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

NCT03362359 | Completed Phase 1

• 1 other identifier: Ga-68-PSMA-11
• Study Type: interventional
• Target: 173
• Locations: 2 countries
• Sites: 8

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

Keywords

prostatectomy; 68Ga-PSMA-11; EPLND

Outcome Measures

Primary Outcomes (2)

• True positive fraction (TPF) and false positive fraction (FPF) of identified tumour tissue in soft tissue, analysed separately for prostate gland and pelvic lymph nodes, using histopathology as standard of truth.

  up to day 21

• Frequency of occurrence and severity of abnormal findings in safety investigations (physical examination, vital signs, 12-lead ECG, pulse oximetry, clinical laboratory, adverse events, concomitant medication).

  Day 0 - Day 7

Secondary Outcomes (4)

• Number of identified bone lesions, per patient.

  Day 1

• Correlation coefficient of recovery-corrected standardized uptake values (SUV) plotted against Gleason score in primaries after RP

  Day 1

• Percentage of subjects for whom the RP and EPLND will not be conducted

  Day 1

• Quantity of circulating tumour cells in blood

  Day 1

Study Arms (1)

Ga-68-PSMA-11

EXPERIMENTAL

Drug: Ga-68-PSMA-11

Interventions

Ga-68-PSMA-11 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.

Also known as: 68Ga-DKFZ-PSMA, 68Ga-PSMA, 68Ga-PSMA(HBED), Glu-NH-CO-NH-Lys-(Ahx)-[68Ga(HBED-CC)]

Ga-68-PSMA-11

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: male with prostate cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent.
• Male ≥ 18 years of age.
• Histologically confirmed adenocarcinoma of the prostate.
• High risk for metastasis, defined by either:
• stadium cT3 according to TNM (primary tumor, regional nodes, metastasis) Classification of Malignant Tumours (TNM), or
• Gleason Score \>7, or
• Prostate-Specific Antigen (PSA) \>20 ng/mL.
• Patient scheduled for radical prostatectomy (RP) with extended pelvic lymph node dissection (EPLND) according to current guidelines 7 - 60 days after start of study.
• Consent to practise contraception until end of study (6 days after Ga-68-PSMA-11 injection).

You may not qualify if:

• Known hypersensitivity to Ga-68-PSMA-11 or its components.
• Presence of known lymph node metastases outside surgical field.
• More than 5 bone metastases, as determined by 99mTc bone scintigraphy.
• Previous prostate cancer therapy.
• Administration of any kind of PET tracer within a period corresponding to 8 half-lives of the respective radionuclide.
• Any other investigational medicinal product within 30 days prior and 7 days after receiving study medication.
• Evidence of neuroendocrine small cell carcinoma.
• Subjects not able to declare meaningful informed consent on their own (e.g. with legal guardian for mental disorders).
• Simultaneous participation in other clinical trials

Sponsors & Collaborators

• German Cancer Research Center: lead
• ABX CRO: collaborator
• Friedrich-Alexander-Universität Erlangen-Nürnberg: collaborator
• University Hospital Freiburg: collaborator

Study Sites (8)

Medizinische Universität Innsbruck

Innsbruck, 6020, Austria

Location

Universitätsklinikum Carl Gustav Carus Dresden

Dresden, 01307, Germany

Location

Friedrich-Alexander-Universität Erlangen

Erlangen, 91054, Germany

Location

Universität Duisburg-Essen

Essen, 45147, Germany

Location

Albert-Ludwigs-Universität Freiburg

Freiburg im Breisgau, 79106, Germany

Location

Universitätsklinikum Heidelberg

Heidelberg, 69120, Germany

Location

Technische Universität München Klinikum rechts der Isar

München, 81675, Germany

Location

Eberhard-Karls-Universität Tübingen

Tübingen, 72076, Germany

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

gallium 68 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

• Frederik Giesel, Prof. Dr.

  University Hospital Heidelberg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2017
• First Posted: December 5, 2017
• Study Start: October 9, 2017
• Primary Completion: July 6, 2020
• Study Completion: July 6, 2020
• Last Updated: July 27, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); DE (7)