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External Beam Therapy With Theranostic Radioligand Therapy for Oligometastatic Prostate Cancer (ProstACT TARGET)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05146973
Recruitment Status : Recruiting
First Posted : December 7, 2021
Last Update Posted : February 27, 2023
Sponsor:
Information provided by (Responsible Party):
Telix International Pty Ltd

Study Description
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Brief Summary:
This is a phase II trial to evaluate the therapeutic efficacy of a radiolabelled PSMA-targeting antibody, 177Lu-TLX591, given in combination with external beam radiation therapy (EBRT) in patients with biochemically recurrent, oligometastatic, PSMA-expressing prostate cancer. TLX591 is being developed as a PSMA-targeting antibody to be radiolabelled with a therapeutic radiosotope for the treatment of PSMA-expressing tumours.

Condition or disease Intervention/treatment Phase
Prostate Cancer Biological: 177Lu-DOTA-TLX591 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single Arm, Phase 2 Trial of External Beam Radiation Therapy (EBRT) in Combination With 177Lu-DOTA-TLX591-CHO in Patients With Biochemically Recurrent Oligometastatic, Prostate Specific Membrane Antigen-Expressing Prostate Cancer
Actual Study Start Date : August 30, 2022
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : June 30, 2025

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: Single administration of 177Lu-DOTA-TLX591
Two single IV infusions of 76 mCi (2.8 GBq) each (equivalent to a 45 mCi/m2 administered activity in a standard 1.7m2 individual) of 177Lu-DOTA-TLX591, given 14 days apart.
 Biological: 177Lu-DOTA-TLX591
TLX591, a monoclonal antibody conjugated with a DOTA chelator and radiolabelled with 177Lu (177Lu-DOTA-TLX591)


Outcome Measures
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Primary Outcome Measures :
  1. To determine Prostate Specific Antigen Progression Free Survival (PSA PFS) [ Time Frame: Through study completion, up to 2 years ]
    The time from enrolment to time of PSA increase greater than 25%


Eligibility Criteria
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Information from the National Library of Medicine

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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:

  • Signed Informed Consent Form
  • Male, aged ≥ 18 years
  • Estimated life expectancy of at least 6 months
  • Eastern Cooperative Oncology Group (ECOG) score 0 - 2
  • Biopsy proven prostate adenocarcinoma with Gleason Score 7 or more at primary presentation
  • Previous Radical Prostatectomy (RP) with curative intent (+/- post-operative radiotherapy to prostate bed)
  • Biochemical relapse, as defined by EAU-ESTRO-SIOG Guidelines (serum PSA > 0.2 ng/mL, confirmed by repeat measurements)
  • PSMA-ligand avid pelvic nodal disease on PSMA-ligand PET/CT, with visualised disease confined to the pelvis with or without evidence of PSMA-avid disease in the prostate bed
  • At least one pelvic nodal lesion ≥ 5 mm in the greatest dimension. SUVmax > 9 in enlarged nodes; SUVmax > 3 in nodes 5 mm or less
  • Oligometastatic disease as defined by ≤ 5 metastatic lymph nodes
  • Metastatic lymph nodes not beyond the aortic bifurcation
  • Non-castrate levels of testosterone (> 20 ng/dL)
  • Chemotherapy naïve
  • Adequate renal function: Cr Cl ≥ 40 mL/min (determined by Cockcroft-Gault formula)
  • Adequate bone marrow function: Hb > 90 g/L; platelets > 100 x 109/L; neutrophils > 1.5 x 109/L
  • Adequate liver function: bilirubin < 1.5 x upper limit of normal (ULN); AST, ALT, ALP < 2 x ULN; albumin > 30 g/L
  • Willing and able to comply with all trial requirements, including all treatments and pre- and post-treatment assessments
  • Able to commence treatment within 28 days of enrolment

Exclusion Criteria:

  • Previous external beam radiotherapy to pelvis for other malignancies or medical conditions (except for post-operative prostate bed radiotherapy for prostate cancer)
  • Androgen deprivation therapy within 12 months of trial screening
  • Known androgen deficiency
  • Bone or visceral metastases
  • Lymph node metastases above the aortic bifurcation
  • Contraindications to pelvic irradiation as determined by Investigator (e.g., chronic inflammatory bowel disease)
  • At increased risk of haemorrhage, or recent history of a thrombotic event (e.g., Deep Vein Thrombosis [DVT]/Pulmonary Embolism [PE]) and/or are using long-term anti-coagulant or anti-platelet agents)
  • Known hypersensitivity to any isotope of lutetium (Lu) in any chemical form, or any isotope used in PSMA imaging
  • Contraindication to intravenous contrast
  • Evidence of urinary tract stricture, or significant urinary/faecal incontinence Presence of active infection at time of screening, or history of serious infection within the previous 4 weeks
  • History of any malignancy other than prostate cancer within 5 years of enrolment (excluding localised non-melanoma skin cancers)
  • Any uncontrolled significant medical, psychiatric, or surgical condition (e.g., active infection, unstable angina pectoris, cardiac arrhythmia, poorly controlled type 2 diabetes, uncontrolled congestive heart failure, pulmonary disease), or laboratory findings that, in the opinion of the Investigator, may jeopardise the participant's safety or that would limit compliance with the treatment and assessment requirements of the trial
  • Any cognitive impairment or other condition that may render the participant unable to adequately understand the requirements, nature, and possible consequences of the trial.
  • Intention to father children within a timeframe corresponding with the duration of the allocated treatment regime plus 12 weeks.
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): NCT05146973


Contacts
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Contact: Julie Gisbon 317-588-9700 julie.gibson@telixpharma.com
Contact: Charlotte Hawkins, PhD 317-588-9700 charlotte.hawkins@telixpharma.com

Locations
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Australia, New South Wales
GenesisCare North Shore Recruiting
St Leonards, New South Wales, Australia
Contact: Laurence Krieger       laurence_krieger@hotmail.com   
Australia, Western Australia
GenesisCare Murdoch Recruiting
Perth, Western Australia, Australia, 6150
Contact: Nat Lenzo, MD    +61 02 8236 3300    nat.lenzo@genesiscare.com   
Australia
GenesisCare St Andrews Recruiting
Adelaide, Australia, 5000
GenesisCare Tugun Recruiting
Tugun, Australia, 4225
Contact: David Christie, MD         
Sponsors and Collaborators
Telix International Pty Ltd
More Information
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Responsible Party: Telix International Pty Ltd
ClinicalTrials.gov Identifier: NCT05146973    
Other Study ID Numbers: ProstACT TARGET
First Posted: December 7, 2021    Key Record Dates
Last Update Posted: February 27, 2023
Last Verified: November 2022
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
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases