Summary

for males ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion
Thomas Hope

Description

Summary

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).

Official Title

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)

Keywords

Prostate Cancer Metastatic Prostatic Neoplasms 68Ga-PSMA-R2

Eligibility

You can join if…

Open to males ages 18 years and up

  • 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.
  • 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

  1. 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).
  2. At least 2 weeks must have elapsed between last anti-cancer treatment administration and the administration of the imaging product, 68Ga-PSMA-R2.
  3. Prior major surgery must be at least 12 weeks prior to study entry.
  4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2, with a life expectancy ≥ 6 months.
  5. Adequate bone marrow reserve and organ function as demonstrated by complete blood count, and biochemistry in blood and urine at Screening:
  6. Hemoglobin (Hb): > 8.0 g/dL
  7. Platelet count of > 50.000/mm3
  8. 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].
  9. 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.

You CAN'T join if...

  • 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.

Locations

  • University of California, San Francisco (UCSF) in progress, not accepting new patients
    San Francisco California 94158 United States
  • Pheonix Molecular Imaging Center in progress, not accepting new patients
    Phoenix Arizona 85040 United States

Lead Scientist

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Advanced Accelerator Applications
ID
NCT03490032
Phase
Phase 1/2
Study Type
Interventional
Last Updated