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

Prostate Adenocarcinoma Clinical Trial

Official title:

Phase 2 Study of Extreme Hypofractionation Including Pelvic Nodes for High Risk Prostate Cancer Using MgRT (MRI Guided Radiation Therapy)

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT05676463
• Other study ID #: 22D.687
• Status: Suspended
• Phase: Phase 2
• Start date: November 16, 2022
• Est. completion date: December 31, 2027

Study information

• Verified date: November 2023
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 88
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Adenocarcinoma
• Prostatic Neoplasms
• Stage IIIB Prostate Cancer AJCC v8
• Stage IIIC Prostate Cancer AJCC v8

Intervention

Procedure:
• MRI-guided Intensity-Modulated Radiation Therapy
Undergo MRI-guided IMRT

Drug:
• Antiandrogen Therapy
Receive SOC ADT

Procedure:
• PSMA PET Scan
Undergo PSMA PET scan
• Computed Tomography
Undergo CT
• Magnetic Resonance Imaging
Undergo MRI
• Bone Scan
Undergo bone scan
• Biospecimen Collection
Undergo blood sample collection

Other:
• Quality-of-Life Assessment
Ancillary studies

Locations

Country	Name	City	State
United States	Sidney Kimmel Cancer Center at Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of late grade 2+ genitourinary (GU) toxicity	Per Common Terminology Criteria for Adverse Events version 5.0 compared to rate of toxicity in POP-RT trial. Will be estimated for the entire sample that receives the intervention, treating death from any cause (other than treatment) as a competing risk and censoring subjects who drop out before experiencing toxicity at time of last follow-up. A point estimate of cumulative incidence at 1 year will be estimated from this curve along with a two-sided 90% confidence interval. If the upper bound of the interval is less than 20%, the null hypothesis will be rejected.	At 1 year
Secondary	Incidence of acute GU and gastrointestinal (GI) toxicity	Will be estimated using a binomial proportion and exact 95% confidence interval.	At baseline
Secondary	Incidence of acute GU and gastrointestinal (GI) toxicity	Will be estimated using a binomial proportion and exact 95% confidence interval.	At treatment completion, up to 10 days
Secondary	Incidence of acute GU and gastrointestinal (GI) toxicity	Will be estimated using a binomial proportion and exact 95% confidence interval.	every 3 months after treatment until 1 year
Secondary	Incidence of acute GU and gastrointestinal (GI) toxicity	Will be estimated using a binomial proportion and exact 95% confidence interval.	every 6 months beginning at year 2, assessed up to 4 years
Secondary	Incidence of late GI toxicity	Will be estimated using a binomial proportion and exact 95% confidence interval.	At baseline
Secondary	Incidence of late GI toxicity	Will be estimated using a binomial proportion and exact 95% confidence interval.	At treatment completion, up to 10 days
Secondary	Incidence of late GI toxicity	Will be estimated using a binomial proportion and exact 95% confidence interval.	every 3 months after treatment until 1 year
Secondary	Incidence of late GI toxicity	Will be estimated using a binomial proportion and exact 95% confidence interval.	every 6 months beginning at year 2, assessed up to 4 years
Secondary	Overall survival	Will be estimated using the Kaplan-Meier method.	At baseline
Secondary	Overall survival	Will be estimated using the Kaplan-Meier method.	At treatment completion, up to 10 days
Secondary	Overall survival	Will be estimated using the Kaplan-Meier method.	every 3 months after treatment until 1 year
Secondary	Overall survival	Will be estimated using the Kaplan-Meier method.	every 6 months beginning at year 2, assessed up to 4 years
Secondary	Prostate cancer specific survival	Will be estimated using the Kaplan-Meier method.	At baseline
Secondary	Prostate cancer specific survival	Will be estimated using the Kaplan-Meier method.	At treatment completion, up to 10 days
Secondary	Prostate cancer specific survival	Will be estimated using the Kaplan-Meier method.	every 3 months after treatment until 1 year
Secondary	Prostate cancer specific survival	Will be estimated using the Kaplan-Meier method.	every 6 months beginning at year 2, assessed up to 4 years
Secondary	Biochemical failure	Defined as prostate specific antigen nadir plus 2 ng/ml. Will be estimated using the Kaplan-Meier method.	At baseline
Secondary	Biochemical failure	Defined as prostate specific antigen nadir plus 2 ng/ml. Will be estimated using the Kaplan-Meier method.	At treatment completion, up to 10 days
Secondary	Biochemical failure	Defined as prostate specific antigen nadir plus 2 ng/ml. Will be estimated using the Kaplan-Meier method.	every 3 months after treatment until 1 year
Secondary	Biochemical failure	Defined as prostate specific antigen nadir plus 2 ng/ml. Will be estimated using the Kaplan-Meier method.	every 6 months beginning at year 2, assessed up to 4 years
Secondary	Quality of life measurement	Using patient reported outcome-expanded prostate cancer index composite. Will be summarized using descriptive statistics.	At baseline
Secondary	Quality of life measurement	Using patient reported outcome-expanded prostate cancer index composite. Will be summarized using descriptive statistics.	At treatment completion, up to 10 days
Secondary	Quality of life measurement	Using patient reported outcome-expanded prostate cancer index composite. Will be summarized using descriptive statistics.	every 3 months after treatment until 1 year
Secondary	Quality of life measurement	Using patient reported outcome-expanded prostate cancer index composite. Will be summarized using descriptive statistics.	every 6 months beginning at year 2, assessed up to 4 years