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RecruitingLast updated: 2 February 2024

AlphaBet: This phase I/II study is seeking to determine the appropriate dose level of Radium-223 when given in addition to combination therapy (177Lu-PSMA-I&T) in people with metastatic, castration-resistant prostate cancerCombination of Radium-223 and Lutetium-177 PSMA-I&T in Men With Metastatic Castration-Resistant Prostate Cancer

Clinical summary

Summary

This study has two stages: dose escalation and dose expansion. In the dose escalation stage, eligible participants will receive 7.4 GBq of 177Lu-PSMA-I&T on Day 1 of every 6 week Cycle. Radium-223 will be administered concurrently every 6 weeks. The dose of Radium-223 will vary in dose-escalation, between 27.5 kBq/kg and 55 kBq/kg. Up to 6 Cycles will be given. The maximum tolerated dose of Radium-223 will be used during the second stage, dose expansion.

Conditions

This trial is treating patients with metastatic castration-resistant prostate cancer

Cancer

Urinary System Cancers Genitourinary

Age

People18+

Phase

I/II

Trial Acronym

AlphaBet

More information

Trial Identifiers

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Trial sponsor

Peter MacCallum Cancer Centre

Scientific Title

Combination of Radium-223 and Lutetium-177 PSMA-I&T in Men With Metastatic Castration-Resistant Prostate Cancer

Eligibility

Inclusion

  • Patient must be ≥ 18 years of age and must have provided written informed consent.
  • Histologically or cytologically confirmed adenocarcinoma of the prostate, OR unequivocal diagnosis of metastatic prostate cancer. (i.e. involving bone or pelvic lymph nodes or para-aortic lymph nodes) with an elevated serum PSA.
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
  • Patients must have progressed on ≥ 1 second-generation AR-targeted agent (e.g., enzalutamide, abiraterone, apalutamide, or darolutamide).
  • Patients must have progressive disease for study entry. PCWG3 defines this as any one of the following:

    • PSA progression: minimum of two rising PSA values from a baseline measurement with an interval of ≥ 1 week between each measurement.
    • Soft tissue progression as per RECIST 1.1 criteria
    • Bone progression: ≥ 2 new lesions on bone scan
    • Symptomatic progression eg. Bone pain
  • At least three weeks since receiving anti-cancer treatment (other than ADT), the completion of surgery or radiotherapy prior to registration.
  • Prior surgical orchiectomy or chemical castration maintained on luteinizing hormone-releasing hormone (LHRH) analogue (agonist or antagonist).
  • Serum testosterone levels ≤ 1.75nmol/L (≤ 50ng/dL) within 28 days before registration.
  • Significant PSMA avidity on PSMA PET/CT, defined as a minimum uptake of SUVmax 20 at a site of disease, and SUVmax >10 at sites of measurable disease >10mm (unless subject to factors explaining a lower uptake, e.g. respiratory motion, reconstruction artefact).
  • ≥ 2 bone metastases must be present on bone scintigraphy which have not been previously treated with radiotherapy.
  • No contraindication to treatment with a bone antiresorptive agent such as denosumab or zoledronic acid.
  • Patients must have adequate bone marrow, hepatic and renal function documented within 28 days prior to registration, defined as:

    • Haemoglobin ≥ 90 g/L independent of transfusions (no red blood cell transfusion in last four weeks)
    • Absolute neutrophil count ≥ 1.5x10^9/L
    • Platelets ≥ 150 x10^9/L
    • Total bilirubin ≤ 1.5 x upper limit of normal (ULN) except for patients with known Gilbert's syndrome, where this applies for the unconjugated bilirubin component.
    • Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 x ULN if there is no evidence of liver metastasis or ≤ 5 x ULN in the presence of liver metastases
    • Albumin ≥ 25 g/L
    • Adequate renal function: patients must have a creatinine clearance estimated of ≥ 40 mL/min using the Cockcroft Gault equation
  • Sexually active patients are willing to use medically acceptable forms of barrier contraception.
  • Willing to undergo biopsies, if disease is considered accessible and biopsy is feasible.
  • Willing and able to comply with all study requirements, including all treatments and the timing and nature of all required assessments.

Exclusion

Patients who meet any of the following criteria will be excluded from study entry:

  • Superscan on Bone scan (WBBS) or diffuse marrow involvement on PSMA PET/CT
  • Prior treatment with 223Ra or 177Lu-PSMA.
  • Has received more than one previous line of chemotherapy for the treatment of metastatic prostate cancer.
  • Sites of discordant FDG-positive disease defined by minimal PSMA-expression and no uptake on WBBS (for bone metastases).
  • Other malignancies within the previous 2 years other than basal cell or squamous cell carcinomas of skin or other cancers that are unlikely to recur within 24 months.
  • Symptomatic brain metastases or leptomeningeal metastases.
  • Patients with symptomatic or impending cord compression unless appropriately treated beforehand and clinically stable for ≥ four weeks.
  • Concurrent illness, including severe infection that may jeopardise the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety.

Inclusion

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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