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Trial record 2 of 4 for:    VIOLET | Prostate Cancer
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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 : August 21, 2023
Sponsor:
Collaborators:
Movember Foundation
Medical Research Future Fund
Endocyte
E.J. Whitten Foundation Prostate Cancer Research Centre
Information provided by (Responsible Party):
Peter MacCallum Cancer Centre, Australia

Study Description
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Brief Summary:
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)

Condition or disease Intervention/treatment Phase
Prostatic Neoplasms Drug: 177Lu-PSMA-617 Phase 1 Phase 2

Detailed Description:
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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Primary Completion Date : December 22, 2022
Estimated Study Completion Date : December 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: 177Lu-PSMA-617 followed by prostatectomy
177Lu-PSMA-617 followed by prostatectomy
 Drug: 177Lu-PSMA-617
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.
Other Names:
  • 177Lu-PSMA
  • [177Lu]Lu-PSMA-617
  • Lu-PSMA


Outcome Measures
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Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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)

  2. To evaluate the biochemical response to therapy [ Time Frame: 6 weeks following final administration of Lu-PSMA ]
    PSA response

  3. 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)

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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


Other Outcome Measures:
  1. 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

  2. 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

  3. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Australia, Victoria
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia, 3000
Sponsors and Collaborators
Peter MacCallum Cancer Centre, Australia
Movember Foundation
Medical Research Future Fund
Endocyte
E.J. Whitten Foundation Prostate Cancer Research Centre
Investigators
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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
More Information
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Responsible Party: Peter MacCallum Cancer Centre, Australia
ClinicalTrials.gov Identifier: NCT04430192    
Other Study ID Numbers: 19_245
First Posted: June 12, 2020    Key Record Dates
Last Update Posted: August 21, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Peter MacCallum Cancer Centre, Australia:
177Lu-PSMA
Prostate Cancer
Radionuclide Therapy
Theranostics
prostate specific membrane antigen
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Genital Diseases, Male
 Genital Diseases
Urogenital Diseases
Male Urogenital Diseases
Pluvicto
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action