Clinical trial NCT05676463: MRI Guided Radiation Therapy for the Treatment of High Risk Prostate Cancer
Official title: Phase 2 Study of Extreme Hypofractionation Including Pelvic Nodes for High Risk Prostate Cancer Using MgRT (MRI Guided Radiation Therapy)
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE2
Conditions: Prostate Adenocarcinoma
Stage IIIB Prostate Cancer AJCC v8
Stage IIIC Prostate Cancer AJCC v8
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2023-01-09
Enrollment: 88
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of late grade 2+ genitourinary (GU) toxicity
timeFrame: At 1 year
Secondary outcomes:
measure: Incidence of acute GU and gastrointestinal (GI) toxicity
timeFrame: At baseline
measure: Incidence of acute GU and gastrointestinal (GI) toxicity
timeFrame: At treatment completion, up to 10 days
measure: Incidence of acute GU and gastrointestinal (GI) toxicity
timeFrame: every 3 months after treatment until 1 year
measure: Incidence of acute GU and gastrointestinal (GI) toxicity
timeFrame: every 6 months beginning at year 2, assessed up to 4 years
measure: Incidence of late GI toxicity
timeFrame: At baseline
measure: Incidence of late GI toxicity
timeFrame: At treatment completion, up to 10 days
measure: Incidence of late GI toxicity
timeFrame: every 3 months after treatment until 1 year
measure: Incidence of late GI toxicity
timeFrame: every 6 months beginning at year 2, assessed up to 4 years
measure: Overall survival
timeFrame: At baseline
measure: Overall survival
timeFrame: At treatment completion, up to 10 days
measure: Overall survival
timeFrame: every 3 months after treatment until 1 year
measure: Overall survival
timeFrame: every 6 months beginning at year 2, assessed up to 4 years
measure: Prostate cancer specific survival
timeFrame: At baseline
measure: Prostate cancer specific survival
timeFrame: At treatment completion, up to 10 days
measure: Prostate cancer specific survival
timeFrame: every 3 months after treatment until 1 year
measure: Prostate cancer specific survival
timeFrame: every 6 months beginning at year 2, assessed up to 4 years
measure: Biochemical failure
timeFrame: At baseline
measure: Biochemical failure
timeFrame: At treatment completion, up to 10 days
measure: Biochemical failure
timeFrame: every 3 months after treatment until 1 year
measure: Biochemical failure
timeFrame: every 6 months beginning at year 2, assessed up to 4 years
measure: Quality of life measurement
timeFrame: At baseline
measure: Quality of life measurement
timeFrame: At treatment completion, up to 10 days
measure: Quality of life measurement
timeFrame: every 3 months after treatment until 1 year
measure: Quality of life measurement
timeFrame: every 6 months beginning at year 2, assessed up to 4 years
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Sidney Kimmel Cancer Center at Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: Jessie DiNome, MD
role: PRINCIPAL_INVESTIGATOR
References: