AzTrials
AzTrials

Prostatic NeoplasmsPhase 1/2LuTectomyNCT04430192

Dosimetry, Safety and Potential Benefit of 177Lu-PSMA-617 Prior to Prostatectomy

A Phase 1/2 study testing 177Lu-PSMA-617 in people with Prostatic Neoplasms, run by Peter MacCallum Cancer Centre, Australia at 1 site in Australia.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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) Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostatic Neoplasms
What is being tested?
177Lu-PSMA-617
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteAustralia
Study dates
6 Aug 2020to 30 Aug 2025
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 13Show fewer
  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000

Other trials in Australia

About this study

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

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)

Read the 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).

Being tested
177Lu-PSMA-617
Keywords
177Lu-PSMA, Prostate Cancer, Radionuclide Therapy, Theranostics, prostate specific membrane antigen
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 177Lu-PSMA-617Drug

    Also called 177Lu-PSMA, [177Lu]Lu-PSMA-617, Lu-PSMA

    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.

Study groups in NCT04430192
Study groupRoleWhat they receive
177Lu-PSMA-617 followed by prostatectomyExperimental177Lu-PSMA-617 followed by prostatectomy
Receives: Drug: 177Lu-PSMA-617

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Establishing the absorbed radiation dose in the prostate and involved lymph nodes (Gy)

    Measured: Determined using imaging at 4, 24 and 96 hrs after administration of Lu-PSMA

Secondary outcomes (8)

  1. 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)

    Measured: 6 weeks following final administration of Lu-PSMA

  2. To evaluate the biochemical response to therapy

    PSA response

    Measured: 6 weeks following final administration of Lu-PSMA

  3. To evaluate pathologic response in the prostate following prostatectomy

    Pathological response (complete response, minimal residual disease)

    Measured: After prostatectomy, approximately 6 weeks from final Lu-PSMA administration

  4. To evaluate toxicity of Lu-PSMA

    Assessment of toxicity of Lu-PSMA using Common Terminology Criteria for Adverse Events (CTCAE) v5

    Measured: Until 8 weeks after prostatectomy

  5. To evaluate the surgical safety of prostatectomy following Lu-PSMA

    Surgical safety will be assessed using using the Clavien-Dindo classification of surgical complications

    Measured: Until 8 weeks after prostatectomy

  6. 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

    Measured: baseline, immediately before 2nd cycle Lu-PSMA, immediately before surgery, 8 weeks post surgery, annually up to 3 years

  7. 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

    Measured: baseline, immediately before 2nd cycle Lu-PSMA, immediately before surgery, 8 weeks post surgery, annually up to 3 years

  8. To evaluate patient function and bother after prostatectomy

    Indices will be scored using the Expanded Prostate Cancer Index Composite (EPIC)-26 questionnaire

    Measured: baseline, immediately before 2nd cycle Lu-PSMA, immediately before surgery, 8 weeks post surgery, annually up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2020
  2. Study start6 Aug 2020
  3. Primary completion22 Dec 2022
  4. Study completion30 Aug 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04430192
Sponsor's protocol ID
19_245
Acronym
LuTectomy
Status last verified
Nov 2024
First submitted
21 May 2020
Last updated
8 Nov 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Eapen RS, Buteau JP, Jackson P, Mitchell C, Oon SF, Alghazo O, McIntosh L, Dhiantravan N, Scalzo MJ, O'Brien J, Sandhu S, Azad AA, Williams SG, Sharma G, Haskali MB, Bressel M, Chen K, Jenjitranant P, McVey A, Moon D, Lawrentschuk N, Neeson PJ, Murphy DG, Hofman MS. Administering [177Lu]Lu-PSMA-617 Prior to Radical Prostatectomy in Men with High-risk Localised Prostate Cancer (LuTectomy): A Single-centre, Single-arm, Phase 1/2 Study. Eur Urol. 2024 Mar;85(3):217-226. doi: 10.1016/j.eururo.2023.08.026. Epub 2023 Oct 26.

    PubMed 37891072

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing 177Lu-PSMA-617 in people with Prostatic Neoplasms, run by Peter MacCallum Cancer Centre, Australia at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 8 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04430192, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in