In Men With Metastatic Prostate Cancer, What is the Safety and Benefit of Lutetium-177 PSMA Radio… (NCT04343885) | Clinical Trial Compass
Active — Not RecruitingPhase 2
In Men With Metastatic Prostate Cancer, What is the Safety and Benefit of Lutetium-177 PSMA Radionuclide Treatment in Addition to Chemotherapy
Australia130 participantsStarted 2020-04-21
Plain-language summary
This phase 2 randomised clinical trial will compare the effectiveness of Lu-PSMA therapy followed by docetaxel chemotherapy versus docetaxel chemotherapy on its own in patients with newly-diagnosed high-volume metastatic hormone-naive prostate cancer (mHNPC).
Who can participate
Age range18 Years
SexMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Patient has provided written informed consent
✓. Male aged 18 years or older at screening
✓. Prostate cancer diagnosed within 12 weeks of commencement of screening
✓. Histologically or cytologically confirmed adenocarcinoma of the prostate without significant neuroendocrine differentiation or small cell histology OR metastatic disease typical of prostate cancer (i.e. involving bone or pelvic lymph nodes or para-aortic lymph nodes) with a rising serum PSA
✓. Evidence of metastatic disease on CT and/or bone scan
✓. PSA \> 10ng/ml prior to commencement of medical ADT or surgical orchidectomy
✓. Adequate haematological, renal and hepatic functions as defined by:
✓. Have a performance status of 0-2 on the ECOG Performance Scale (see Appendix 1)
Exclusion criteria
✕. Any prior pharmacotherapy, radiation therapy, or surgery for metastatic prostate cancer. The following exceptions are permitted:
✕. Symptomatic cord compression, or clinical or imaging findings concerning for impending cord compression
✕. Central nervous system metastases
✕. Patients with Sjogren's syndrome
What they're measuring
1
Undetectable prostate specific antigen (PSA) rate at 12 months after commencement of protocol therapy
Timeframe: Upto 32 months assuming 18 months to complete recruitment, a maximum of 1.6 months from consent to commencement of treatment for last patient and then 12 months from commencement of treatment for last patient.
. 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
✕. Prior diagnosis of another cancer that was:
✕. Significant PSMA avidity on 68Ga-PSMA PET/CT, defined after central review as a minimum uptake of SUVmax 15 at a site of disease
✕. High-volume metastatic disease on 68Ga-PSMA PET/CT defined as visceral metastases or ≥ 4 bone metastases with ≥ 1 outside the vertebral column and pelvis (extra-axial skeleton)