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Radioactive Drug

Lutetium PSMA + SBRT for Prostate Cancer (LUNAR Trial)

Phase 2

Waitlist Available

Led By Amar Kishan, MD

Research Sponsored by Jonsson Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to 1 year

Awards & highlights

LUNAR Trial Summary

This trial is testing whether a radioactive drug given before a type of radiation therapy works to improve cancer control rate in patients with 1-5 prostate cancer tumors.

Who is the study for?

Men over 18 with prostate adenocarcinoma that's come back in 1-5 spots after treatment can join. They need good blood counts, liver and kidney function, and must be feeling well enough to do daily activities. No recent hormone therapy for cancer or other solid tumors being treated, no lying flat issues, or allergies to the radioactive drug used.Check my eligibility

What is being tested?

The LUNAR study is testing if a radioactive drug called 177-Lutetium-PSMA given before precise radiation therapy (SBRT) helps control recurrent prostate cancer better. The idea is that the drug targets tumor cells without hurting normal ones and makes SBRT more effective.See study design

What are the potential side effects?

Possible side effects include reactions to the radioactive drug like nausea and fatigue, as well as typical radiation side effects such as skin irritation at the treatment site and tiredness.

LUNAR Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Prostate-specific membrane antigen positron emission tomography/computerized tomography (PSMA PET/CT)-based progression-free survival (PFS)

Secondary outcome measures

Androgen deprivation therapy-free survival (ADT-FS)

Disease progression

Duration of complete response (CR) or partial response (PR)

+9 more

Side effects data

From 2022 Phase 2 trial • 29 Patients • NCT02045446

79%

Cough

64%

Dyspnea

64%

Nausea

57%

Fatigue

43%

Constipation

36%

Pain

36%

Dizziness

29%

Anemia

29%

Back pain

29%

Vomiting

21%

Anorexia

21%

Lymphocyte count decreased

21%

Chest pain

21%

Death NOS

21%

Anxiety

21%

Fall

14%

Wheezing

14%

Dysphagia

14%

Hypotension

14%

Depression

14%

Diarrhea

14%

Platelet count decreased

14%

Abdominal Pain

14%

Edema

14%

Fever

14%

Headache

14%

Insomnia

14%

Palpitations

Alopecia

Creatinine increased

Otitis externa

Sinusitis

Dysgeusia

Hemorrhoids

Amnesia

Confusion

Dementia

Productive cough

Dysuria

Throat pain

Bone marrow biopsy

Hearing impaired

Rash

Hypernatremia

Eye pain

Blurred vision

White blood cell count decreased

Tachycardia

Lung infection

Neuropathy

Hypertension

Neutropenia

Dehydration

Pneumonitis

Pleuritic pain

Hypoxia

Aspiration pneumonia

Blood bilirubin increased

Muscle weakness

Tremor

Weight loss

Thrombocytopenia

Floaters

Toothache

Esophagitis

Leukocytosis

Edema limbs

Gait disturbance

Parathesia (tingling)

Edema face

COPD

100%

80%

60%

40%

20%

Study treatment Arm

Stereotactic Body Radiation Therapy

Maintenance Chemotherapy

LUNAR Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm 2 (177Lu-PNT2002, SBRT)Experimental Treatment3 Interventions

Patients receive 177Lu-PNT2002 IV over 1-10 minutes on days -112 and -56 in the absence of disease progression or unacceptable toxicity. Beginning on day 1, patients then undergo SBRT to all lesions for 1, 3, or 5 treatment doses (fractions) over the span of 10-20 days in the absence of disease progression or unacceptable toxicity.

Group II: Arm 1 (SBRT)Active Control2 Interventions

Beginning on day 1, patients undergo SBRT to all lesions for 1, 3, or 5 treatment doses (fractions) over the span of 10-20 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Stereotactic Body Radiation Therapy

2012

Completed Phase 2

~780

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

POINT Biopharma, a wholly owned subsidiary of Eli Lilly and CompanyIndustry Sponsor

4 Previous Clinical Trials

473 Total Patients Enrolled

1 Trials studying Prostate Cancer

48 Patients Enrolled for Prostate Cancer

Jonsson Comprehensive Cancer CenterLead Sponsor

361 Previous Clinical Trials

27,719 Total Patients Enrolled

39 Trials studying Prostate Cancer

3,982 Patients Enrolled for Prostate Cancer

POINT BiopharmaIndustry Sponsor

5 Previous Clinical Trials

521 Total Patients Enrolled

2 Trials studying Prostate Cancer

96 Patients Enrolled for Prostate Cancer

Media Library

Lutetium Lu-177 PNT2002 (Radioactive Drug) Clinical Trial Eligibility Overview. Trial Name: NCT05496959 — Phase 2

Prostate Cancer Research Study Groups: Arm 1 (SBRT), Arm 2 (177Lu-PNT2002, SBRT)

Prostate Cancer Clinical Trial 2023: Lutetium Lu-177 PNT2002 Highlights & Side Effects. Trial Name: NCT05496959 — Phase 2

Lutetium Lu-177 PNT2002 (Radioactive Drug) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05496959 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA sanctioned Stereotactic Body Radiation Therapy?

"The safety of Stereotactic Body Radiation Therapy was rated a 2 because it is currently in its second clinical trial, offering some indication that the treatment may be safe but no proof yet regarding efficacy."

Answered by AI

How many participants can be enrolled in this experiment?

"Affirmative. The information published on clinicaltrials.gov reflects that this medical experiment is still recruiting participants, having been first posted on September 2nd 2022 and most recently updated on the 7th of same month. This research requires a total of 100 individuals to be enrolled at only one site."

Answered by AI

Are individuals currently signing up to join this experiment?

"Affirmative. According to clinicaltrials.gov, this medical trial is currently recruiting patients and was initially published on September 2nd 2022. 100 individuals must be sourced from a single site before the study's completion date of September 7th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

177-Lutetium-PSMA Before Stereotactic Body Radiotherapy for the Treatment of Oligorecurrent Prostate Cancer, The LUNAR Study

2022. "177-Lutetium-PSMA Before Stereotactic Body Radiotherapy for the Treatment of Oligorecurrent Prostate Cancer, The LUNAR Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05496959.

All > Recurrent Prostate Cancer