68Ga-PSMA-R2 in Patients With Biochemical Relapse (BR) and Metastatic Prostate Cancer (mPCa)

Overview

Assessment of the safety and tolerability of a single administration of 3 mega Becquerel (MBq)/kg, but not less than 150 MBq and not more than 250 MBq, of 68Ga-PSMA-R2, to assess the pharmacokinetics (PK), biodistribution, and dosimetry of 68Ga-PSMA-R2, and to establish the optimal imaging method for determining location and burden of positive lesions in adult male patients with biochemical relapse (BR) and metastatic prostate cancer (mPCa).

Full Title of Study: “A Phase 1/2 Open-label, Multi-center, Safety and Tolerability Study of a Single Dose of 68Ga-PSMA-R2 in Patients With Biochemical Relapse (BR) and Metastatic Prostate Cancer (mPCa)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Sequential Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 20, 2019

Interventions

  • Drug: 68Ga-PSMA-R2
    • radio-labelled PSMA ligand

Arms, Groups and Cohorts

  • Experimental: Phase I
    • PK and dosimetry following single dose 3 MBq/kg
  • Experimental: Phase II: Biochemically Recurrent Prostate Cancer
    • determine diagnostic effectiveness in this population
  • Experimental: Phase II: Metastatic Prostate Cancer
    • determine diagnostic effectiveness in this population

Clinical Trial Outcome Measures

Primary Measures

  • Treatment Emergent Adverse Events [Safety and tolerability]
    • Time Frame: dosing through 28 days post-dose

Secondary Measures

  • Generation of decay corrected tissue time-activity curves (TACs) from 68Ga-PSMA-R2 PET/CT images in normal organs and tumor lesions
    • Time Frame: 0 to 4 hours post-dose
  • Urinary excretion of 68Ga-PSMA-R2
    • Time Frame: 0 to 4 hours post-dose
  • Calculation of half-life of 68Ga-PSMA-R2 in blood
    • Time Frame: 0-4 hours post-dose
  • Generation of non-decay-corrected time activity curves from 68Ga-PSMA-R2 PET/CT images in normal organs and tumor lesions
    • Time Frame: 0-4 hours post-dose
  • Calculation of residence times in organs and tumor lesions of 68Ga-PSMA-R2
    • Time Frame: 0-4 hours post-dose
  • Calculation of 68Ga-PSMA-R2 absorbed dose
    • Time Frame: 0-4 hours post-dose
  • standard uptake value (SUV)
    • Time Frame: 0-4 hours post-dose
  • Calculation of patient level agreement of 68Ga-PSMA-R2 PET imaging relative to conventional techniques in prostate cancer patients
    • Time Frame: 0-4 hours post-dose
  • Calculation of and effective whole-body dose of 68Ga-PSMA-R2
    • Time Frame: 0-4 hours post-dose
  • Tumor burden measured by 68Ga-PSMA-R2 compared with standard imaging modality
    • Time Frame: 0-4 hours post-dose
  • Tumor location compared to other standard imaging modality
    • Time Frame: 0-4 hours post-dose

Participating in This Clinical Trial

Inclusion Criteria

  • Male patients, 18 years of age or older.
  • Signed and dated written informed consent by the patient prior to any study-specific procedures.
  • Histologically confirmed adenocarcinoma of the prostate.

1. Biochemical recurrence: defined as prostate specific antigen (PSA) level of ≥ 0.2 ng/mL after radical prostatectomy or PSA nadir plus 2 ng/mL after radiation therapy with corresponding CT/MRI or bone scan revealing absence of local recurrence or metastatic lesions.

OR

2. Metastatic disease: defined as both, castration-sensitive or castration-resistant mPCa (presence of at least one metastatic lymph-node, visceral metastasis and/or bone metastasis).

3. At least 2 weeks must have elapsed between last anti-cancer treatment administration and the administration of the imaging product, 68Ga-PSMA-R2.

  • Prior major surgery must be at least 12 weeks prior to study entry.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2, with a life expectancy ≥ 6 months.
  • Adequate bone marrow reserve and organ function as demonstrated by complete blood count, and biochemistry in blood and urine at Screening:
  • Hemoglobin (Hb): > 8.0 g/dL
  • Platelet count of > 50.000/mm3
  • Serum creatinine < 1.5 upper limit normal (ULN) or estimated glomerular filtration rate (eGFR) > 50 mL/min based upon The Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation [34].
  • For male patients with partners of childbearing potential, agreement to use barrier contraceptive method (condom) and to continue its use for 28 days after IP administration.

Exclusion Criteria

  • Pathological finding consistent with small cell, neuroendocrine carcinoma of the prostate or any other histologies different than adenocarcinoma.
  • Administered a radioisotope ≤ 10 physical half-lives prior to the day of PET/CT.
  • Current severe urinary incontinence, hydronephrosis, severe voiding dysfunction, or need of indwelling/condom catheters.
  • Uncontrolled pain or incompatibility that results in patient's lack of compliance with imaging procedures
  • Other known co-existing malignancies except non-melanoma skin cancer unless definitively treated and proven no evidence of recurrence for at least 5 years.
  • Patient with known incompatibility to CT scans.
  • Any evidence of severe or uncontrolled systemic or psychiatric diseases, including uncontrolled hypertension and active bleeding diatheses, which in the Investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the protocol, or active infection including human immunodeficiency virus (HIV) and untreated hepatitis B, hepatitis C. Screening for chronic conditions is not required.
  • Patients who have received any investigational agent within the last 28 days are excluded from participation in this trial.
  • Any acute toxicity due to prior chemotherapy and/or radiotherapy that has not resolved according to the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials.
  • Known allergy, hypersensitivity, or intolerance to the investigational product or its excipients.
  • Patient unlikely to comply with study procedures, restrictions and requirements and judged by the Investigator to be unsuitable for study participation.

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Advanced Accelerator Applications
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Study Director, Study Director, Advanced Accelerator Applications

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