MRI Guided Radiation Therapy for the Treatment of High Risk Prostate Cancer

Thomas Jefferson University

Status and phase

Suspended

Phase 2

Conditions

Stage IIIC Prostate Cancer AJCC v8

Prostate Adenocarcinoma

Stage IIIB Prostate Cancer AJCC v8

Treatments

Procedure: Biospecimen Collection

Procedure: MRI-guided Intensity-Modulated Radiation Therapy

Procedure: Computed Tomography

Procedure: Magnetic Resonance Imaging

Procedure: PSMA PET Scan

Other: Quality-of-Life Assessment

Procedure: Bone Scan

Drug: Antiandrogen Therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT05676463

22D.687

Details and patient eligibility

About

This phase II trial tests whether magnetic resonance imaging (MRI)-guided hypofractionated radiation therapy works to reduce treatment time and side effects in patients with high risk prostate cancer. MRI-guided hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time directly to diseased tissue, reducing damage to healthy tissue. Using MRI-guided radiation therapy on areas of the prostate and pelvic lymph nodes may shorten overall treatment time compared to the longer standard of care therapy and may reduce the number and/or duration of side effects.

Full description

PRIMARY OBJECTIVE:

I. Evaluate late grade 2+ genitourinary (GU) toxicity.

SECONDARY OBJECTIVE:

I. Evaluating acute GU and gastrointestinal (GI) toxicity, late GI toxicity, overall survival, prostate cancer specific survival, biochemical failure, and quality of life.

OUTLINE:

Patients undergo MRI-guided intensity-modulated radiation therapy (IMRT) on study and receive standard of care (SOC) antiandrogen therapy (ADT) throughout the trial. Patients may also undergo prostate specific membrane antigen (PSMA) positron emission tomography (PET), computed tomography (CT), MRI, and bone scans at screening and undergo collection of blood samples throughout the trial.

After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for a total of 4 years.

Enrollment

88 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age: above 18 years
Participants must be histologically proven, adenocarcinoma prostate
Localized to the prostate without positive pelvic lymph node involvement
No distant metastatic disease assessed by pretreatment PSMA PET or bone scan and CT scan
High risk prostate cancer as defined by National Comprehensive Cancer Network (NCCN): Gleason score of 8- 10, clinical stage T3a or higher, or prostate specific antigen (PSA) > 20 ng/mL
Ability to receive long term hormone therapy
Karnofsky performance score (KPS) > 70
No prior history of therapeutic irradiation to pelvis
Patient willing and reliable for follow-up and quality of life (QOL)
English speaking/reading

Exclusion criteria

Evidence of distant or pelvic metastasis at any time since presentation
Life expectancy < 2 years
Previous radiation therapy (RT) to prostate or prostatectomy
A previous trans-urethral resection of the prostate (TURP)
Severe urinary symptoms or with severe International Prostate Symptom Score (IPSS) score despite being on hormonal therapy for 6 months which in the opinion of the physician precludes RT
Patients with known obstructive symptoms with stricture
Any contraindication to radiotherapy such as inflammatory bowel disease

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

88 participants in 1 patient group

Treatment (MRI-guided IMRT, ADT)

Experimental group

Description:

Patients undergo MRI-guided IMRT on study and receive SOC ADT throughout the trial. Patients may also undergo PSMA PET, CT, MRI, and bone scans at screening and undergo collection of blood samples throughout the trial.

Treatment: