Trial Title:
FDG-PET-Guided Metastasis Directed Radiation Therapy for the Treatment of Metastatic Hormone Sensitive Prostate Cancer, The PRTY Trial
NCT ID:
NCT06244004
Condition:
Castration-Sensitive Prostate Carcinoma
Metastatic Prostate Carcinoma
Stage IVB Prostate Cancer AJCC v8
Conditions: Official terms:
Carcinoma
Prostatic Neoplasms
Hypersensitivity
Ascorbic Acid
Methyltestosterone
Hormones
Estrogens, Conjugated (USP)
Androgens
Androgen Antagonists
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Antiandrogen Therapy
Description:
Undergo SOC ADT
Arm group label:
Arm 1A (FDG-PET, MDRT, SOC cytotoxic chemotherapy & ADT)
Arm group label:
Arm 1B (FDG-PET, SOC cytotoxic chemotherapy & ADT)
Arm group label:
Arm 1C (FDG-PET, SOC cytotoxic chemotherapy & ADT)
Arm group label:
Arm 2A (FDG-PET, MDRT, SOC ADT)
Arm group label:
Arm 2B (FDG-PET, SOC ADT)
Arm group label:
Arm 2C (FDG-PET, SOC ADT)
Other name:
ADT
Other name:
Androgen Deprivation Therapy
Other name:
Androgen Deprivation Therapy (ADT)
Other name:
Anti-androgen Therapy
Other name:
Anti-androgen Treatment
Other name:
Antiandrogen Treatment
Other name:
Hormone Deprivation Therapy
Other name:
Hormone-Deprivation Therapy
Intervention type:
Procedure
Intervention name:
Bone Scan
Description:
Undergo bone scan
Arm group label:
Arm 1A (FDG-PET, MDRT, SOC cytotoxic chemotherapy & ADT)
Arm group label:
Arm 1B (FDG-PET, SOC cytotoxic chemotherapy & ADT)
Arm group label:
Arm 1C (FDG-PET, SOC cytotoxic chemotherapy & ADT)
Arm group label:
Arm 2A (FDG-PET, MDRT, SOC ADT)
Arm group label:
Arm 2B (FDG-PET, SOC ADT)
Arm group label:
Arm 2C (FDG-PET, SOC ADT)
Other name:
Bone Scintigraphy
Intervention type:
Procedure
Intervention name:
Computed Tomography
Description:
Undergo CT
Arm group label:
Arm 1A (FDG-PET, MDRT, SOC cytotoxic chemotherapy & ADT)
Arm group label:
Arm 1B (FDG-PET, SOC cytotoxic chemotherapy & ADT)
Arm group label:
Arm 1C (FDG-PET, SOC cytotoxic chemotherapy & ADT)
Arm group label:
Arm 2A (FDG-PET, MDRT, SOC ADT)
Arm group label:
Arm 2B (FDG-PET, SOC ADT)
Arm group label:
Arm 2C (FDG-PET, SOC ADT)
Other name:
CAT
Other name:
CAT Scan
Other name:
Computed Axial Tomography
Other name:
Computerized Axial Tomography
Other name:
Computerized axial tomography (procedure)
Other name:
Computerized Tomography
Other name:
CT
Other name:
CT Scan
Other name:
tomography
Intervention type:
Drug
Intervention name:
Cytotoxic Chemotherapy
Description:
Receive SOC cytotoxic chemotherapy
Arm group label:
Arm 1A (FDG-PET, MDRT, SOC cytotoxic chemotherapy & ADT)
Arm group label:
Arm 1B (FDG-PET, SOC cytotoxic chemotherapy & ADT)
Arm group label:
Arm 1C (FDG-PET, SOC cytotoxic chemotherapy & ADT)
Other name:
Cytotoxic
Other name:
Cytotoxic Therapy
Intervention type:
Procedure
Intervention name:
FDG-Positron Emission Tomography
Description:
Undergo FDG-PET
Arm group label:
Arm 1A (FDG-PET, MDRT, SOC cytotoxic chemotherapy & ADT)
Arm group label:
Arm 1B (FDG-PET, SOC cytotoxic chemotherapy & ADT)
Arm group label:
Arm 1C (FDG-PET, SOC cytotoxic chemotherapy & ADT)
Arm group label:
Arm 2A (FDG-PET, MDRT, SOC ADT)
Arm group label:
Arm 2B (FDG-PET, SOC ADT)
Arm group label:
Arm 2C (FDG-PET, SOC ADT)
Other name:
FDG
Other name:
FDG-PET
Other name:
FDG-PET Imaging
Intervention type:
Radiation
Intervention name:
Radiation Therapy
Description:
Undergo MDRT
Arm group label:
Arm 1A (FDG-PET, MDRT, SOC cytotoxic chemotherapy & ADT)
Arm group label:
Arm 2A (FDG-PET, MDRT, SOC ADT)
Other name:
Cancer Radiotherapy
Other name:
Energy Type
Other name:
ENERGY_TYPE
Other name:
Irradiate
Other name:
Irradiated
Other name:
Irradiation
Other name:
Radiation
Other name:
Radiation Therapy, NOS
Other name:
