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Prostate CancerPhase 1/2ROADSTERNCT05230251

Radioligand fOr locAl raDiorecurrent proStaTe cancER

A Phase 1/2 study testing 177Lu-PNT2002 and High Dose Radiation in people with Prostate Cancer, run by Glenn Bauman at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
177Lu-PNT2002 and High Dose Radiation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
1 siteCanada
Study dates
17 Mar 2022to 31 Dec 2024
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 13Show fewer
  • -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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • London Health Sciences Centre

    London, Ontario, N6A5W9

Other trials in Canada

About this study

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.

Read the detailed description

Surgery or radiation are common treatments for a prostate cancer that is confined to the prostate gland itself. After radiation treatment, a significant minority of patients (about one third) progress with cancer persistence or cancer regrowth (also known as local recurrence). Patients with local recurrent prostate cancer are eligible for additional treatments directed at the prostate. Prostate Specific Membrane Antigen (PSMA) is protein that is present in high quantities on prostate cancer and radioactive chemical "probes" against PSMA can identify those men with prostate cancer recurrence that is isolated to the prostate.

These radioactive probes can also be used to treat prostate cancer using high energy radioactive materials such as 177-Lutetium (Lu). A standard of care for the treatment of locally recurrent prostate cancer is the use of internal radiation (brachytherapy) delivered through needles inserted into the prostate from the outside. While brachytherapy allows high repeat doses of radiation to be given to the prostate and cancer, there is the potential to injury nearby structures such as the bladder and rectum. 177-Lu PSMA potentially provides a way to give an even more focused treatment to the cancer in the prostate (as well as treat any microscopic cancer that might be outside the prostate). In this study we will test the safety of integrating 177-Lu PSMA into the treatment of locally recurrent prostate cancer in combination with brachytherapy.

A total of 6 men per group (total=12) will be used in the first phase of this project to establish feasibility and safety of the combined treatment. Eligible participants will be chosen randomly to get one cycle of 177-Lu-PSMA treatment followed by brachytherapy treatment or the standard treatment of two brachytherapy treatments without 177-Lu-PSMA. All men will have biopsies (a small piece of tissue) and blood and urine samples taken at the time of the second brachytherapy treatment to compare markers of radiation effect from the first treatment with either 177-Lu-PSMA or brachytherapy. Toxicity assessment and Quality of Life questionnaires will be done at 6 weeks and 6 months after treatment to determine safety. Feasibility will be determined by the proportion of men in whom the treatment is delivered as planned. Provided safety and feasibility are established with the first 12 men, the study will continue to include 15 men per arm (30 men in total).

By developing a new treatment option for men with local recurrence after radiation, ROADSTER will be impactful for this group of men where existing treatments can carry significant side effects and are successful only about half the time.

ROADSTER trial is designed to involve two of the Lawson programs i.e. Imaging and Cancer and the trial participants will be treated in both departments. This inter-disciplinary collaboration is the key to answer the study question.

Conditions
Prostate Cancer
Being tested
177Lu-PNT2002, High Dose Radiation
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 177Lu-PNT2002Drug

    Also called [Lu-177]-PNT2002 Injection

    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.

  • High Dose RadiationRadiation

    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.

Study groups in NCT05230251
Study groupRoleWhat they receive
High Dose Radiation (HDR) armActive comparatorPatients 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).
Receives: Radiation: High Dose Radiation
Lutetium ArmExperimentalPatients in Lutetium Arm will receive 1 cycle of 177Lu-PSMA radioligand therapy plus 1 fraction of HDR brachytherapy.
Receives: Drug: 177Lu-PNT2002; Radiation: High Dose Radiation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: At 24 weeks post treatment

Secondary outcomes (1)

  1. Response rate to treatment

    Response rate to treatment will be measured by serial Prostate Specific Antigen (PSA) with response classified as a >50% decrease compared to pre-treatment PSA levels.

    Measured: Preintervention and T=24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2022
  2. Study start17 Mar 2022
  3. Primary completion25 Sep 2023
  4. Study completion31 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05230251
Sponsor's protocol ID
GB11498
Acronym
ROADSTER
Status last verified
Sep 2025
First submitted
19 Jan 2022
Last updated
12 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 37081426

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing 177Lu-PNT2002 and High Dose Radiation in people with Prostate Cancer, run by Glenn Bauman at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and Efficacy (time frame: At 24 weeks post treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05230251, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.

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