Recruiting
Phase 2

FDG-PET-Guided Therapy

Sponsor:

Northwestern University

Code:

NCT06244004

Conditions

Castration-Sensitive Prostate Carcinoma

Metastatic Prostate Carcinoma

Stage IVB Prostate Cancer AJCC v8

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Antiandrogen Therapy

Bone Scan

Computed Tomography

Cytotoxic Chemotherapy

FDG-Positron Emission Tomography

Study Details

Brief 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.

Conditions

Castration-Sensitive Prostate Carcinoma

Metastatic Prostate Carcinoma

Stage IVB Prostate Cancer AJCC v8

Study ID

NCT06244004

Start date

Feb 18, 2024

Status verified date

Mar, 2026

Completion date

Feb 18, 2028

Anticipated

Primary completion date

Feb 18, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

125 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm 1A (FDG-PET, MDRT, SOC cytotoxic chemotherapy & ADT)

Patients undergo an FDG-PET scan after 6 months of SOC cytotoxic chemotherapy + ADT. Patients with PET-avid disease continue their SOC ADT and undergo MDRT to up to 5 disease sites in the absence of unacceptable toxicity. Patients also undergo CT and bone scans throughout the trial.

active comparator: Arm 1B (FDG-PET, SOC cytotoxic chemotherapy & ADT)

Patients undergo an FDG-PET scan after 6 months of SOC cytotoxic chemotherapy + ADT. Patients with PET-avid disease continue their SOC ADT on study. Patients also undergo CT and bone scans throughout the trial.

active comparator: Arm 1C (FDG-PET, SOC cytotoxic chemotherapy & ADT)

Patients undergo an FDG-PET scan after 6 months of SOC cytotoxic chemotherapy + ADT. Patients without PET-avid disease continue their SOC ADT on study. Patients also undergo CT and bone scans throughout the trial.

experimental: Arm 2A (FDG-PET, MDRT, SOC ADT)

Patients undergo an FDG-PET scan after 6 months of SOC ADT. Patients with PET-avid disease 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.

active comparator: Arm 2B (FDG-PET, SOC ADT)

Patients undergo an FDG-PET scan after 6 months of SOC ADT. Patients with PET-avid disease 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.

active comparator: Arm 2C (FDG-PET, SOC ADT)

Patients undergo an FDG-PET scan after 6 months of SOC ADT. Patients without PET-avid disease 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.

Interventions

Antiandrogen Therapy

Undergo SOC ADT

Bone Scan

Undergo bone scan

Computed Tomography

Undergo CT

Cytotoxic Chemotherapy

Receive SOC cytotoxic chemotherapy

FDG-Positron Emission Tomography

Undergo FDG-PET

Radiation Therapy

Undergo MDRT

Primary outcome measure

  • Progression free survival (PFS) (Cohort 1) [ Time Frame: From randomization to first radiographic or prostate-specific antigen (PSA)-based disease progression, or death, assessed up to 36 months ]
  • Complete response rate (Cohort 2) [ Time Frame: At 6 months ]

Central Contacts and Locations

Central contacts

Study Coordinator

13126959367cancer@northwestern.edu

Locations

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

David VanderWeele

312-926-2413david.vanderweele@northwestern.edu

Principal Investigator:

David VanderWeele

Northwestern Medicine: Kishwaukee

Recruiting

DeKalb, Illinois, United States, 60115

Contacts

Study Coordinator

3126951301cancer@northwestern.edu

Principal Investigator:

David VanderWeele, MD, PHD

Northwestern Medicine: Delnor

Recruiting

Geneva, Illinois, United States, 60134

Contacts

Study Coordinator

3126951301cancer@northwestern.edu

Principal Investigator:

David VanderWeele, M

Northwestern University Oak Brook IL453

Recruiting

Oak Brook, Illinois, United States, 60523

Contacts

Study Coordinator, MD, PhD

(331) 732-4490cancer@northwestern.edu

Principal Investigator:

David VanderWeele, MD, PhD

Northwestern Medicine: Warrenville

Recruiting

Warrenville, Illinois, United States, 60555

Contacts

Study Coordinator

3126951301cancer@northwestern.edu

Principal Investigator:

David VanderWeele, MD, PhD

More Information

Sponsor

Northwestern University

Last update posted

Mar 30, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Northwestern University on 2026-03-30.