Radiotherapeutics
Other name:
Radiotherapy
Other name:
RT
Other name:
Therapy, Radiation
Summary:
This phase II trial compares the effect of FDG-positron emission tomography (PET)-guided
metastasis directed radiation therapy (MDRT) in combination with standard treatments to
standard treatments alone in treating patients with prostate cancer that is sensitive to
androgen-deprivation therapy (ADT) and has spread from where it first started (primary
site) to other places in the body (metastatic). Prostate cancer is the second leading
cause of cancer death among men in the United States, despite the approval of several
life-prolonging treatments by the Food and Drug Administration. However, over the past 10
years, there have been significant improvements in prolonging the lives of those with
metastatic hormone sensitive prostate cancer, specifically by adding treatments to
standard therapy, such as ADT. More recently, trials have demonstrated a benefit of using
radiotherapy (high energy x-rays, particles, or radioactive seeds to kill cancer cells
and shrink tumors) to delay the progression of cancer and prolong life for patients with
metastatic disease. Imaging scans with FDG-PET may be able to identify cancer sites that
remain active despite standard treatment. Giving MDRT plus standard treatment to patients
with FDG-PET-identified cancer sites may work better than standard treatment alone in
treating metastatic hormone sensitive prostate cancer.
Detailed description:
PRIMARY OBJECTIVES:
I. To compare the progression free survival (PFS) between standard of care (SOC) + MDRT
(Arm 1A) versus (vs) SOC alone (Arm 1B). (Cohort 1 [cytotoxic therapy cohort]) II. To
compare the proportions of patients in Arm 2A vs Arm 2B who attain complete response (CR)
6 months after randomization. (Cohort 2 [non-cytotoxic therapy cohort])
SECONDARY OBJECTIVES:
I. To compare the radiographic progression-free survival (rPFS) between Arms 1A and 1B.
(Cohort 1 [cytotoxic therapy cohort]) II. To determine the proportions of patients with
metastatic hormone sensitive prostate cancer (mHSPC) who achieve a serum
prostate-specific antigen (PSA) level < 4 ng/mL and < 0.01 ng/mL and compare them between
Arm 1A and 1B. (Cohort 1 [cytotoxic therapy cohort]) III. To determine the proportion of
patients with skeletal related events (SRE), and compare them between Arms 1A and 1B.
(Cohort 1 [cytotoxic therapy cohort]) IV. To assess the safety and toxicity of MDRT
during and following MDRT completion. (Cohort 1 [cytotoxic therapy cohort]) V. To
determine the objective response rate (ORR), defined as the proportion of patients who
experience a confirmed complete response (CR) or confirmed partial response (PR) on
fludeoxyglucose F-18 (FDG)-PET-2, and to compare ORR between Arms 2A and 2B. (Cohort 2
[non-cytotoxic therapy cohort]) VI. To determine the progression-free survival (PFS) and
radiographic progression-free survival (rPFS), and to compare between Arms 2A and 2B.
(Cohort 2 [non-cytotoxic therapy cohort]) VII. To determine the proportions of patients
with mHSPC who achieve a serum PSA level < 4 ng/mL and < 0.01 ng/mL (undetectable), and
compare them between Arms 2A and 2B. (Cohort 2 [non-cytotoxic therapy cohort]) VIII. To
determine the proportion of patients with skeletal related events (SRE), and compare them
between Arms 2A and 2B. (Cohort 2 [non-cytotoxic therapy cohort]) IX. To assess the
safety and toxicity of MDRT during and following MDRT completion. (Cohort 2
[non-cytotoxic therapy cohort])
EXPLORATORY OBJECTIVES:
I. To examine association between imaging features and progression free survival (Cohort
1) or likelihood of response (Cohort 2).
