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Radioisotope Therapy

Radioligand Therapy for Recurrent Prostate Cancer (ROADSTER Trial)

Phase 2
Waitlist Available
Led By Glenn Bauman, MD
Research Sponsored by Glenn Bauman
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Not currently experiencing genitourinary (GU) or gastrointestinal (GI) Grade 3 or higher toxicity associated with prior treatment
Biopsy confirmation of local recurrence within the prostate
Must not have
Prior ablative radiotherapy to the prostate (prior HDR or LDR brachytherapy or SBRT/SABR to prostate)
Declines HDR salvage or not fit for HDR salvage procedure
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 24 weeks post treatment
Awards & highlights
No Placebo-Only Group

Summary

This trial will test whether adding 177-Lutetium-PSMA to standard salvage brachytherapy improves disease control in men with recurrent prostate cancer.

Who is the study for?
Men with prostate cancer recurrence after prior radiotherapy, confirmed by biopsy. They must have adequate liver and kidney function, no severe toxicity from previous treatments, and meet specific blood count criteria. The trial excludes those who've had certain types of prostate radiotherapy before or show signs of cancer spread beyond the prostate.
What is being tested?
The study is testing a combination treatment for recurrent prostate cancer: high dose radiation (brachytherapy) alongside a radioactive drug called 177Lu-PSMA that targets cancer cells in the prostate and potentially elsewhere in the body.
What are the potential side effects?
Possible side effects include reactions to radiation like skin changes or fatigue, as well as effects from the radioactive drug such as nausea, dry mouth, kidney issues, or blood cell changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I don't have severe urinary or digestive side effects from past treatments.
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My prostate cancer has come back, confirmed by a biopsy.
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My blood counts are within the required range without recent transfusions.
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My kidneys work well enough, based on a specific calculation.
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I can safely undergo high dose rate brachytherapy with general anesthesia.
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My PET scan shows high PSMA activity in the prostate only.
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My liver tests are within the normal range.
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I can safely receive treatment with 177Lu-PSMA.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had targeted radiation therapy to my prostate before.
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I am not suitable for or have declined a specific cancer treatment procedure.
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I am currently using hormone therapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 24 weeks post treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 24 weeks post treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Safety and Efficacy
Secondary study objectives
Response rate to treatment

Side effects data

From 2020 Phase 2 trial • 26 Patients • NCT02805179
77%
Fatigue
42%
Nausea
35%
Constipation
31%
Headache
27%
Platelet count decreased
27%
Dizziness
27%
Insomnia
23%
Alopecia
19%
General disorders and administration site conditions - Other
19%
Pain
15%
Muscle weakness right-sided
15%
Paresthesia
15%
Depression
12%
Eye disorders - Other
12%
Allergic reaction
12%
Dysarthria
12%
Muscle weakness upper limb
12%
Pain in extremity
12%
Anxiety
12%
Pruritus
12%
Seizure
8%
Anemia
8%
Blurred vision
8%
Edema face
8%
Hearing impaired
8%
Diarrhea
8%
Fall
8%
Lymphocyte count decreased
8%
Anorexia
8%
Muscle weakness lower limb
8%
Investigations - Other
8%
Back pain
8%
Generalized muscle weakness
8%
Dysphasia
8%
Confusion
8%
Urinary frequency
8%
Weight gain
8%
Thromboembolic event
8%
Nervous system disorders - Other
8%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other
4%
Flushing
4%
Urinary tract infection
4%
Wound infection
4%
Ventricular tachycardia
4%
Gait disturbance
4%
Muscle weakness left-sided
4%
Salivary duct inflammation
4%
Gastroesophageal reflux disease
4%
Edema limbs
4%
Dyspepsia
4%
Localized edema
4%
Non-cardiac chest pain
4%
Infections and infestations - Other
4%
Papulopustular rash
4%
Sinusitis
4%
Dermatitis radiation
4%
Neck pain
4%
Myalgia
4%
Dysgeusia
4%
Ataxia
4%
Concentration impairment
4%
Hypersomnia
4%
Cough
4%
Renal and urinary disorders - Other
4%
Allergic rhinitis
4%
Apnea
4%
Urticaria
4%
Dyspnea
4%
Nasal congestion
4%
Erythema multiforme
4%
Skin hyperpigmentation
4%
Hypertension
4%
Lymphedema
4%
Ear and labyrinth disorders - Other
4%
Stomach pain
4%
Wound complication
4%
Creatinine increased
4%
Vertigo
4%
Hyponatremia
4%
Tremor
4%
Psychiatric disorders - Other
4%
Cystitis noninfective
4%
Weight loss
4%
Abdominal pain
4%
Dry mouth
4%
Somnolence
100%
80%
60%
40%
20%
0%
Study treatment Arm
All Enrolled Patients

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Lutetium ArmExperimental Treatment2 Interventions
Patients in Lutetium Arm will receive 1 cycle of 177Lu-PSMA radioligand therapy plus 1 fraction of HDR brachytherapy.
Group II: High Dose Radiation (HDR) armActive Control1 Intervention
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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
High Dose Radiation
2016
Completed Phase 2
~30

Find a Location

Who is running the clinical trial?

London Health Sciences FoundationUNKNOWN
2 Previous Clinical Trials
48 Total Patients Enrolled
Glenn BaumanLead Sponsor
1 Previous Clinical Trials
45 Total Patients Enrolled
1 Trials studying Prostate Cancer
45 Patients Enrolled for Prostate Cancer
Glenn Bauman, MDPrincipal InvestigatorLondon Health Sciences Centre
7 Previous Clinical Trials
415 Total Patients Enrolled
4 Trials studying Prostate Cancer
258 Patients Enrolled for Prostate Cancer

Media Library

177Lu-PNT2002 (Radioisotope Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05230251 — Phase 2
Prostate Cancer Research Study Groups: Lutetium Arm, High Dose Radiation (HDR) arm
Prostate Cancer Clinical Trial 2023: 177Lu-PNT2002 Highlights & Side Effects. Trial Name: NCT05230251 — Phase 2
177Lu-PNT2002 (Radioisotope Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05230251 — Phase 2
~3 spots leftby Nov 2025
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