Gallium-68 PSMA-11 PET in Patients With Biochemical Recurrence

NCT03396874 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: HUM125841
• Study Type: interventional
• Target: 1,435
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the value of Gallium-68 labeled PSMA (68Ga-PSMA) for PET/CT imaging of prostate cancer recurrence. 68Ga-PSMA is a radioactive molecule, which binds to prostate cancer cells. Together with a PET/CT scanner, the distribution of 68Ga-PSMA can be determined in the body. To test this new drug, participants will receive an intravenous injection of Ga-68-PSMA and then have a PET/CT scan. The scan results will be made available to study participants and treating physicians.

Conditions

Prostate Cancer; Prostate Adenocarcinoma; Prostate Cancer Metastatic; Prostate Cancer Recurrent

Outcome Measures

Primary Outcomes (1)

• Positive Predictive Value (PPV) of 68Ga PSMA PET/CT for Detecting Prostate Cancer on a Per-patient Basis Confirmed by Histopathology.

  Evaluation of the positive predictive value (PPV) (true positives / (true positives + false positives)) of 68Ga-PSMA-11 PET for presence of prostate cancer confirmed by histopathology on a per-patient basis. On a per-patient basis, the PPV of conventional imaging ranges between 30-50%. The null hypothesis is that the PPV at 50% will be tested against the alternative hypothesis that the PPV is greater than 50%. The result of a histopathological examination of a PSMA positive lesion is obtained when available. Such data are collected as a single time point up to 12 months following the scan.

  Up to 12 months after 68Ga-PSMA scan

Secondary Outcomes (4)

• Sensitivity and PPV on a Per-patient and Per-region-basis of 68Ga-PSMA PET/CT for Detection of Tumor Location.

  Up to 12 months after 68Ga-PSMA scan

• Adverse Events of 68Ga-PSMA Administration

  24 - 72 hours post administration

• Detection Rates on a Per-patient Basis of 68Ga-PSMA-11 PET/CT

  12 months post scan

• Impact of 68Ga-PSMA-11 PET on Clinical Management in BCR Patients

  2 days to 12 months following the scan.

Study Arms (1)

Patient participants

EXPERIMENTAL

PET/CT imaging

Drug: 68Ga-PSMA

Interventions

68Ga-PSMA DRUG

PET/CT imaging with 68Ga-PSMA: 68Ga-PSMA is an investigational radioactive drug that binds to receptors on prostate cancer cells. The intravenously administered drug dose will be about 5 mCi (range 3-7 mCi).

Also known as: Gallium-68 PSMA-HBED-CC, Gallium-68 PSMA-11

Patient participants

Eligibility Criteria

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

You may qualify if:

• Histopathological proven prostate adenocarcinoma.
• Rising prostate specific antigen (PSA) after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy).
• Post radical prostatectomy (RP) - according to American Urological Association (AUA) recommendation criteria: PSA greater than 0.2 ng/mL measured more than 6 weeks after RP and confirmatory persistent PSA greater than 0.2 ng/mL.
• Post-radiation therapy - according to ASTRO-Phoenix consensus definition: Nadir + greater than or equal to 2 ng/mL rise in PSA.
• Karnofsky performance status of ≥ 50.
• Age ≥ 18.
• Ability to understand a written informed consent document, and the willingness to sign it.

You may not qualify if:

• Current investigational therapy for prostate cancer.
• Unable to lie flat, still or tolerate a PET/CT scan.
• Prior history of a malignancy within the last 2 years, except skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized, and except superficial bladder cancer.
• Prisoner.

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

• Abghari-Gerst M, Armstrong WR, Nguyen K, Calais J, Czernin J, Lin D, Jariwala N, Rodnick M, Hope TA, Hearn J, Montgomery JS, Alva A, Reichert ZR, Spratt DE, Johnson TD, Scott PJH, Piert M. A Comprehensive Assessment of 68Ga-PSMA-11 PET in Biochemically Recurrent Prostate Cancer: Results from a Prospective Multicenter Study on 2,005 Patients. J Nucl Med. 2022 Apr;63(4):567-572. doi: 10.2967/jnumed.121.262412. Epub 2021 Jul 29.

  PMID: 34326126 RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

gallium 68 PSMA-11

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

For Outcome Measure 5, a quality check was performed of the results by analyzing electronic medical records. The analysis showed the questionnaire responses about treatment plans collected post-scan did not align with the actual treatments listed in the medical records.

Results Point of Contact

• Title: Morand Piert
• Organization: University of Michigan

mpiert@med.umich.edu

734-936-5385

Study Officials

• Morand R Piert, M.D.

  University of Michigan

  PRINCIPAL INVESTIGATOR

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: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 4, 2018
• First Posted: January 11, 2018
• Study Start: February 9, 2018
• Primary Completion: August 9, 2022
• Study Completion: August 9, 2022
• Last Updated: November 3, 2023
• Results First Posted: November 3, 2023

Record last verified: 2023-10

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)