Radioligand fOr locAl raDiorecurrent proStaTe cancER

NCT05230251 | Completed Phase 1 DMC

• 1 other identifier: GB11498
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

Approximately 50-60% of men undergoing salvage brachytherapy post cancer recurrence to the prostate have the disease controlled at 5 years. This study aims to integrate a local treatment to the prostate (brachytherapy) with a treatment involving 177Lutetium (Lu)- Prostate-Specific Membrane Antigen (PSMA) therapy. Differently than brachytherapy, 177-Lutetium-PSMA is thought to have its effect not only to the cancer cells within the prostate, but also to cancer cells located elsewhere in the body. Thus, the idea here is that by adding 177Lutetium (Lu)- PSMA early in the course of treatment we may be able to inactivate potential metastatic cells outside the prostate, while the prostate cancer within this organ still treated by the combination of brachytherapy and 177-Lutetium-PSMA.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Safety and Efficacy

  As a proof of concept study the primary endpoint will be feasibility and safety. Feasibility will be defined as the ability to complete all study interventions up to and including the 6 month assessment. Safety will be defined as no Grade \>3 toxicity up to and including the 6 months assessment.

  At 24 weeks post treatment

Secondary Outcomes (1)

• Response rate to treatment

  Preintervention and T=24 weeks

Study Arms (2)

High Dose Radiation (HDR) arm

ACTIVE COMPARATOR

Patients in the HDR arm will receive two fractions of HDR brachytherapy. HDR brachytherapy will be administered as per local practice and as previously described. All procedures will be conducted under general anesthesia in a dedicated brachytherapy suite using transrectal three dimensional ultrasound for image guidance. For all HDR fractions at least 10Gy will be delivered to the entire prostate with a boost to 13.5Gy to the involved prostate as determined by biopsy and PSMA PET/MRI results. In instances of multi-focal/diffuse involvement of the prostate, the entire prostate will receive 13.5Gy/fraction (respecting OAR constraints).

Radiation: High Dose Radiation

Lutetium Arm

EXPERIMENTAL

Patients in Lutetium Arm will receive 1 cycle of 177Lu-PSMA radioligand therapy plus 1 fraction of HDR brachytherapy.

Drug: 177Lu-PNT2002; Radiation: High Dose Radiation

Interventions

177Lu-PNT2002 DRUG

Men randomized to receive 177Lu-PSMA will receive 1 cycle of 177Lu-PSMA at a dose of 6.8MBq administered intravenously 2 weeks prior to the planned HDR administration in the Department of Nuclear Medicine as per local practice for the administration of therapeutic radiopharmaceuticals and consistent with good practices.

Also known as: [Lu-177]-PNT2002 Injection

Lutetium Arm

High Dose Radiation RADIATION

HDR brachytherapy will be administered as per local practice. All procedures will be conducted under general anesthesia in a dedicated brachytherapy suite using transrectal three dimensional ultrasound for image guidance. For all HDR fractions at least 10Gy will be delivered to the entire prostate with a boost to 13.5Gy to the involved prostate as determined by biopsy and PSMA PET/MRI results. In instances of multi-focal/diffuse involvement of the prostate, the entire prostate will receive 13.5Gy/fraction.

High Dose Radiation (HDR) arm; Lutetium Arm

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: As prostate cancer is a disease of male sex, the research project is inherently targeted to this population of patients.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men with prostate adenocarcinoma treated with prior primary radiotherapy at least 2 years previously
• Biochemical failure according to the Phoenix criteria(Roach et al. 2006)
• PSMA PET demonstrating isolated uptake (SUV\>3) within the prostate
• Biopsy confirmation of local recurrence within the prostate
• Not currently experiencing genitourinary (GU) or gastrointestinal (GI) Grade 3 or higher toxicity associated with prior treatment
• Adequate marrow function (Absolute neutrophil count ≥ 1.5 x 109/L -Platelet count ≥ 100 x 109/L
• Hemoglobin ≥ 90 g/L with no transfusions in the past 2 weeks)
• Adequate renal function: Estimated creatinine clearance ≥ 30 ml/min according to Cockroft Gault equation:
• (140 - age) x (weight in kg) / 72 x (serum creatinine)
• Adequate liver function: Total bilirubin \< 1.5 x upper limit of normal (ULN). Alanine aminotransferase (ALT) \< 3.5 x ULN
• No contraindication to treatment with \[177Lu-PSMA Agent\]
• No contraindication to MRI
• No contraindication to therapy with high dose rate brachytherapy under general anaesthetic

You may not qualify if:

• Does not meet eligibility criteria
• Prior ablative radiotherapy to the prostate (prior HDR or LDR brachytherapy or SBRT/SABR to prostate)
• Documented extraprostatic or distant recurrence on PSMA PET
• Consent not obtained or declines randomization
• Declines HDR salvage or not fit for HDR salvage procedure
• Concurrent use of hormone therapy

Sponsors & Collaborators

• Glenn Bauman: lead
• London Health Sciences Foundation: collaborator

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A5W9, Canada

Location

Related Publications (1)

• Mendez LC, Dhar A, Laidley D, Moussa M, Gomez JA, Chin J, Lee TY, Thiessen JD, Hoover D, Surrey K, Helou J, Velker V, Correa RJ, D'Souza D, Bayani J, Bauman G. The use of Lutetium-177 PSMA radioligand therapy with high dose rate brachytherapy for locally recurrent prostate cancer after previous definitive radiation therapy: a randomized, single-institution, phase I/II study (ROADSTER). BMC Cancer. 2023 Apr 20;23(1):362. doi: 10.1186/s12885-023-10851-0.

  PMID: 37081426 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiation

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Physical Phenomena

Study Officials

• Glenn Bauman, MD

  London Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Radiation Oncologist

Study Record Dates

• First Submitted: January 19, 2022
• First Posted: February 8, 2022
• Study Start: March 17, 2022
• Primary Completion: September 25, 2023
• Study Completion: December 31, 2024
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)