What side effects are associated with this type of intervention?

The most common side effects of targeted radiation delivery treatments like 177-Lutetium-PSMA include myelosuppression (reduced bone marrow activity leading to fewer blood cells), nephrotoxicity (kidney damage), and salivary gland toxicity (pain, swelling, and dry mouth). Other common prostate cancer treatments, such as androgen deprivation therapy (ADT), can cause hot flashes, reduced libido, and bone thinning, while external beam radiation therapy (EBRT) may lead to gastrointestinal issues, urinary problems, and fatigue.

What prior FDA approvals exist?

The FDA has approved several treatments for prostate cancer that involve targeted radiation delivery. One notable example is Radium-223 dichloride (Xofigo), which is used to treat castration-resistant prostate cancer with symptomatic bone metastases and no known visceral metastatic disease. Radium-223 works by mimicking calcium and selectively targeting bone metastases, delivering alpha radiation to kill cancer cells while minimizing damage to surrounding healthy tissue. Another related treatment is Lutetium Lu 177 vipivotide tetraxetan (Pluvicto), which targets prostate-specific membrane antigen (PSMA) and delivers beta radiation directly to prostate cancer cells. These treatments are similar to the 177-Lutetium-PSMA being studied in the LUNAR trial, which aims to improve cancer control in patients with oligorecurrent prostate cancer by combining targeted radiation with stereotactic body radiotherapy (SBRT).

What other types of research exist?

Promising novel alternatives to 177-Lutetium-PSMA for prostate cancer patients include: 1) Radium-223, which targets bone metastases with high-energy alpha particles and has shown improved overall survival in castration-resistant prostate cancer. 2) PSMA-targeted PET imaging agents like Ga-68 PSMA-11 and piflufolastat F-18, which aid in precise detection and treatment planning. 3) Beta-emitting radioisotopes such as strontium-89 and samarium-153, which have been used for pain palliation in bone metastases. 4) Combination therapies involving docetaxel and Ra-223, which have shown durable decreases in tumor markers and improved survival in preliminary studies.

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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

No Placebo-Only Group

Summary

This trial tests if using a radioactive drug, 177-Lutetium-PSMA, before precise radiation therapy can better control prostate cancer that has returned in patients with 1-5 tumors. The drug targets cancer cells directly, and the radiation therapy aims to kill these cells with high precision and fewer side effects. Lutetium-177 (Lu-177) labeled PSMA has shown promising outcomes in treating advanced prostate cancer, including reduced disease progression and improved overall survival.

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.

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Androgen deprivation therapy-free survival (ADT-FS)

Disease progression

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

+8 more

Side effects data

From 2022 Phase 2 trial • 29 Patients • NCT02045446

87%

Fatigue

53%

Nausea

33%

Cough

27%

Anemia

27%

Fall

27%

Dyspnea

27%

Pain

27%

Depression

27%

Lymphocyte count decreased

27%

Platelet count decreased

20%

Chills

20%

Dizziness

20%

Chest pain

20%

Neutropenia

20%

Diarrhea

20%

Edema limbs

13%

Skin infection

13%

Dysesthesia

13%

Insomnia

13%

Edema

13%

Constipation

13%

Delirium

13%

Dysgeusia

13%

Vomiting

13%

Tinnitus

13%

Rash

13%

Myalgia

13%

Back pain

13%

Weakness (limb)

13%

Weight loss

Proteinuria

Bruising

Hearing loss

Anxiety

Oral lesions

Headaches

Weakness (facial)

Acute kidney injury

Hypokalemia

Lymphocytopenia

Seizures

Hearing impaired

Hypernatremia

Hypertension

Neutrophil count decreased

Headache

Creatinine increased

Fever

Pleural effusion

Death NOS

Gait disturbance

Nasal congestion

Tremor

Urinary urgency

Amnesia

Photophobia

Urinary frequency

Dysphagia

Low white blood count

Sneezing

Cognitive disturbance

Erythema multitforme

Lung infection

Allergy (seasonal)

Muscle weakness

Hypomagnesemia

Parathesia (tingling)

Febrile Neutropenia

Anorexia

Hypoxic respiratory failure

Sleep apnea

Encephalopathy

Hypoxia

Shingles

100%

80%

60%

40%

20%

Study treatment Arm

Maintenance Chemotherapy

Stereotactic Body Radiation Therapy

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: 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

~790

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Prostate cancer treatments often include androgen deprivation therapy (ADT), chemotherapy, immunotherapy, and targeted radiation delivery. ADT reduces androgen levels to slow cancer growth, while chemotherapy uses cytotoxic drugs to kill rapidly dividing cells. Immunotherapy stimulates the immune system to attack cancer cells. Targeted radiation delivery, such as 177-Lutetium-PSMA, involves using radioactive substances that specifically bind to prostate-specific membrane antigen (PSMA) on cancer cells, delivering radiation directly to the tumor and minimizing damage to surrounding healthy tissue. This targeted approach is crucial for prostate cancer patients as it enhances treatment efficacy and reduces side effects, improving overall quality of life.

Focal therapy for localized prostate cancer in the era of routine multi-parametric MRI.