This clinical trial will evaluate the dosimetry, efficacy and toxicity of Lu-PSMA in men with high PSMA-expressing high-risk localized or locoregional advanced prostate cancer (HRCaP) undergoing radical prostatectomy (RP) and pelvic lymph node dissection (PLND)
This open label, phase I/II non-randomised clinical trial will evaluate the dosimetry, efficacy and toxicity of Lu-PSMA in men with high PSMA-expressing high-risk localized or locoregional advanced prostate cancer (HRCaP) undergoing radical prostatectomy (RP) and pelvic lymph node dissection (PLND). Patients will receive one or two cycles of 177Lu-PSMA followed by surgery. The primary objective is to determine the radiation absorbed dose in the prostate and involved lymph nodes. Secondary objectives include evaluating imaging response to therapy using PSMA-PET, biochemical response, pathological response, adverse effects of Lu-PSMA and surgical safety, and health-related Quality of Life (QoL).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Patients 1-10 will be given 5GBq of 177Lu-PSMA. Patients 11-20 will be given 2 cycles of 5GBq of 177Lu-PSMA, separated by 6 weeks.
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
To determine the radiation absorbed dose in the prostate and involved lymph nodes following one or two administrations of Lu-PSMA in men with HRCaP prior to radical prostatectomy
Establishing the absorbed radiation dose in the prostate and involved lymph nodes (Gy)
Time frame: Determined using imaging at 4, 24 and 96 hrs after administration of Lu-PSMA
To evaluate the imaging response to therapy using PSMA-PET
PSMA PET response to therapy (complete metabolic response, partial metabolic response, stable metabolic disease, progressive metabolic disease)
Time frame: 6 weeks following final administration of Lu-PSMA
To evaluate the biochemical response to therapy
PSA response
Time frame: 6 weeks following final administration of Lu-PSMA
To evaluate pathologic response in the prostate following prostatectomy
Pathological response (complete response, minimal residual disease)
Time frame: After prostatectomy, approximately 6 weeks from final Lu-PSMA administration
To evaluate toxicity of Lu-PSMA
Assessment of toxicity of Lu-PSMA using Common Terminology Criteria for Adverse Events (CTCAE) v5
Time frame: Until 8 weeks after prostatectomy
To evaluate the surgical safety of prostatectomy following Lu-PSMA
Surgical safety will be assessed using using the Clavien-Dindo classification of surgical complications
Time frame: Until 8 weeks after prostatectomy
To evaluate overall health-related Quality of Life (QoL)
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QoL indices will be scored using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire
Time frame: baseline, immediately before 2nd cycle Lu-PSMA, immediately before surgery, 8 weeks post surgery, annually up to 3 years
To evaluate prostate cancer health-related Quality of Life (QoL)
QoL indices will be scored using European Organisation for Research and Treatment of Cancer (EORTC) QLQ-PR25 questionnaire
Time frame: baseline, immediately before 2nd cycle Lu-PSMA, immediately before surgery, 8 weeks post surgery, annually up to 3 years
To evaluate patient function and bother after prostatectomy
Indices will be scored using the Expanded Prostate Cancer Index Composite (EPIC)-26 questionnaire
Time frame: baseline, immediately before 2nd cycle Lu-PSMA, immediately before surgery, 8 weeks post surgery, annually up to 3 years