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

NCT02810886 | Withdrawn Phase 2

• 1 other identifier: IJB-PROS-PROSPERO-2016
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Prostate Cancers

Keywords

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

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

  2 months

Secondary Outcomes (6)

• Number of positive scans

  2 months

• Correlation of positivity with:

  2 months

• Reference diagnosis

  6 months

• 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

  6 months

• 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

  6 months

Study Arms (1)

Single, arm exploratory

EXPERIMENTAL

Patients will undergo a 68Ga-PSMA PET/CT within 1 month after routine imaging diagnostic work-up.

Drug: 68Ga-(HBED-CC)-PSMA

Interventions

68Ga-(HBED-CC)-PSMA DRUG

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.

Also known as: 68Ga-PSMA, 68Ga-DKFZ-PSMA-11, 68Ga-PSMA-ligand

Single, arm exploratory

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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).
• 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)

Sponsors & Collaborators

• Jules Bordet Institute: lead

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

gallium 68 PSMA-11; 68Ga-DKFZ-PSMA-11

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Carlos Artigas, MD

  Jules Bordet Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2016
• First Posted: June 23, 2016
• Study Start: October 1, 2016
• Primary Completion: January 20, 2017
• Study Completion: January 20, 2017
• Last Updated: August 22, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share