPS) ≥ 50 (ECOG/WHO of 0, 1, or 2)
Ability to understand and willingness to provide informed consent

Exclusion Criteria:

Cannot receive furosemide
History of Stevens Johnson syndrome
History or diagnosis of Paget's disease
Malignancy other than current disease under study
Allergy to sulfa or sulfa-containing medications
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

Contacts and Locations

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): NCT03389451

Locations


United States, Iowa
The University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States, 52242

Sponsors and Collaborators

Michael Graham

University of Iowa

Holden Comprehensive Cancer Center

Investigators


Study Chair:	Michael M. Graham, MD, PhD	University of Iowa

More Information

Publications:

Maurer T, Gschwend JE, Rauscher I, Souvatzoglou M, Haller B, Weirich G, Wester HJ, Heck M, Kübler 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):1436-43. doi: 10.1016/j.juro.2015.12.025. Epub 2015 Dec 9.

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.

Eiber M, Maurer T, Souvatzoglou M, Beer AJ, Ruffani A, Haller B, Graner FP, Kübler H, Haberkorn U, Eisenhut M, Wester HJ, Gschwend JE, Schwaiger M. Evaluation of Hybrid ⁶⁸Ga-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.

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.

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 (68)Ga-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.


Responsible Party:	Michael Graham, Professor, University of Iowa
ClinicalTrials.gov Identifier:	NCT03389451 History of Changes
Other Study ID Numbers:	201709730
First Posted:	January 3, 2018 Key Record Dates
Last Update Posted:	March 1, 2018
Last Verified:	February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes
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.
Supporting Materials:	Clinical Study Report (CSR)
Time Frame:	Available as requested. Data will be archived indefinitely for research purposes.
Access Criteria:	Individuals seeking use of these data should contact the study chair.


Studies a U.S. FDA-regulated Drug Product:		Yes
Studies a U.S. FDA-regulated Device Product:		No

Keywords provided by Michael Graham, University of Iowa:


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

Additional relevant MeSH terms:


Prostatic Neoplasms Neoplasms Recurrence Prostatic Neoplasms, Castration-Resistant Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Genital Diseases, Male Prostatic Diseases	Disease Attributes Pathologic Processes N,N'-bis(2-hydroxybenzyl)ethylenediamine-N,N'-diacetic acid Edetic Acid Chelating Agents Sequestering Agents Molecular Mechanisms of Pharmacological Action Anticoagulants Calcium Chelating Agents

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