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RecruitingLast updated: 13 February 2024

POPSTAR II: This study is trying to understand whether radiation therapy plus a form of systemic therapy called radionuclide therapy is more effective than radiation therapy alone in people with oligometastatic prostate cancer who are undergoing PSMA positron emission tomography (PET) stagingLu-PSMA for Oligometastatic Prostate Cancer Treated With STereotactic Ablative Radiotherapy, a Randomised Phase II Parallel Cohort Trial

Clinical summary

Summary

Eligible participants will be randomly allocated to one of two treatment arms. In Arm 1, participants will receive Stereotactic Ablative Body Radiotherapy (SABR) alone. They will receive 1-3 fractions of SABR to all sites of their disease. In Arm 2, participants will receive SABR plus 2 cycles of Lutetium-177 (177Lu)-PSMA. 177Lu-PSMA is a type of systemic therapy called radionuclide, and is comprised of a small molecule inhibitor of PSMA that binds to PSMA receptors and then emits radiation and damages the cancer cells. Participants in this arm will receive 2 cycles of 177Lu-PSMA with 1-3 fractions of SABR to all sites of their disease between cycles 1 and 2.

Conditions

This trial is treating patients with oligometastatic prostate cancer

Cancer

Urinary System Cancers Genitourinary

Age

People18+

Phase

II

Trial Acronym

POPSTAR II

More information

Trial Identifiers

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Trial sponsor

Peter MacCallum Cancer Centre

Scientific Title

Lu-PSMA for Oligometastatic Prostate Cancer Treated With STereotactic Ablative Radiotherapy, a Randomised Phase II Parallel Cohort Trial

Eligibility

Inclusion

  1. Male aged 18 years or older at screening
  2. Patient has provided written informed consent
  3. Histologically confirmed prostate adenocarcinoma w
  4. Prior definitive treatment of the primary with either curative intent radiotherapy and/or surgery
  5. Patient has 1-5 sites of nodal or bony metastases on 68Ga-PSMA or 18F-DCFPyL PET/CT with a score of 4 or 5 as defined by the E-PSMA criteria
  6. At least one site of disease with SUVmax twice the SUVmax of liver on PSMA PET (Ga-68 PSMA 11 or F-18 DCFPYL tracers only)
  7. Adequate haematological function as defined by:

    • Absolute neutrophil count (ANC) ≥1.5 x 109/L
    • Platelet count >150x 109/L
    • Haemoglobin ≥100 g/L
    • Creatinine Clearance ≥ 40mL/min (Cockcroft-Gault formula)
  8. Assessed as suitable for SABR by a radiation oncologist
  9. Patients must agree to use an adequate method of contraception
  10. Have a performance status of 0-1 on the ECOG Performance Scale

Exclusion

  1. Prior systemic therapy, radiation therapy, or surgery for metastatic prostate cancer. Prior ADT is allowed but ADT within 6 months of screening for the study is not allowed. If patients have received prior ADT, serum testosterone levels must be above the lower limit of normal
  2. No sites of PSMA negative metastatic disease evident on CT/bone scan
  3. Any visceral (AJCCC M1c) metastases
  4. Symptomatic cord compression, or clinical or imaging findings concerning for impending cord compression
  5. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating Investigator
  6. Has a known additional malignancy that is progressing or required active treatment in the last 2 years Note: Basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer or carcinoma in situ such as breast cancer in situ that has undergone potentially curative therapy are not excluded.

Inclusion

  • 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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