Skip to main content
OpenTrials
Completed

NCT Number: NCT02920229

68Ga-PSMA HBED-PET/CT in the Evaluation of the Biochemical Relapse in Patients With a History of Prostate Cancer Radically Treated

Single-center, prospective, diagnostic trial in radically treated patients with biochemical recurrence of prostate cancer. Patients with radically treated prostate cancer with biochemical relapse and negativity of all traditional morphological and functional imaging (transrectal ultrasound, bone scan, 18F-FMC PET/CT, CT/MRI) or doubtful imaging of 2-deoxy-2-[fluorine-18] (18F)-fluoromethylcholine (FMC) PET/CT will receive a Gallio-68 (68Ga)- Prostate Specific Membrane Antigen (PSMA) Positron Emission Tomography (PET)/Computed Tomography (CT) scan.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

68Ga-PSMA HBED-PET/CT Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostate Cancer Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

19 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Irst Irccs

Meldola, FC, 47014, Italy

About this study

Single-center, prospective, diagnostic trial. The primary objective of this study is to evaluate the sensitivity of 68Ga-PSMA PET /CT defined as the ratio between the number of 68Ga-PSMA PET /CT positive patients and the number of prostate cancer patients with biochemical relapse and negative standard imaging.

The secondary objectives are:

  • Sensitivity for different Prostatic Specific Antigen (PSA) values (ranges)
  • Sensitivity for different lesion sites
  • Treatment response assessment with a second PET
  • False positives detection during Follow Up (FUP) (with other standard methods and eventually optional biopsy) for patient without any treatment
  • safety 67 evaluable patients will be injected with 100-200 megabecquerel (MBq) 68Ga-PSMA intravenously

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.
  • Radical treatment for prostate cancer (radiotherapy or surgery)
  • 18F-FMC PET/CT negative or doubtful
  • Negativity of all the other traditional morphological and functional imaging (transrectal ultrasound, bone scan, CT/MRI)
  • Patients with PSA progression defined as PSA ≥ 1,0 ng/mL and/or 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

  • No hormonotherapy in the last 6 months
  • No radiotherapy in the last 6 months.
  • Patients with PSA < 1.0 ng/ml
  • Participation in another clinical trial with any investigational agents within 30 days prior to study screening.
  • 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 complete to sign informed consent

Treatment and study plan

68Ga- PSMA

Drug

100-200 MBq of 68Ga-PSMA will be injected intravenously prior to perform the PET/CT

Primary outcomes

  1. the ratio between the number of 68Ga-PSMA PET/CT positive patients and the number of prostate cancer patients with biochemical relapse and negative standard imaging

    Time frame: up to 24 months

    the ratio between the number of 68Ga-PSMA PET/CT positive patients and the number of prostate cancer patients with biochemical relapse and negative standard imaging

Secondary outcomes

  1. Sensitivity for different PSA values (ranges)

    Time frame: up to 24 months

    Sensitivity of 68Ga- PSMA PET/CT for different PSA values (ranges)

  2. Sensitivity for different lesion sites

    Time frame: up to 24 months

    Sensitivity of 68Ga- PSMA PET/CT for different lesion sites

  3. PSA decrease: the receiver operating characteristic (ROC) curves generated by plotting sensitivity versus 1-specificity. Youden's index will be used for determining cut-off value between pos and neg 68Ga-PSMA PET/CT findings

    Time frame: up to 24 months

    for patients that will start an anticancer treatment: evaluate the predictive role of 68Ga- PSMA PET/CT on early response to therapy (hormonotherapy, abiraterone, enzalutamide) taking PSA decrease as a reference.

  4. Evaluation of the concordance between 68Ga- PSMA PET/CT and PET/CT or the others standard methods, performed by the Cohen's kappa coefficient.

    Time frame: up to 24 months

    for patient without any treatment: evaluate the concordance between 68Ga- PSMA PET/CT and other standard methods and eventually optional biopsy

  5. number of treated patients experiencing grade 1 to 4 adverse events

    Time frame: up to 24 months

    number of treated patients undergoing grade 1 to 4 adverse events evaluated according to CTCAE v.4.0

  6. percentage of treated patients experiencing grade 1 to 4 adverse events

    Time frame: up to 24 months

    percentage of treated patients experiencing grade 1 to 4 adverse events

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

68Ga-PSMA, N,N'-Bis(2-hydroxybenzyl)Ethylenediamine-N,N'-Diacetic Acid (HBED)-PET/CT in the Evaluation of the Biochemical Relapse in Patients With a History of Prostate Cancer Radically Treated

Acronym: GaPSMA

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Sep 30, 2016
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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.