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Prostate CancersPhase 2ProsPERoNCT02810886

Prospective Evaluation of 68Ga-PSMA PET-CT for Recurrence Detection of Prostate Cancer and Its Impact on Patient Management

A Phase 2 study testing 68Ga-(HBED-CC)-PSMA in people with Prostate Cancers, run by Jules Bordet Institute.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Single arm, phase II exploratory trial to prospectively evaluate the impact of 68Ga-PSMA-PET/CT on the therapeutic management of patients with biological recurrent prostate cancer and negative, equivocal or oligometastatic disease after routine imaging diagnostic work-up. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancers
What is being tested?
68Ga-(HBED-CC)-PSMA
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Oct 2016to 20 Jan 2017
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years old.
  • Histologically-proven prostate adenocarcinoma.
  • Biochemical recurrence (BCR) after local treatment with radical curative intent based on PSA values 1:
  • Following Radical Prostatectomy +/- Radiotherapy: a serum PSA increase confirmed by a second PSA measurement higher than the first one with a value of 0.2 ng/mL or more within minimum of one week.
  • Following primary Radiotherapy: PSA value of 2 ng/ml above the nadir.
  • A continued rise in PSA level despite treatment with curative intent.
Show all 11Show fewer
  • Patients with negative, inconclusive or oligometastatic disease on the Routine Imaging Workup and susceptible to be treated with curative radical intent (salvage treatment).
  • Routing Imaging Workup exams are accepted when performed within 1 month before PSMA-PET/CT (this includes WB-MRI, prostatic/pelvic MRI, and/or Bone Scintigraphy).
  • Patient treatment strategy based on routine diagnostic work-up needs to be recorded after discussion at the Urologic Tumor Board and available before the PSMA PET/CT.
  • ECOG performance status ≤ 2
  • Signed informed consent prior to any study related procedure.

Who cannot join

  • Previous malignancy other than Prostate Cancer (except basocellular or squamous cell skin cancer).
  • Patients treated with palliative chemotherapy or new hormonal therapies like Abiraterone/Enzalutamide.
  • PSA rise while on active treatment (LHRH-agonist, LHRH-antagonist, anti-androgen, maximal androgen blockade, oestrogen). A minimal time window of 1 month is required.
  • Medical castration with Testosterone < 50 ng/dl (1.7 nmol/L).
  • Metastatic patients before inclusion not considered for targeted therapy.
  • Previous treatment with isotopes (Radium, Samarium, Strontium, etc.)
  • All medical conditions that might interfere with the correct performance of imaging scans.
  • Known allergy/sensitivity to 68Ga or HBED-CC coupled substance, or any of the ingredient(s) or excipient(s) of the study medication(s)

About this study

Official title: Prospective Evaluation of 68Ga-PSMA-ligand PET-CT for Recurrence Detection of Prostate Cancer and Its Impact on Patient Management

Single arm, phase II exploratory trial to prospectively evaluate the impact of 68Ga-PSMA-PET/CT on the therapeutic management of patients with biological recurrent prostate cancer and negative, equivocal or oligometastatic disease after routine imaging diagnostic work-up.

Read the detailed description

68Ga-PSMA-ligand PET-CT is a recently developed molecular imaging technique. It is based on the prostate specific membrane antigen (PSMA), a transmembrane protein with a large extracellular domain which is over-expressed on prostate cancer cells surface. Initial experiments used a ligand to the extracellular epitope of PSMA and labelled it with the isotope 68Ga, a positron emitter (68Ga-PSMA-HBED-CC) 5.

Recently published data based on more than 300 patients show recurrence detection rates and tumour to background ratios higher than choline PET-CT, even at low Prostate Specific Antigen (PSA) levels (sensitivity of 70% in PSA<2ng/ml) 6,7. False-positive PSMA findings are not yet reported.

The therapeutic management of biochemical recurrence in prostate cancer depends on the localisation and the extent of the recurrent disease.

In this study, the hypothesis is that 68Ga-PSMA-ligand PET-CT, through its high diagnostic accuracy has a significant impact on the therapeutic management of patients with biochemical recurrence.

