Dosimetry, Safety and Potential Benefit of 177Lu-PSMA-617 Prior to Prostatectomy (LuTectomy)
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|ClinicalTrials.gov Identifier: NCT04430192|
Recruitment Status : Active, not recruiting
First Posted : June 12, 2020
Last Update Posted : May 10, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Prostatic Neoplasms||Drug: 177Lu-PSMA-617||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Study of the Dosimetry, Safety and Potential Benefit of 177Lu-PSMA-617 Radionuclide Therapy Prior to Radical Prostatectomy in Men With High-risk Localised Prostate Cancer|
|Actual Study Start Date :||August 6, 2020|
|Estimated Primary Completion Date :||August 7, 2022|
|Estimated Study Completion Date :||June 30, 2023|
Experimental: 177Lu-PSMA-617 followed by prostatectomy
177Lu-PSMA-617 followed by prostatectomy
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.
- 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 [ Time Frame: Determined using imaging at 4, 24 and 96 hrs after administration of Lu-PSMA ]Establishing the absorbed radiation dose in the prostate and involved lymph nodes (Gy)
- To evaluate the imaging response to therapy using PSMA-PET [ Time Frame: 6 weeks following final administration of Lu-PSMA ]PSMA PET response to therapy (complete metabolic response, partial metabolic response, stable metabolic disease, progressive metabolic disease)
- To evaluate the biochemical response to therapy [ Time Frame: 6 weeks following final administration of Lu-PSMA ]PSA response
- To evaluate pathologic response in the prostate following prostatectomy [ Time Frame: After prostatectomy, approximately 6 weeks from final Lu-PSMA administration ]Pathological response (complete response, minimal residual disease)
- To evaluate toxicity of Lu-PSMA [ Time Frame: Until 8 weeks after prostatectomy ]Assessment of toxicity of Lu-PSMA using Common Terminology Criteria for Adverse Events (CTCAE) v5
- To evaluate the surgical safety of prostatectomy following Lu-PSMA [ Time Frame: Until 8 weeks after prostatectomy ]Surgical safety will be assessed using using the Clavien-Dindo classification of surgical complications
- To evaluate overall health-related Quality of Life (QoL) [ Time Frame: baseline, immediately before 2nd cycle Lu-PSMA, immediately before surgery, 8 weeks post surgery, annually up to 3 years ]QoL indices will be scored using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire
- To evaluate prostate cancer health-related Quality of Life (QoL) [ Time Frame: baseline, immediately before 2nd cycle Lu-PSMA, immediately before surgery, 8 weeks post surgery, annually up to 3 years ]QoL indices will be scored using European Organisation for Research and Treatment of Cancer (EORTC) QLQ-PR25 questionnaire
- To evaluate patient function and bother after prostatectomy [ Time Frame: baseline, immediately before 2nd cycle Lu-PSMA, immediately before surgery, 8 weeks post surgery, annually up to 3 years ]Indices will be scored using the Expanded Prostate Cancer Index Composite (EPIC)-26 questionnaire
- To determine the time to biochemical recurrence (BCR) [PSA>0.2 ng/mL post-RP] [ Time Frame: To be determined as it is an exploratory endpoint up to 3 years ]Biochemical recurrence (BCR) will be measured from the time of surgery to the first rise of the PSA to ≥0.2 ng/mL
- To determine the relationship between PSMA PET imaging parameters and absorbed dose [ Time Frame: baseline PSMA PET within 45 days of Lu-PSMA administration ]Determination of the relationship between screening PSMA PET imaging parameters including molecular tumour volume parameters and absorbed dose in the prostate and involved lymph nodes
- To identify tissue and blood and serum biomarkers associated with clinical outcomes [ Time Frame: To be determined as it is an exploratory endpoint up to 3 years ]Determination of relevant predictive biomarkers associated with treatment outcomes and response
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Male|
|Accepts Healthy Volunteers:||No|
- Patient has provided written informed consent.
- Male patient aged 18 or over at the time of screening
- Histologically confirmed adenocarcinoma of the prostate, in a patient scheduled for RP and PLND with curative intent
High or high-intermediate risk localised or locoregional prostate cancer (HRCaP) by European Association of Urology (EAU) criteria, including any of the following:
- PSA > 20 ng/mL
- ISUP grade group 3-5
- Clinical T-stage by digital rectal examination (DRE) of T2c or higher
- N1 disease (involvement of lymph nodes at or below the bifurcation of the common iliac arteries)
- defined radiologically (CT/ MRI, or PSMA PET).
- High PSMA avidity on 68Ga-PSMA PET/CT, defined as an SUVmax of ≥ 20
- Normal baseline haematological function; haemoglobin 13.5-17.5g/dl), total white blood cell count (4-11 x 109/l), platelets (150-400 x 109/l), neutrophils (2-7.5 x 109/l) and lymphocytes (1-4 x 109/l)
- Normal baseline serum biochemistry; sodium 135-145 nmol/l, potassium 3.5-5 nmol/l, chloride 98-108 nmol/l, urea 3-9.2 nmol/l, creatinine 60-120μmol/l
- Willing and able to comply with all study requirements including all treatments and required assessments including follow up
- Prostate cancer with significant neuroendocrine or other rare variant pathology
- Prior treatment for prostate cancer including radiotherapy and/or androgen deprivation therapy.
- Evidence of metastatic disease involving bone, viscera, or lymph nodes superior to the common iliac bifurcation based on CT, MRI, WBBS or PSMA PET/CT.
- Renal impairment [GFR < 60mL/min].
- Sjogren's syndrome.
- A history of 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04430192
|Peter MacCallum Cancer Centre|
|Melbourne, Victoria, Australia, 3000|
|Principal Investigator:||Declan Murphy||Peter MacCallum Cancer Centre, Australia|
|Principal Investigator:||Michael S Hofman||Peter MacCallum Cancer Centre, Australia|
|Principal Investigator:||John Violet||Peter MacCallum Cancer Centre, Australia|
|Responsible Party:||Peter MacCallum Cancer Centre, Australia|
|Other Study ID Numbers:||
|First Posted:||June 12, 2020 Key Record Dates|
|Last Update Posted:||May 10, 2022|
|Last Verified:||May 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
prostate specific membrane antigen
Genital Neoplasms, Male
Neoplasms by Site
Genital Diseases, Male
Male Urogenital Diseases
Molecular Mechanisms of Pharmacological Action