II. To determine the time to treatment discontinuation (TTD) in Cohort 1 Arm 1A, 1B, and
1C, and Cohort 2 Arms 2A, 2B and 2C.
OUTLINE: Patients undergoing cytotoxic chemotherapy are assigned to Cohort 1, while
patients not undergoing cytotoxic chemotherapy are assigned to Cohort 2.
COHORT 1: Patients undergo an FDG-PET scan after 6 months of SOC cytotoxic chemotherapy +
androgen deprivation therapy (ADT). Patients with PET-avid disease are randomized to Arm
1A or 1B. Patients without PET-avid disease are assigned to Arm 1C.
ARM 1A: Patients continue their SOC ADT and undergo MDRT to up to 5 disease sites in the
absence of unacceptable toxicity. Patients also undergo computed tomography (CT) and bone
scans throughout the trial.
ARM 1B: Patients continue their SOC ADT on study. Patients also undergo CT and bone scans
throughout the trial.
ARM 1C: Patients continue their SOC ADT on study. Patients also undergo CT and bone scans
throughout the trial.
COHORT 2: Patients undergo an FDG-PET scan after 6 months of SOC ADT. Patients with
PET-avid disease are randomized to Arm 2A or 2B. Patients without PET-avid disease are
assigned to Arm 2C.
ARM 2A: Patients continue their SOC ADT and undergo MDRT to up to 5 disease sites in the
absence of unacceptable toxicity. Patients undergo an additional FDG-PET scan at 6
months. Patients also undergo CT and bone scans throughout the trial.
ARM 2B: Patients continue their SOC ADT on study and undergo an additional FDG-PET scan
at 6 months. Patients also undergo CT and bone scans throughout the trial.
ARM 2C: Patients continue their SOC ADT on study and undergo an additional FDG-PET scan
at 6 months. Patients also undergo CT and bone scans throughout the trial.
After completion of study treatment, patients are followed up at 3 months (Arms 1A, 1B,
2A, 2B only) and 6 months, and then every 6 months until 36 months.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients must have metastatic prostate cancer on conventional imaging (CT scan, MRI,
and/or bone scan).
- Note; Patients who had metastatic disease on conventional imaging prior to
beginning ADT, but which has now resolved, are still eligible if they meet
remaining eligibility criteria
- Patients must be ≥ 18 years of age at the time of informed consent.
- Patients must exhibit an Eastern Cooperative Oncology Group (ECOG) performance
status of 0-3.
- Planned treatment requirements:
- Cohort 1
- Patients must have mHSPC and be planning therapy with cytotoxic therapy,
with or without an androgen receptor (AR) pathway inhibitor (ARPI), to be
eligible for Cohort 1. Patients may also enroll if they are currently
receiving or have completed cytotoxic therapy, if they are within 26 weeks
+/- 4 weeks (30 weeks) of starting cytotoxic therapy and 26 weeks +/- 26
weeks (one year) of starting ADT.
- Note:
- Typically cytotoxic therapy means docetaxel. Patients planning
other cytotoxic therapy (e.g. cabazitaxel) should discuss this
with the study principal investigator (PI).
- If a patient registers as part of cohort 1 but ends up not
receiving any cytotoxic therapy, the patient may be switched to
cohort 2. This must be discussed with the study PI. If the
patient received at least one cycle of cytotoxic therapy, they
would remain in cohort 1.
- Patients will continue their standard of care treatment while on
study (plus MDRT if they are on Arm 1A). Change in standard of
care therapy will be allowed for toxicity or for de-escalation,
and the patient will remain on study. Change in therapy for
progression is considered a progression event.
- Cohort 2
- Patients must have mHSPC and be planning therapy with androgen deprivation
therapy (ADT), with or without an ARPI, and not planning cytotoxic
therapy, to be eligible for Cohort 2. Patients may also enroll if they are
within 26 weeks +/- 4 weeks (30 weeks) of starting an AR pathway inhibitor
and 26 weeks +/- 26 weeks (one year) of starting ADT.
- Note:
- If patients register as part of cohort 2 but end up receiving
one or more cycles of cytotoxic therapy, they may be switched to
cohort 1. This must be discussed with the study PI.
- Patients will continue their standard of care treatment while on
study (plus MDRT if they are on Arm 2A). If they switch therapy
because of progression, they will be considered to have
progressed.
