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

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ClinicalTrials.gov Identifier: NCT02920229
Recruitment Status : Recruiting
First Posted : September 30, 2016
Last Update Posted : January 8, 2018
Sponsor:
Information provided by (Responsible Party):
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
68Ga-PSMA HBED-PET/CT Prostate Cancer Drug: 68Ga- PSMA Not Applicable

Detailed Description:

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 67 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official 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
Study Start Date : November 2015
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: 68Ga- PSMA PET/CT
100-200 MBq of 68Ga-PSMA will be injected intravenously prior to perform the PET/CT
Drug: 68Ga- PSMA
100-200 MBq of 68Ga-PSMA will be injected intravenously prior to perform the PET/CT




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients must have histologically or cytologically confirmed prostate cancer
  2. Male, aged >18 years.
  3. Radical treatment for prostate cancer (radiotherapy or surgery)
  4. 18F-FMC PET/CT negative or doubtful
  5. Negativity of all the other traditional morphological and functional imaging (transrectal ultrasound, bone scan, CT/MRI)
  6. 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.
  7. 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
  8. Participant is willing and able to give informed consent for participation in the study.

Exclusion Criteria:

  1. No hormonotherapy in the last 6 months
  2. No radiotherapy in the last 6 months.
  3. Patients with PSA < 1.0 ng/ml
  4. Participation in another clinical trial with any investigational agents within 30 days prior to study screening.
  5. History of allergic reactions attributed to compounds of similar chemical or biologic composition to Study Agent.
  6. Medical or psychological conditions that would not permit the subject to complete to sign informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02920229


Contacts
Contact: Federica Matteucci, MD +390543739249 federica.matteucci@irst.emr.it

Locations
Italy
Irst Irccs Recruiting
Meldola, FC, Italy, 47014
Contact: Federica Matteucci, MD    +390543739100    federica.matteucci@irst.emr.it   
Principal Investigator: Federica Matteucci, MD         
Sub-Investigator: Ugo De Giorgi, MD         
Sponsors and Collaborators
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
Investigators
Principal Investigator: Federica Matteucci, MD IRST IRCCS, Meldola (FC)

Responsible Party: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
ClinicalTrials.gov Identifier: NCT02920229     History of Changes
Other Study ID Numbers: IRST185.02
2015-003397-33 ( EudraCT Number )
First Posted: September 30, 2016    Key Record Dates
Last Update Posted: January 8, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: undecided

Keywords provided by Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori:
68Ga-PSMA
HBED-PET/CT
biochemical relapse
prostate cancer
radically treated

Additional relevant MeSH terms:
Prostatic Neoplasms
Recurrence
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Disease Attributes
Pathologic Processes