Using Lu-PSMA with SABR for treating oligometastatic prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the effectiveness of combining stereotactic ablative radiotherapy (SABR) with Lutetium-177 prostate-specific membrane antigen (Lu-PSMA) therapy in improving progression-free survival in patients with oligometastatic prostate cancer. Participants will undergo PSMA PET staging to identify suitable candidates with 1-5 metastatic sites. The study will compare outcomes between those receiving SABR alone and those receiving the combination treatment. The goal is to determine if the addition of Lu-PSMA enhances treatment efficacy over standard SABR alone.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Male aged 18 years or older at screening
2. Patient has provided written informed consent
3. Histologically confirmed prostate adenocarcinoma w
4. Prior definitive treatment of the primary with either curative intent radiotherapy and/or surgery
5. Patient has 1-5 sites of nodal or bony metastases on 68Ga-PSMA or 18F-DCFPyL PET/CT
6. 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)
7. Assessed as suitable for SABR by a radiation oncologist
8. Patients must agree to use an adequate method of contraception
9. Have a performance status of 0-1 on the ECOG Performance Scale

Exclusion Criteria:

1. 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
2. Any visceral (AJCCC M1c) metastases
3. Symptomatic cord compression, or clinical or imaging findings concerning for impending cord compression
4. 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
5. 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.

Where it's running

• Royal North Shore
  St Leonards, New South Wales, Australia Recruiting
• Peter MacCallum Cancer Centre
  Melbourne, Victoria, Australia Recruiting
• Icon Cancer Centre
  Melbourne, Victoria, Australia Recruiting
• Sheba Medical Centre
  Tel Aviv, Israel Recruiting

Study contacts

• Principal investigator: A/Prof. Shankar Siva — Peter MacCallum Cancer Centre, Australia
• Study coordinator: Haris Ahmad
• Email: haris.ahmad@petermac.org
• Phone: +61 3 8559 8566

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Prostate Radiotherapy and Metastasis-Directed Therapy in Synchronous Oligometastatic Prostate Cancer

  This registry follows men with new, limited metastatic prostate cancer who receive targeted radiotherapy to the prostate and all visible metastases to see how they do over time in real-world care.

  Recruiting Affidea Nu-med Center of Oncological DIagnostics and Therapy · Zamość, Lublin Voivodeship · NCT07686016

• Comprehensive radiotherapy to all metastases plus primary prostate radiotherapy versus prostate-only radiotherapy for men with oligometastatic prostate cancer

  This tests whether adding radiation to all PSMA-PET-visible metastases along with standard systemic therapy helps men with newly diagnosed oligometastatic prostate cancer stay progression-free longer than treating the prostate alone.

  Recruiting Peking University First Hospital · Beijing, Beijing Municipality and 2 other locations · NCT07015138

• Maximal tumor eradication for patients with oligometastatic prostate cancer

  This study is testing a new combination treatment for men with oligometastatic prostate cancer to see if it can improve their survival and quality of life.

  Recruiting Phase 2/3 RenJi Hospital · Shanghai · NCT06972511

• Genomic biomarker-guided therapy for advanced prostate cancer

  This study is testing if personalized treatment based on genetic markers can help men with advanced prostate cancer before surgery.

  Recruiting Phase 2 The First Affiliated Hospital of Xiamen University · Xiamen, Fujian · NCT06387056

• Combining immune therapy and radiation for prostate cancer treatment

  This study is testing a new treatment that combines immune therapy drugs with targeted radiation to see if it helps men with a specific type of prostate cancer live longer and feel better.

  Recruiting Phase 2 Columbia University · New York, New York · NCT05915442

• Comparing different radiation therapies for treating oligometastatic prostate cancer

  This study is testing whether new types of radiation therapy can help men with oligometastatic prostate cancer feel better and live longer compared to standard treatment.

  Recruiting at 3 sites British Columbia Cancer Agency · Kelowna, British Columbia and 3 other locations · NCT04610372

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.