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

Sponsor
Telix International Pty Ltd (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05146973
Collaborator
(none)
50
Enrollment
2
Locations
1
Arm
35
Anticipated Duration (Months)
25
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

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
  • Biological: 177Lu-DOTA-TLX591
 Phase 2

Study Design

Study Type:
Interventional
Anticipated 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
Anticipated Study Start Date :
Jul 30, 2022
Anticipated Primary Completion Date :
Jun 30, 2023
Anticipated Study Completion Date :
Jun 30, 2025

Arms and Interventions

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

Primary Outcome Measures

  1. To determine Prostate Specific Antigen Progression Free Survival (PSA PFS) [Through study completion, up to 2 years]

    The time from enrolment to time of PSA increase greater than 25%

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 GenesisCare North Shore St Leonards New South Wales Australia
2 GenesisCare Murdoch Perth Western Australia Australia 6150

Sponsors and Collaborators

  • Telix International Pty Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Telix International Pty Ltd
ClinicalTrials.gov Identifier:
NCT05146973
Other Study ID Numbers:
  • ProstACT TARGET
First Posted:
Dec 7, 2021
Last Update Posted:
Jul 20, 2022
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Prostatic Neoplasms

Study Results

No Results Posted as of Jul 20, 2022