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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05146973
• Other study ID #: ProstACT TARGET
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: August 30, 2022
• Est. completion date: August 30, 2024

Study information

• Verified date: April 2024
• Source: Telix Pharmaceuticals (Innovations) Pty Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 radioisotope for the treatment of PSMA-expressing tumours.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 5
• Est. completion date: August 30, 2024
• Est. primary completion date: July 30, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Biological:
• 177Lu-DOTA-TLX591
TLX591, a monoclonal antibody conjugated with a DOTA chelator and radiolabelled with 177Lu (177Lu-DOTA-TLX591)

Locations

Country	Name	City	State
Australia	GenesisCare St Andrews	Adelaide
Australia	GenesisCare Murdoch	Perth	Western Australia
Australia	GenesisCare North Shore	St Leonards	New South Wales
Australia	GenesisCare Tugun	Tugun

Sponsors (1)

Lead Sponsor	Collaborator
Telix Pharmaceuticals (Innovations) Pty Limited

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine Prostate Specific Antigen Progression Free Survival (PSA PFS)	The time from enrolment to time of PSA increase greater than 25%	Through study completion, up to 2 years