64Cu-Sar-Bispsma Positron Emission Tomography: a Phase 3 Study of Participants with Biochemical Recurrence of Prostate Cancer

CB

Clinton Bahler, MD

Principal Investigator

Status: Enrolling By Invitation Ages: 18 Years - 100 Years Gender: Male Phase: 3 2 Locations

Brief Description

The aim for this study is to investigate the ability of 64Cu-SAR-bisPSMA PET/CT to detect recurrence of prostate cancer

THIS STUDY IS ENROLLING BY INVITATION ONLY - Consistent with most oncology trials, patients are not actively “recruited,” but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit. Occasionally, a patient may be a self-referral or physician referral, but are still screened for appropriate clinical trials at the time of their routine clinic visit. PI and staff may send copies of relevant consent forms to these patients to look over prior to actually consenting or enrolling them. This may take place at the patient's visit at which the consent is presented or the patient's next visit to the outpatient hematology/oncology clinic. 

Interested in participating?  For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:

IU Clinical Trials Office 

Email: iutrials@iu.edu 

Phone: (317) 278-5632

Detailed Description

DrugStudy Drug: 64Cu-SAR-bisPSMA

  • All Patients will receive a single administration, a bolus injection of 200MBq 64Cu-SAR-bisPSMA

Eligibility of study

Inclusion Criteria:

  1. At least 18 years of age.
  2. Signed informed consent.
  3. Life expectancy ≥ 6 months as determined by the Investigator.
  4. Histologically confirmed adenocarcinoma of prostate per original diagnosis and completed subsequent definitive therapy.
  5. Participant potentially eligible for salvage therapy with curative intent.
  6. PSA level after definitive therapy:
    1. Post-radical prostatectomy: Detectable or rising PSA that is ≥ 0.2 ng/mL with a confirmatory PSA ≥ 0.2 ng/mL (per AUA recommendation) or
    2. Post-radiation therapy, cryotherapy, or brachytherapy: Increase in PSA level that is elevated by ≥ 2 ng/mL above the nadir (per ASTRO-Phoenix consensus definition).
  7. Participant willing to undergo biopsy of a 64Cu-SAR-bisPSMA PET-positive lesion for histological confirmation of PC, where this is safe and feasible.
  8. An Eastern Cooperative Oncology performance status of 0-2.

Exclusion Criteria:

  1. Participants who received investigational agent within 5 biological half-lives prior to Day 1.
  2. Participants administered any high energy (>300 KeV) gamma-emitting radioisotope within 5 physical half-lives prior to Day 1.
  3. Previous systemic therapy for PC (with the exception of neoadjuvant and adjuvant systemic therapy as part of the definitive therapy).
  4. Ongoing treatment or treatment within 6 months of Day 1 with any systemic therapy (e.g. any investigational therapy, androgen-deprivation therapy, antiandrogen, gonadotropin-releasing hormone, luteinizing hormone-releasing hormone agonist or antagonist, chemotherapy, immunotherapy or radiotherapy) for PC.
  5. Known or expected hypersensitivity to 64Cu-SAR-bisPSMA or any of its components.
  6. Any serious medical condition or extenuating circumstance (including receiving the investigational product or not capable of having a PET scan) which the investigator feels may interfere with the procedures or evaluations of the study.

Interested in participating?

Enrollment in IU School of Medicine clinical trials is managed through our All IN for Health program. Many studies only accept people who are part of an invited group. Visit allinforhealth.info to connect with the study team, or contact your doctor to see if you are eligible.