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

NCT03389451 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 201709730
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigates if a new prostate-specific membrane antigen (PSMA) drug 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.

Conditions

Prostate Cancer; Prostatic Neoplasm; Prostatic Neoplasms, Castration-Resistant; Prostatic Cancer Recurrent; Prostatic Cancer Metastatic

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Sensitivity of Ga 68-labeled PSMA-11 Positron Emission Tomography/Computed Tomography (PET/CT) for the Detection on a Per Patient Basis

  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.

  Up to 12 months after 68Ga PSMA PET scan

Secondary Outcomes (5)

• Positive Predictive Value (PPV) of Ga 68-labeled PSMA-11 Positron Emission Tomography/Computed Tomography (PET/CT) for the Detection of Tumor Location on a Per Patient Basis

  Up to 12 months after 68Ga PSMA PET scan

• Positive Predictive Value (PPV) of Ga 68-labeled PSMA-11 Positron Emission Tomography/Computed Tomography (PET/CT) for the Detection of Prostate Bed Lesions on a Per Patient Basis

  Up to 12 months after 68Ga PSMA PET scan

• Positive Predictive Value (PPV) of Ga 68-labeled PSMA-11 Positron Emission Tomography/Computed Tomography (PET/CT) for the Detection of Regional Pelvic Nodal Metastases on a Per Patient Basis

  Up to 12 months after 68Ga PSMA PET scan

• Positive Predictive Value (PPV) of Ga 68-labeled PSMA-11 Positron Emission Tomography/Computed Tomography (PET/CT) for the Detection of Extra-pelvic/Visceral Nodal Metastases on a Per Patient Basis

  Up to 12 months after 68Ga PSMA PET scan

• Positive Predictive Value (PPV) of Ga 68-labeled PSMA-11 Positron Emission Tomography/Computed Tomography (PET/CT) for the Detection of Osseous Metastases on a Per Patient Basis

  Up to 12 months after 68Ga PSMA PET scan

Study Arms (1)

68Ga PSMA PET scan

EXPERIMENTAL

Ga-68 PSMA-HBED-CC PET

Drug: Ga-68 PSMA-HBED-CC PET

Interventions

Ga-68 PSMA-HBED-CC PET DRUG

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.

Also known as: Gallium-68 PSMA-HBED-CC PET scan

68Ga PSMA PET scan

Eligibility Criteria

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

You may qualify if:

• Pathologically proven prostate adenocarcinoma
• Rising prostate-specific antigen (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-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

You may not qualify if:

• 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

Sponsors & Collaborators

• Michael Graham PhD, MD: lead
• University of Iowa: collaborator
• Holden Comprehensive Cancer Center: collaborator

Study Sites (1)

The University of Iowa Hospitals & Clinics

Iowa City, Iowa, 52242, United States

Location

Related Publications (5)

• 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.

  PMID: 26682756 BACKGROUND

• 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.

  PMID: 27207581 BACKGROUND

• 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.

  PMID: 25791990 BACKGROUND

• 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.

  PMID: 25411132 BACKGROUND

• 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.

  PMID: 28012435 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms; Prostatic Neoplasms, Castration-Resistant

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Michael Graham
• Organization: University of Iowa Health Care

michael-graham@uiowa.edu

319-356-4302

Study Officials

• Michael M. Graham, MD, PhD

  University of Iowa

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 22, 2017
• First Posted: January 3, 2018
• Study Start: February 16, 2018
• Primary Completion: July 23, 2019
• Study Completion: July 23, 2019
• Last Updated: July 12, 2024
• Results First Posted: June 28, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.

Locations

US (1)