Retrospective Analysis of 68Ga-PSMA-PET in Patients With Prostate Cancer: Experience From Brazil (PET-PSMA)

Gallium-68-prostate-specific membrane antigen (68Ga-PSMA) positron emission tomography (PET) has been increasingly used in the management of PCa in Brazil. Thus, the detection of metastatic lesions is improved over traditional methods e.g. MRI and the diagnosis of mCSPC patients has been proportionally increasing. Due to a lack of guidelines and clinical trials including 68Ga-PSMA-PET imaging, the management of these patients is extrapolated from data based on conventional imaging. Treatment decision and duration of treatment for mCSPC patients based on 68Ga-PSMA-PET imaging is currently unknown. 68Ga-PSMA-PET allows a diagnosis of a different set of low volume oligo-metastatic prostate cancer patients. Based on that, a new gap has been built up, since there are no standards of how those patients are managed and how they respond to conventional therapies, to metastasis direct therapy or even if they could be spared of any treatment, reducing costs and toxicities. This patient population has not been included in clinical trials and its critical to generate information on the diagnosis, treatment and outcome of these patients in clinical practice.

Study Overview

• Status: Terminated
• Conditions: Prostate Cancer
• Intervention / Treatment: Radiation: 68Ga-PSMA-PET

• Study Type: Observational
• Enrollment (Actual): 12

Contacts and Locations

Study Locations

• Brazil
  • Rio De Janeiro, Brazil, 22.793-080
    • Instituto COI - Clínicas Oncológicas Integradas (Instituto Américas RJ)
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90.035-000
      • HMV - Hospital Moinhos de Vento
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90.610-000
      • CPO - Centro de Pesquisa em Oncologia do Hospital São Lucas da PUCRS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with localized or biochemical recurrence prostate cancer with no detection of extra-prostatic disease in traditional imaging (bone scan and abdominal and pelvic CT or MRI) who underwent 68Ga-PSMA-PET imaging between October 2015 and January 202.

Description

Inclusion Criteria:

1. Age of at least 18 years at study entry;
2. Histologically confirmed adenocarcinoma of the prostate;
3. 68Ga-PSMA-PET exam performed between October 2015 and January 2021;

4. 68Ga-PSMA-PET performed in one of the following situations:

   • localized disease at diagnosis in patients with no detection of extra-prostatic disease in traditional imaging such as CT scan, MRI and bone scan;
   • biochemical recurrence (according to PCWG3 or defined by the investigator) in patients with no detection of prostatic or extra-prostatic disease in traditional imaging such as CT scan, MRI and bone scan;
5. Traditional imaging (pelvic and abdominal CT or MRI and bone scan) with negative results (no extra-prostatic disease, for localized and biochemical recurrence disease; no prostatic for biochemical recurrence disease) performed within 8 weeks before 68Ga-PSMA-PET;
6. Site and investigator ability to collect adequate patient characteristics, treatment and outcome data from medical records.

Exclusion Criteria:

1. Patients with no disease characteristics accessible in medical records;
2. Cancer diagnosis other than prostate cancer in the last 5 years;
3. Disease detected by traditional imaging techniques (bone scan, CT and/or MRI), meaning extra-prostatic disease, for localized and biochemical recurrence disease; or prostatic disease for biochemical recurrence disease.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Subjects with locally or biochemical recurrence prostate cancer	Radiation: 68Ga-PSMA-PET; Gallium-68-prostate-specific membrane antigen (68Ga-PSMA) positron emission tomography (PET)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The rate of patients with 68Ga-PSMA-PET positive lesions	The rate of patients with 68Ga-PSMA-PET positive lesions [defined as the presence of lesions with 68Ga-PSMA uptake in the prostate (biochemical recurrence) and in extra-prostatic sites (localized disease and biochemical recurrence) in patients with no detected lesions in conventional imaging (no extra prostatic disease, for localized and biochemical recurrence disease; or prostatic disease for biochemical recurrence disease)]	January 2021

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
68Ga-PSMA-PET prostate cancer confirmed detection rate	Defined as the proportion of patients with prostate cancer confirmed by histopathology or with PSA response (reduction ≥ 50% on PSA levels from baseline) in those treated with lesion-directed therapy without ADT in day + 90)	January 2021
Treatment patterns in evaluable patients based on 68Ga-PSMA-PET diagnostic status		January 2021
The percentage of change in initial treatment plan considering the results of 68Ga-PSMA-PET in negative traditional imaging		January 2021
To describe the type of disease monitoring imaging technique (i.e., CT scan, MRI, 68Ga-PSMA-PET) methods after initial diagnosis with 68Ga-PSMA-PET		January 2021
Clinical effectiveness of first-line treatment based on 68Ga-PSMA-PET diagnostic status	(no extra-prostatic disease - localized disease or local recurrence); nodal positive/metastasis negative (regional disease) and metastasis positive (distant disease)	January 2021
Treatment duration of first-line treatment based on 68Ga-PSMA-PET diagnostic status		January 2021

Collaborators and Investigators

• Sponsor: Latin American Cooperative Oncology Group
• Collaborators: Astellas Pharma Inc
• Investigators: Principal Investigator: Andrey Soares, Latin American Cooperative Oncology Group

Publications and helpful links

General Publications

• Suardi N, Gandaglia G, Gallina A, Di Trapani E, Scattoni V, Vizziello D, Cucchiara V, Bertini R, Colombo R, Picchio M, Giovacchini G, Montorsi F, Briganti A. Long-term outcomes of salvage lymph node dissection for clinically recurrent prostate cancer: results of a single-institution series with a minimum follow-up of 5 years. Eur Urol. 2015 Feb;67(2):299-309. doi: 10.1016/j.eururo.2014.02.011. Epub 2014 Feb 18.
• Hofman MS, Lawrentschuk N, Francis RJ, Tang C, Vela I, Thomas P, Rutherford N, Martin JM, Frydenberg M, Shakher R, Wong LM, Taubman K, Ting Lee S, Hsiao E, Roach P, Nottage M, Kirkwood I, Hayne D, Link E, Marusic P, Matera A, Herschtal A, Iravani A, Hicks RJ, Williams S, Murphy DG; proPSMA Study Group Collaborators. Prostate-specific membrane antigen PET-CT in patients with high-risk prostate cancer before curative-intent surgery or radiotherapy (proPSMA): a prospective, randomised, multicentre study. Lancet. 2020 Apr 11;395(10231):1208-1216. doi: 10.1016/S0140-6736(20)30314-7. Epub 2020 Mar 22.
• Caglic I, Kovac V, Barrett T. Multiparametric MRI - local staging of prostate cancer and beyond. Radiol Oncol. 2019 May 8;53(2):159-170. doi: 10.2478/raon-2019-0021.
• Abuzallouf S, Dayes I, Lukka H. Baseline staging of newly diagnosed prostate cancer: a summary of the literature. J Urol. 2004 Jun;171(6 Pt 1):2122-7. doi: 10.1097/01.ju.0000123981.03084.06.
• Hope TA, Eiber M, Armstrong WR, Juarez R, Murthy V, Lawhn-Heath C, Behr SC, Zhang L, Barbato F, Ceci F, Farolfi A, Schwarzenbock SM, Unterrainer M, Zacho HD, Nguyen HG, Cooperberg MR, Carroll PR, Reiter RE, Holden S, Herrmann K, Zhu S, Fendler WP, Czernin J, Calais J. Diagnostic Accuracy of 68Ga-PSMA-11 PET for Pelvic Nodal Metastasis Detection Prior to Radical Prostatectomy and Pelvic Lymph Node Dissection: A Multicenter Prospective Phase 3 Imaging Trial. JAMA Oncol. 2021 Nov 1;7(11):1635-1642. doi: 10.1001/jamaoncol.2021.3771.
• Bandini M, Fossati N, Briganti A. Salvage surgery for nodal recurrent prostate cancer. Curr Opin Urol. 2017 Nov;27(6):604-611. doi: 10.1097/MOU.0000000000000437.
• Kitajima K, Hartman RP, Froemming AT, Hagen CE, Takahashi N, Kawashima A. Detection of Local Recurrence of Prostate Cancer After Radical Prostatectomy Using Endorectal Coil MRI at 3 T: Addition of DWI and Dynamic Contrast Enhancement to T2-Weighted MRI. AJR Am J Roentgenol. 2015 Oct;205(4):807-16. doi: 10.2214/AJR.14.14275.
• Fendler WP, Calais J, Eiber M, Flavell RR, Mishoe A, Feng FY, Nguyen HG, Reiter RE, Rettig MB, Okamoto S, Emmett L, Zacho HD, Ilhan H, Wetter A, Rischpler C, Schoder H, Burger IA, Gartmann J, Smith R, Small EJ, Slavik R, Carroll PR, Herrmann K, Czernin J, Hope TA. Assessment of 68Ga-PSMA-11 PET Accuracy in Localizing Recurrent Prostate Cancer: A Prospective Single-Arm Clinical Trial. JAMA Oncol. 2019 Jun 1;5(6):856-863. doi: 10.1001/jamaoncol.2019.0096.

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2022
• Primary Completion (Actual): January 19, 2024
• Study Completion (Actual): January 19, 2024

Study Registration Dates

• First Submitted: December 20, 2021
• First Submitted That Met QC Criteria: December 22, 2021
• First Posted (Actual): December 23, 2021

Study Record Updates

• Last Update Posted (Estimated): February 21, 2024
• Last Update Submitted That Met QC Criteria: February 19, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms; Molecular Mechanisms of Pharmacological Action; Radiopharmaceuticals; Gallium 68 PSMA-11
• Other Study ID Numbers: LACOG 0121

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No