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Completed

NCT Number: NCT04775602

Experimental Study to Evaluate the Impact of 18 Fluoro-PSMA (18F-PSMA) PET / CT in the Management of Patients with Prostate Cancer.

Single-center, prospective, open-label, not randomized, diagnostic phase II trial in the management of patients with prostate cancer.

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Key information

Conditions

18F-PSMA Disease Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Prostate Cancer Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Irst Irccs

Meldola, FC, 47014, Italy

About this study

Single-center, prospective, open-label, not randomized, diagnostic phase II trial in the management of patients with prostate cancer. The aim of this study is to evaluate the additional diagnostic role of 18F- PSMA PET /CT (sensitivity) in patients with prostate cancer with biochemical relapse compared to other diagnostic methods routinely used. The primary objective is to evaluate the sensitivity of 18F-PSMA PET/CT defined as the ratio between the number of 18F-PSMA PET/CT positive patients and the number of prostate cancer patients with biochemical relapse and negative standard imaging.Patients enrolled in the study would benefit from a more accurate but above all earlier diagnosis of disease recurrence sites, thus being able to undergo targeted therapies, with a clear impact on the clinical management of the disease.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients must have histologically or cytologically confirmed prostate cancer
  • Male, aged >18 years on the day of signing and dating the informed consent form.
  • Previous radical treatment for prostate cancer (radiotherapy or surgery)
  • Negativity of all the other traditional morphological and functional imaging or doubtful imaging of 18F-FMC PET/CT
  • Patients with PSA progression defined as PSA ≥ 0.2 ng/mL and PSA rising defined as 2 subsequent values showing PSA increase at least 1 week apart.
  • Male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study and for 3 months thereafter
  • Participant is willing and able to give informed consent for participation in the study.

Exclusion criteria

  • Hormonotherapy in the last 6 months
  • No radiotherapy in the last 6 months.
  • Participation in another clinical trial with any investigational agents within 30 days prior to prior informed consent date
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to Study Agent.
  • Medical or psychological conditions that would not permit the subject to sign the informed consent

Treatment and study plan

18F-PSMA

Drug

18F-PSMA will be injected intravenously at a dosage of 200-250 megabecquerel (MBq) prior to perform Image acquisition (Topogram, CT, PET)

Primary outcomes

  1. Diagnostic role of 18F- PSMA PET /CT (sensitivity)

    Time frame: Up to 30 months

    Sensitivity of 18F-PSMA PET/CT will be calculated as the ratio between the number of 18F- PSMA PET/CT positive patients and number of patients with radically treated prostate cancer with biochemical relapse and negativity of traditional morphological imaging.

Secondary outcomes

  1. Sensitivity for different PSA values (ranges)

    Time frame: Up to 30 months

    Sensitivity of 18F-PSMA PET/CT will be stratified respect to different ranges of Prostate-Specific Antigen (PSA) values.

  2. Sensitivity for different lesion sites

    Time frame: Up to 30 months

    Sensitivity of 18F-PSMA PET/CT will be stratified respect to different sites of lesion.

  3. predictive role of 18F-PSMA PET/CT on disease status according to standard imaging and PSA evaluation.

    Time frame: Up to 30 months

    To evaluate the predictive role of 18F-PSMA PET/CT on disease status, for patients that will start an anticancer treatment. It will be performed the receiver operating characteristic (ROC) curves generated by plotting sensitivity versus 1-specificity The best cut-off value for distinguishing between positive and negative 18F- PSMA PET/CT findings will be determined using Youden's index.

  4. evaluation of the concordance between 18F-PSMA PET/CT and other methods

    Time frame: Up to 30 months

    To evaluate the concordance between 18F-PSMA PET/CT and PET/CT or the others standard methods, for patients without any treatment, it will be performed by Cohen's kappa coefficient

  5. 18F-PSMA Safety: treated patients undergoing grade 1 to 4 adverse event

    Time frame: Up to 30 months

    Number and percentage of treated patients undergoing grade 1 to 4 adverse events will be tabulated according to CTCAE version 5.0.

Sponsors and collaborators

Lead sponsor

Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS

Other

Registry information

Official study title

Experimental Study to Evaluate the Impact of 18F-PSMA PET / CT in the Management of Patients with Prostate Cancer.

Acronym: F-PSMA

Important dates

Study start
2020
Primary completion
2023
Study completion
2024
First posted
Mar 1, 2021
Registry last updated
Jan 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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