- Patients can be enrolled anytime within the initial ~6 month
standard of care time period, though early enrollment is
preferred. Screening can take place prior to starting standard
of care (SOC) therapy or during standard of care therapy, as
long as they are within 30 weeks of starting therapy.
- Leukocytes (WBC) ≥ 2,500/mcL (growth factor use allowed) (obtained prior to
registration).
- Absolute neutrophil count (ANC) ≥ 1,500/mcL (growth factor use allowed) (obtained
prior to registration).
- Platelets (PLT) ≥ 80,000/mcL (transfusions allowed) (obtained prior to
registration).
- Patient must be able to lie flat and still for approximately 15-20 minutes AND able
to tolerate FDG-PET/CT radiographical imaging and radiation treatment planning and
delivery.
- Patients with a prior or concurrent malignancy whose natural history or treatment
does not have the potential to interfere with the endpoints for this study, in the
opinion of the treating investigator, are eligible.
- Note; Patients are ineligible if another known malignancy makes it difficult to
interpret if FDG-avid lesions represent prostate cancer, or if the malignancy
is expected to interfere with patients receiving standard therapy for prostate
cancer for 2 years from study enrollment.
- Patients must have a life expectancy of at least 6 months, in the opinion of the
treating investigator.
- Patients must have the ability to understand and the willingness to sign a written
informed consent document prior to registration.
- Note: Patients with impaired decision-making capacity (IDMC) who have a legally
authorized representative (LAR) or caregiver and/or family member available
will also be considered eligible.
Exclusion Criteria:
- Patients with prostate cancer that is castration resistant, which is defined as two
consecutive rising PSA values despite testosterone level < 50 ng/dL.
- Patients who started androgen deprivation therapy (ADT) more than 26 weeks +/- 26
weeks (1 year) prior to enrollment.
- Note: ADT is defined as luteinizing hormone-releasing hormone (LHRH) agonist
(e.g. leuprolide, goserelin) or antagonist (e.g. degarelix, relugolix) or
surgical castration. Bicalutamide 50 mg daily does not count as ADT.
- Note: Patients will not be excluded if they were previously on intermittent
therapy, as long as the current "on" period started within one year of
enrollment.
- Patients who started intensification of therapy beyond ADT (e.g., AR pathway
inhibitor, cytotoxic therapy) more than 26 weeks +/- 4 weeks (30 weeks) prior to
registration.
- Note: First generation antiandrogens (bicalutamide) are not considered
intensification of therapy beyond ADT.
- Subjects with a known allergy to contrast material and/or contraindication to
FDG-PET
- Note: Contrast allergies: Patients with a known allergy to imaging contrast
agent(s) are eligible, provided prior reactions have not been severe, and the
patient is willing and able to receive pre-medications and/or supportive care
according to institutional standard practice (e.g., corticosteroids,
antihistamines, etc.) to manage reactions adequately.
- Patients who are enrolled in another therapeutic clinical trial that would preclude
them from participating in this trial.
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Northwestern University
Address:
City:
Chicago
Zip:
60611
Country:
United States
Status:
Recruiting
Contact:
Last name:
David VanderWeele
Phone:
312-926-2413
Email:
david.vanderweele@northwestern.edu
Investigator:
Last name:
David VanderWeele
Email:
Principal Investigator
Facility:
Name:
Northwestern Medicine: Kishwaukee
Address:
City:
DeKalb
Zip:
60115
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
312-695-1301
Email:
cancer@northwestern.edu
Investigator:
Last name:
David VanderWeele, MD, PHD
Email:
Principal Investigator
Facility:
Name:
Northwestern Medicine: Delnor
Address:
City:
Geneva
Zip:
60134
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
312-695-1301
Email:
cancer@northwestern.edu
Investigator:
Last name:
David VanderWeele, M
Email:
Principal Investigator
Facility:
Name:
Northwestern Medicine Orland Park
Address:
City:
Orland Park
Zip:
60462
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Study Coordinator
Phone:
312-695-1301
Email:
cancer@northwestern.edu
Investigator:
Last name:
David VanderWeele, MD, PhD
Email:
Principal Investigator
Facility:
Name:
Northwestern Medicine: Warrenville
Address:
City:
Warrenville
Zip:
60555
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
312-695-1301
Email:
cancer@northwestern.edu
Investigator:
Last name:
David VanderWeele, MD, PhD
Email:
Principal Investigator
Start date:
February 18, 2024
Completion date:
February 18, 2028
Lead sponsor:
Agency:
Northwestern University
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
Northwestern University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06244004
