Clinical trial NCT05568537: Prostate MRI and Pylarify PSMA PET/CT
Official title: Monitoring Prostate Cancer Tumor Response to Radiation Therapy Using Advanced Functional Magnetic Resonance Imaging (MRI) and Pylarify (18F-DCFPyL) PSMA Positron Emission Tomography (PET)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Prostate Cancer
Keywords: MRI
PSMA PET
Pylarify
androgen deprivation therapy
radiation therapy
Pylarify Piflufolastat Flourine-18 (18F-DCFPyL)
Lead sponsor: William Beaumont Hospitals
Sponsor class: OTHER
First posted: 2022-10-05
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Non-randomized, prospective, single-institution
Primary purpose: TREATMENT

Brief summary: This is a voluntary research study to find out how using technology including advanced magnetic resonance imaging (MRI) and prostate-specific membrane antigen - positron emission tomography (PSMA-PET) scan imaging, in addition to combined prostate treatment using radiation therapy, brachytherapy (internal radiation treatment using small radioactive seeds placed inside the body) and androgen deprivation therapy (drug therapy to suppress hormones) can help doctors see, track and predict tumor response to treatment for prostate cancer patients. Participation in this study will consist of radiation planning and simulation, magnetic resonance imaging (MRI) and positron emission tomography and computed tomography scan (PET/CT). One MRI and PSMA PET/CT scan will be done prior to the start of first external beam radiation therapy (EBRT) fraction. At mid-treatment prior to the second brachytherapy fraction, an MRI and PSMA PET/CT will be done. A third scan will be performed after 75% testosterone recovery or 12 months post androgen deprivation therapy (ADT) \[whichever comes first\].

Detailed description: The goal of the study is to better understand how an individual tumor responds to radiation therapy and determine if advanced imaging can be used for prognostic purposes, especially to predict areas of local resistance and failure. The study population are patients with high risk prostate malignancy treated with a combination of external beam radiation therapy (EBRT)/brachytherapy (BT) and androgen deprivation therapy (ADT). Patients enrolled in this trial will undergo a pre-treatment MRI and PSMA PET/CT prior to the initiation of ADT and the first EBRT fraction, a mid-treatment MRI and PSMA PET/CT prior to second brachytherapy fraction, and a third MRI and PSMA PET/CT will be performed after 75% testosterone recovery or 12 months post-ADT (whichever comes first). The pre-treatment MRI and PSMA PET/CT is part of standard of care for prostate cancer workup, however all additional MRI and PSMA PET/CT mid-treatment or after treatment completion are additional research scans.

Eligibility criteria: Inclusion Criteria

* Planned definitive radiation for high-risk prostate cancer, radiotherapy plan to include high dose-rate (HDR) brachytherapy boost
* High-risk prostate cancer (tumor stage cT3a-cT4, OR Grade Group 4 or 5, OR prostate-specific antigen (PSA) \>20 ng/mL)
* Patients with clinically positive regional lymph nodes
* Patient planned to receive at least 12 months of androgen deprivation therapy
* Age ≥18 years
* No maximum age cutoff, however must have life expectancy \> 5 years based on patient's overall health
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Patient able to have 3-Tesla (3T) MRI per Beaumont Radiation Oncology MRI safety questionnaire

Exclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance status 3-5
* Metastatic disease
* Prior androgen deprivation therapy before study enrollment
* Prior radiation to pelvis
* Prior malignancy not achieving remission or with prognosis \< 5 years
* Synchronous malignancy confirmed or suspected
* Any patient not suitable for brachytherapy
* Severe claustrophobia precluding the acquisition of MRI
* Unable to safely have 3T MRI
* Cognitively impaired

Primary outcomes:
measure: Difference from baseline (pre-treatment) to mid-treatment scans for each patient in molecular/metabolic MRI to second brachytherapy treatment
timeFrame: From start of treatment to before brachytherapy dose number 2, approximately day 15 of treatment
measure: Difference from baseline (pre-treatment) to end of treatment scans for each patient in molecular/metabolic MRI to second brachytherapy treatment
timeFrame: From start of treatment to 1 year after completion of treatment or recovery of 75% baseline testosterone after androgen depletion therapy.
measure: Difference from baseline (pre-treatment) to mid-treatment scans for each patient in PSMA PET/CT
timeFrame: From start of treatment to before brachytherapy dose number 2, approximately day 15 of treatment
measure: Difference from baseline (pre-treatment) to end-of-treatment scans for each patient in PSMA PET/CT
timeFrame: From start of treatment to 1 year after completion of treatment or recovery of 75% baseline testosterone after androgen depletion therapy.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: William Beaumont Hospitals
name: Sirisha Nandular, MD
role: PRINCIPAL_INVESTIGATOR
References: