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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04430192




Registration number
NCT04430192
Ethics application status
Date submitted
21/05/2020
Date registered
12/06/2020
Date last updated
7/08/2020

Titles & IDs
Public title
Dosimetry, Safety and Potential Benefit of 177Lu-PSMA-617 Prior to Prostatectomy
Scientific 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
Secondary ID [1] 0 0
19_245
Universal Trial Number (UTN)
Trial acronym
LuTectomy
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostatic Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - 177Lu-PSMA-617

Experimental: 177Lu-PSMA-617 followed by prostatectomy - 177Lu-PSMA-617 followed by prostatectomy


Treatment: Drugs: 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.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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)
Timepoint [1] 0 0
Determined using imaging at 4, 24 and 96 hrs after administration of Lu-PSMA
Secondary outcome [1] 0 0
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)
Timepoint [1] 0 0
6 weeks following final administration of Lu-PSMA
Secondary outcome [2] 0 0
To evaluate the biochemical response to therapy - PSA response
Timepoint [2] 0 0
6 weeks following final administration of Lu-PSMA
Secondary outcome [3] 0 0
To evaluate pathologic response in the prostate following prostatectomy - Pathological response (complete response, minimal residual disease)
Timepoint [3] 0 0
After prostatectomy, approximately 6 weeks from final Lu-PSMA administration
Secondary outcome [4] 0 0
To evaluate toxicity of Lu-PSMA - Assessment of toxicity of Lu-PSMA using Common Terminology Criteria for Adverse Events (CTCAE) v5
Timepoint [4] 0 0
Until 8 weeks after prostatectomy
Secondary outcome [5] 0 0
To evaluate the surgical safety of prostatectomy following Lu-PSMA - Surgical safety will be assessed using using the Clavien-Dindo classification of surgical complications
Timepoint [5] 0 0
Until 8 weeks after prostatectomy
Secondary outcome [6] 0 0
To evaluate overall health-related Quality of Life (QoL) - QoL indices will be scored using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire
Timepoint [6] 0 0
baseline, immediately before 2nd cycle Lu-PSMA, immediately before surgery, 8 weeks post surgery, annually up to 3 years
Secondary outcome [7] 0 0
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
Timepoint [7] 0 0
baseline, immediately before 2nd cycle Lu-PSMA, immediately before surgery, 8 weeks post surgery, annually up to 3 years
Secondary outcome [8] 0 0
To evaluate patient function and bother after prostatectomy - Indices will be scored using the Expanded Prostate Cancer Index Composite (EPIC)-26 questionnaire
Timepoint [8] 0 0
baseline, immediately before 2nd cycle Lu-PSMA, immediately before surgery, 8 weeks post surgery, annually up to 3 years

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1/Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 0 0
3000 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Peter MacCallum Cancer Centre, Australia
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Movember Foundation
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Medical Research Future Fund (MRFF)
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Commercial sector/Industry
Name [3] 0 0
Endocyte
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
E.J. Whitten Foundation Prostate Cancer Research Centre
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

Summary
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)
Trial website
https://clinicaltrials.gov/show/NCT04430192
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Declan Murphy
Address 0 0
Peter MacCallum Cancer Centre, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Annette M Van Der Heyden
Address 0 0
Country 0 0
Phone 0 0
+613 8559 5000
Fax 0 0
Email 0 0
annette.vanderheyden@petermac.org
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04430192