PSMA PET/CT for Assessment of Recurrent Prostate Cancer

NCT02899312 | Active Not Recruiting

• 1 other identifier: H16-01551
• Study Type: observational
• Target: 2,244
• Locations: 1 country
• Sites: 1

Brief Summary

Prostate cancer (PC) is the third most common cause of cancer death in men. Most patients with localized PC will be cured with surgery or radiation therapy, but up to 35% of patients will have their PC return. Whether it has returned locally or distantly determines which type of treatment they will receive. Current conventional imaging modalities have limitations particularly at low prostate-specific antigen (PSA) levels. This study proposes to use Fluorine-18-2-(3-(1-carboxy-5-\[(6-\[18F\]fluoro-pyridine-3-carbonyl)-amino\]-pentyl)-ureido)-pentanedioic acid (18F-DCFPyL) Positron Emission Tomography / Computer Tomography (PET/CT) scans which targets prostate-specific membrane antigens (PSMA) to detect where in the body the PC has recurred.

Conditions

Prostatic Neoplasms; Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• superiority of 18F-DCFPyL PET/CT over conventional imaging for detection of recurrent prostate cancer.

  Comparison to conventional imaging studies, pathology and clinical follow-up up to 3 years after PSMA imaging.

  3 years after the PSMA PET scan

Secondary Outcomes (1)

• clinical impact of 18F-DCFPyL PET/CT

  6 months after the PSMA PET scan

Interventions

PSMA PET/CT scan DRUG

All participants will undergo the same procedures listed in "Detailed Description" in the protocol section.

Also known as: 18F-DCFPyL PET/CT

Eligibility Criteria

• Age: 19 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The purpose of this study is to evaluate the diagnostic utility of 18F-DCFPyL PET/CT in identifying sites of prostate cancer recurrence where conventional imaging has been negative or equivocal. Concordance with histology, imaging or follow up will be assessed. This study will also assess the clinical impact of 18F-DCFPyL PET/CT on patient management.

You may qualify if:

• Known PC with a biochemical recurrence (BR) after initial curative therapy with radical prostatectomy, with a documented history of failure of PSA to fall to undetectable levels (PSA persistence) or undetectable PSA after radical prostatectomy with a subsequent detectable PSA that increased on 2 or more determinations (PSA recurrence). The patient may have received treatment following documentation of PSA persistence or PSA recurrence. The most recent PSA measurement must be greater than 0.4 ng/mL.
• Participants with findings on other examinations (such as plain x-ray, CT, MRI or bone scintigraphy and others) that are suspicious for metastatic disease but not conclusively diagnostic of metastatic disease.
• Known PC with BR after initial curative therapy with radiation therapy (including brachytherapy), with a PSA level \>2 ng/mL above the nadir after radiation therapy.
• Castration resistant PC with a minimum PSA of 2.0 ng/mL with 2 consecutive rises above the nadir and castrate levels of testosterone (\<1.7 nmol/L). Treatment does not need to be discontinued before the 18F-DCFPyL scan.
• Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less.

You may not qualify if:

• Medically unstable (eg. acute illness, unstable vital signs)
• Unable to lie supine for the duration of imaging
• Unable to provide written consent
• Exceeds safe weight limit of the PET/CT bed (204.5 kg) or unable to fit through the PET/CT bore (diameter 70 cm)

Sponsors & Collaborators

• British Columbia Cancer Agency: lead

Study Sites (1)

BC Cancer

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Related Publications (2)

• Harsini S, Martineau P, Plaha S, Saprunoff H, Chen C, Bishop J, Tyldesley S, Wilson D, Benard F. Prognostic significance of a negative PSMA PET/CT in biochemical recurrence of prostate cancer. Cancer Imaging. 2024 Aug 30;24(1):117. doi: 10.1186/s40644-024-00752-1.

  PMID: 39210431 DERIVED

• Harsini S, Wilson D, Saprunoff H, Allan H, Gleave M, Goldenberg L, Chi KN, Kim-Sing C, Tyldesley S, Benard F. Outcome of patients with biochemical recurrence of prostate cancer after PSMA PET/CT-directed radiotherapy or surgery without systemic therapy. Cancer Imaging. 2023 Mar 17;23(1):27. doi: 10.1186/s40644-023-00543-0.

  PMID: 36932416 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Francois Benard, MD

  BC Cancer

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2016
• First Posted: September 14, 2016
• Study Start: March 16, 2017
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): June 1, 2030
• Last Updated: November 7, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)