Primary objective:

To prospectively evaluate the impact of PSMA-PET/CT on the therapeutic management of patients with biological recurrent prostate cancer and negative, equivocal or oligometastatic disease after routine imaging diagnostic work-up.

The treatment management decision will be recorded at the urologic tumor board (UTB) before and after the PSMA-PET/CT result. Rate of decision change will be calculated.

Secondary objective(s)

  1. To compare detection rates of PSMA PET/CT and Routine Imaging Workup
  2. To search for a predictor of a positive PET scan
  3. To assess diagnostic value of PSMA-PET/CT
  4. To assess PSA response after targeted treatment for oligometastatic disease.
  5. To evaluate the delay to start of Androgen Deprivation Therapy (ADT) from the UTB decision.
  6. To evaluate the time to PSA progression.
Being tested
68Ga-(HBED-CC)-PSMA
Keywords
Prostate Cancer
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 68Ga-(HBED-CC)-PSMADrug

    Also called 68Ga-PSMA, 68Ga-DKFZ-PSMA-11, 68Ga-PSMA-ligand

    68Ga-PSMA-ligand intravenous administration duration is around one minute. Once the patient is injected, the tracer needs 60 minutes to be evenly distributed through the body. PET/CT images will then be performed.

Study groups in NCT02810886
Study groupRoleWhat they receive
Single, arm exploratoryExperimentalPatients will undergo a 68Ga-PSMA PET/CT within 1 month after routine imaging diagnostic work-up.
Receives: Drug: 68Ga-(HBED-CC)-PSMA

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in treatment management are defined as: • Shift to a different therapeutic strategy • Modification of the initial therapeutic strategy • No changes

    Measured: 2 months

Secondary outcomes (6)

  1. Number of positive scans

    • PSMA only positive
    • Routine Imaging only positive
    • Positive in both

    Measured: 2 months

  2. Correlation of positivity with:

    • PSA value at the time of imaging
    • PSA doubling time
    • Gleason score

    Measured: 2 months

  3. Reference diagnosis

    • Histology when available.
    • Normalisation of PSA level after ablative therapy.
    • Morphological and/or biochemical evolution when no target treatment is given.

    Measured: 6 months

  4. A confirmed PSA response is defined as ≥ 30% reduction of the blood level, compared to the baseline value, confirmed by a second PSA value 4 or more weeks later. PSA responses will be evaluated at for up to 6 months

    Measured: 6 months

  5. Androgen Deprivation Therapy (ADT) free survival: time from final Urologic Tumour Board treatment decision to start of ADT treatment during the follow up period of 6 months

    Measured: 6 months

  6. Time to prostate specific antigen (PSA) progression according to Prostate Cancer Clinical Trials Working Group criteria

    • In case of decline from baseline: record time from final Urulogic Tumor Board treatment decision to first PSA increase that is ≥25% and ≥ 2 ng/ml above the nadir OR that is ≥25% above the pretreatment PSA value and which is confirmed by a second value 3 or more weeks later.
    • In case of no decline from baseline: PSA increase that is ≥25% and ≥ 2 ng/ml after 3 months if baseline PSA is ≥2 ng/ml. PSA increase that is ≥25% after 3 months if baseline PSA is < 2 ng/ml.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2016 (estimated)
  2. Study startOct 2016
  3. Primary completion20 Jan 2017
  4. Study completion20 Jan 2017

Why it stopped: Recent publications demonstrating the clinical interest in performing 68Ga-PSMA for recurrence detection of prostate cancer patients with biochemical relapse

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02810886
Sponsor's protocol ID
IJB-PROS-PROSPERO-2016
Acronym
ProsPERo
Status last verified
Aug 2017
First submitted
20 Jun 2016
Last updated
22 Aug 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 68Ga-(HBED-CC)-PSMA in people with Prostate Cancers, run by Jules Bordet Institute.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 22 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in treatment management are defined as: • Shift to a different therapeutic strategy • Modification of the initial therapeutic strategy • No changes (time frame: 2 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02810886.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2017.

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