Ga-68-PSMA-11 in High-risk Prostate Cancer

NCT ID: NCT03362359

Last Updated: 2020-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 173 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-09
• Study Completion Date: 2020-07-06

Brief Summary

This will be an open-label, single-arm, rater-blinded, multicenter, diagnostic phase 1/2 study to assess safety and diagnostic performance of Ga-68-PSMA-11 positron emission tomography / computer tomography (PET/CT) imaging to detect tumour tissue in patients with newly diagnosed PCA and a high risk for metastasis. As standard of truth, comprehensive histopathology covering prostate and the tributary pelvic lymph node system, will be used. Therefore, only patients scheduled for RP with EPLND (as part of their standard of care) will be eligible.

Patients will be recruited at up to 11 uro-oncological sites in Germany, Austria, and Switzerland, with access to a radiopharmaceutical laboratory, experienced to prepare 68Ga-labelled compounds, and high-quality PET/CT imaging. Upon histological confirmation of PCA, pre-operative staging will be performed according to European Association of Urology (EAU) guideline [Mottet et al. 2015] (to include pelvic MRI or CT and a 99mTc-bone scan), to establish the indication for RP with EPLND. If the indication is confirmed, patients will be invited to participate in the present study. After consenting, review of inclusion and exclusion criteria, as well as screening investigations will be performed by the uro-oncologist (day 0). Thereafter, patients are referred to the collaborating nuclear medicine department for tracer injection, imaging, and post-dose safety evaluations (day 1). Subsequent investigations (day 2 and at end of study) will be made by the uro-oncologist or experienced nuclear medicine physician. Study participation ends on day 7. Routine surgery (RP with EPLND) will be performed after end of study, but no later than 42 days after study inclusion. This sequence allows adequate characterisation of tracer safety, while at the same avoiding unnecessary delay of, or confounding safety signals from therapy.

In total, 150 evaluable patients will be included to receive a single 68Ga dose of 150 MBq (± 50 MBq), administered as i.v. infusion. Due to an assumed dropout rate of 15%, up to 173 patients will be included in study.

Conditions

High-risk Prostate Cancer; Prostate Cancer; Prostate Cancer Metastatic; Lymphnode Metastasis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Ga-68-PSMA-11

Group Type: EXPERIMENTAL

Ga-68-PSMA-11

Intervention Type: DRUG

Single administration of 150 MBq (± 50 MBq), corresponding to a mass dose of ≤ 6 µg. A 2nd administration of 150 MBq (± 50 MBq), corresponding to a mass dose of ≤ 6 µg is possible in the unlikely case of a negative histological result (i.e. no prostate-specific membrane antigen (PSMA) expression in dissected lymph nodes) to verify if PSMA PET-positive tissue as seen on day 1 has not been removed during RP with EPLND.

Interventions

Ga-68-PSMA-11

Single administration of 150 MBq (± 50 MBq), corresponding to a mass dose of ≤ 6 µg. A 2nd administration of 150 MBq (± 50 MBq), corresponding to a mass dose of ≤ 6 µg is possible in the unlikely case of a negative histological result (i.e. no prostate-specific membrane antigen (PSMA) expression in dissected lymph nodes) to verify if PSMA PET-positive tissue as seen on day 1 has not been removed during RP with EPLND.

Intervention Type: DRUG

Other Intervention Names

68Ga-DKFZ-PSMA; 68Ga-PSMA; 68Ga-PSMA(HBED); Glu-NH-CO-NH-Lys-(Ahx)-[68Ga(HBED-CC)]

Eligibility Criteria

Inclusion Criteria

1. Written informed consent.

2. Male ≥ 18 years of age.

3. Histologically confirmed adenocarcinoma of the prostate.

4. High risk for metastasis, defined by either:

1. stadium cT3 according to TNM (primary tumor, regional nodes, metastasis) Classification of Malignant Tumours (TNM), or

2. Gleason Score >7, or

3. Prostate-Specific Antigen (PSA) >20 ng/mL.

5. Patient scheduled for radical prostatectomy (RP) with extended pelvic lymph node dissection (EPLND) according to current guidelines 7 - 60 days after start of study.

6. Consent to practise contraception until end of study (6 days after Ga-68-PSMA-11 injection).

7. Preoperative PCA staging performed according to guidelines, to include a mandatory 99mTc bone scintigraphy and an optional pelvic MRI or CT, not older than 56 days prior to inclusion, according to standard of care.

Exclusion Criteria

1. Known hypersensitivity to Ga-68-PSMA-11 or its components.

2. Presence of known lymph node metastases outside surgical field.

3. More than 5 bone metastases, as determined by 99mTc bone scintigraphy.

4. Previous prostate cancer therapy.

5. Administration of any kind of PET tracer within a period corresponding to 8 half-lives of the respective radionuclide.

6. Any other investigational medicinal product within 30 days prior and 7 days after receiving study medication.

7. Evidence of neuroendocrine small cell carcinoma.

8. Subjects not able to declare meaningful informed consent on their own (e.g. with legal guardian for mental disorders).

9. Simultaneous participation in other clinical trials

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

ABX CRO

OTHER

Sponsor Role: collaborator

Friedrich-Alexander-Universität Erlangen-Nürnberg

OTHER

Sponsor Role: collaborator

University Hospital Freiburg

OTHER

Sponsor Role: collaborator

German Cancer Research Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frederik Giesel, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Heidelberg

Locations

Medizinische Universität Innsbruck

Innsbruck, , Austria

Universitätsklinikum Carl Gustav Carus Dresden

Dresden, , Germany

Friedrich-Alexander-Universität Erlangen

Erlangen, , Germany

Universität Duisburg-Essen

Essen, , Germany

Albert-Ludwigs-Universität Freiburg

Freiburg im Breisgau, , Germany

Universitätsklinikum Heidelberg

Heidelberg, , Germany

Technische Universität München Klinikum rechts der Isar

München, , Germany

Eberhard-Karls-Universität Tübingen

Tübingen, , Germany

Countries

Austria; Germany

Other Identifiers

Ga-68-PSMA-11

Identifier Type: -

Identifier Source: org_study_id