Lu-PSMA for Oligometastatic Prostate Cancer Treated With STereotactic Ablative Radiotherapy

NCT05560659 | Recruiting Phase 2 DMC

• 1 other identifier: 20/033
• Study Type: interventional
• Target: 92
• Locations: 2 countries
• Sites: 3

Brief Summary

The aim of this study is to assess the progression free survival (PFS) of SABR alone and SABR + 177Lu-prostate-specific membrane antigen (PSMA) in patients with oligometastatic prostate cancer undergoing PSMA positron emission tomography (PET) staging.

Conditions

Oligometastatic Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Evaluate the (bPFS) of SABR alone and SABR + 177Lu-PSMA

  The biochemical progression free survival (bPFS) of SABR alone and SABR + 177Lu-prostate-specific membrane antigen (PSMA) in patients with oligometastatic prostate cancer undergoing PSMA positron emission tomography (PET) staging.

  Through study completion, up until 12 months after the last patient commences treatment

Secondary Outcomes (9)

• The AEs according to CTCAE v5.0

  Through study completion, up until 4 months ± 10 days from the commencement of ADT following progression

• The PSA-response rate

  Through study completion, up until time of biochemical progression +/- 10 days

• The ADT-free survival

  Through study completion, up until biochemical progression +/- 10 days

• The pattern of recurrence on PSMA PET

  Time of biochemical progression +/-10 days

• The patient reported quality of life

  From the date of randomisation to the date of progression

Study Arms (2)

Stereotactic ablative body radiotherapy (SABR) alone

NO INTERVENTION

1-3 fractions of SABR to all sites of disease

SABR plus 2 cycles of 177Lu-PSMA

EXPERIMENTAL

cycles of 177Lu-PSMA with 1-3 fractions of SABR to all sites of disease between cycle 1 and 2

Drug: 177Lu-PSMA

Interventions

177Lu-PSMA DRUG

Lutetium-177 (177Lu)-PSMA is a radiopharmaceutical comprised of a small molecule inhibitor of PSMA that binds with high affinity to PSMA, labelled with 177Lu. 177Lu has favourable characteristics for radionuclide therapy emitting both a short-range (1-2mm) cytotoxic beta-particle, minimising irradiation of non-targeted normal tissues, alongside gamma emission that allows imaging. Numerous retrospective series initially demonstrated high clinical activity and limited normal tissue toxicity using PSMA-617 and PSMA-I\&T, which are the most advanced small molecule inhibitors of PSMA, radiolabelled with 177Lu

SABR plus 2 cycles of 177Lu-PSMA

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Male aged 18 years or older at screening
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male aged 18 years or older at screening
• Patient has provided written informed consent
• Histologically confirmed prostate adenocarcinoma w
• Prior definitive treatment of the primary with either curative intent radiotherapy and/or surgery
• Patient has 1-5 sites of nodal or bony metastases on 68Ga-PSMA or 18F-DCFPyL PET/CT
• Adequate haematological function as defined by:
• Absolute neutrophil count (ANC) ≥1.5 x 109/L
• Platelet count \>150x 109/L
• Haemoglobin ≥100 g/L
• Creatinine Clearance ≥ 40mL/min (Cockcroft-Gault formula)
• Assessed as suitable for SABR by a radiation oncologist
• Patients must agree to use an adequate method of contraception
• Have a performance status of 0-1 on the ECOG Performance Scale

You may not qualify if:

• Prior systemic therapy for metastatic prostate cancer. Prior ADT is allowed but ADT within 6 months of screening for the study is not allowed. If patients have received prior ADT, serum testosterone levels must be above the lower limit of normal
• Any visceral (AJCCC M1c) metastases
• Symptomatic cord compression, or clinical or imaging findings concerning for impending cord compression
• Has a history 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
• Has a known additional malignancy that is progressing or required active treatment in the last 2 years Note: Basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer or carcinoma in situ such as breast cancer in situ that has undergone potentially curative therapy are not excluded.

Sponsors & Collaborators

• Peter MacCallum Cancer Centre, Australia: lead
• Varian Medical Systems: collaborator

Study Sites (3)

Royal North Shore

St Leonards, New South Wales, 2065, Australia

RECRUITING

Peter MacCallum Cancer Centre

Melbourne, Victoria, 3000, Australia

RECRUITING

Sheba Medical Centre

Tel Aviv, Israel

RECRUITING

Study Officials

• A/Prof. Shankar Siva

  Peter MacCallum Cancer Centre, Australia

  PRINCIPAL INVESTIGATOR

• Dr Aravind S. Ravi Kumar

  Peter MacCallum Cancer Centre, Australia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gaurav Sharma

CONTACT

+61 3 8559 6830; Gaurav.Sharma@petermac.org

Annette VanDerHeyden

CONTACT

+61488048792; Annette.VanDerHeyden@petermac.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2022
• First Posted: September 29, 2022
• Study Start: December 14, 2023
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2); IL (1)