Radiation therapy for metastatic prostate cancer treatment

Metastasis-directed Radiotherapy (MDRT) for Men With De-novo Oligometastatic Prostate Cancer Treated With Long-term Androgen Deprivation Therapy in the STAMPEDE Trial (METANOVA)

This study tests if adding a targeted radiation treatment to standard hormone therapy can help people with newly diagnosed metastatic prostate cancer have better control over their disease.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: Case Comprehensive Cancer Center (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 2 sites (Cleveland, Ohio and 1 other locations)
• Trial ID: NCT06150417 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of metastasis-directed radiotherapy (MDRT) in patients with newly diagnosed metastatic prostate cancer. Participants will receive standard androgen deprivation therapy (ADT) for 12 months, along with either local therapy such as radical prostatectomy or radiotherapy. A portion of participants will be randomized to receive MDRT targeting areas where the cancer has spread. The goal is to determine if adding MDRT improves disease control compared to standard treatment alone.

Who should consider this trial

Good fit: Ideal candidates are men aged 18 and older with newly diagnosed prostate adenocarcinoma and evidence of oligometastatic disease.

Not a fit: Patients with extensive metastatic disease or those who have received prior treatment for prostate cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to better disease control and improved outcomes for patients with metastatic prostate cancer.

How similar studies have performed: Previous studies have shown promising results with local therapies in oligometastatic prostate cancer, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* Participant must be ≥ 18 years of age.
* Participant must have an ECOG performance status ≤ 1.
* Histologic confirmation of prostate adenocarcinoma of the prostate gland, with evidence of metastasis on imaging by conventional imaging (MRI, CT, or 99mTc bone scan) or PSMA PET/CT. Biopsy of sites of metastasis is strongly encouraged, but not required.

  * There must be at least 10-15 unstained slides from 2 cores of the highest tumor cellularity available.
* Newly diagnosed disease with no prior treatment(surgery, radiation or systemic treatment, ie hormone therapy or chemotherapy) to the primary disease.

  * Participants may have started LHRH agonist or antagonist therapy, and/or androgen receptor signaling inhibitor (ARSI) as long as it was not started more than 30 days before the participant is enrolled on this study.
* In participants who undergo only conventional imaging, oligometastatic disease is defined as 1-5 discrete metastatic sites in the bone and/or extra-pelvic lymph node (LN) stations.

  * Extra-pelvic LN stations are superior to the regional/pelvic LN stations. Pelvic LN stations commence at the bifurcation of the aorta and bifurcation of the proximal inferior vena cava to the common iliac veins.

    * Radiographic criteria for a LN to be considered a metastatic focus is defined as short-axis diameter in the axial plane of ≥ 1.0 cm, with irregular border and/or heterogeneous morphology
* In participants who undergo PSMA PET/CT (in the presence or absence of conventional imaging), oligometastatic disease is defined as 1-10 PSMA avid bone lesions and/or extra-pelvic LN stations. The MI-RADS reporting system will be followed to guide PSMA PET interpretation

  * In participants extra-pelvic nodal (M1a) disease only by PSMA PET/CT and M0 by conventional imaging (i.e. extra-pelvic LN did not meet size criteria by CT), participant must meet 2 of 3 following criteria in order to be eligible:

    * 1\. PSA ≥ 40
    * 2\. Evidence of cN1 disease (pelvic LN)
    * 3\. Decipher score ≥ 0.89
* Adequate organ and marrow function to receive treatment per treating physician
* Medically fit for treatment and agreeable to follow-up.
* Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

Participants with the presence of any of the following:

* Castration resistant prostate cancer (CRPC).
* Evidence of visceral or intracranial metastases.
* Participant receiving any other investigational agents for cancer.
* Participant is participating in a concurrent treatment protocol for cancer.
* Unable to lie flat during or tolerate PET/MRI, PET/CT or SBRT.
* Prior definitive treatment to the primary prostate cancer or pelvis.
* Participant with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled diabetes (HgA1c \> 10), active pituitary or adrenal dysfunction, or psychiatric illness/social situations that would limit compliance with study requirements
* History of another active malignancy within the previous 2 years, except for non-melanoma skin cancer, non-muscle invasive bladder cancer, or a malignancy that is considered cured with minimal risk of recurrence
* Active Crohn's disease or ulcerative colitis despite medical management.
* Refusal to sign informed consent.
* Any condition that in the opinion of the investigator would preclude participation in this study

Where this trial is running

Cleveland, Ohio and 1 other locations

• University Hospitals Cleveland Medical Center Seidman Cancer Center — Cleveland, Ohio, United States (Recruiting)
• Carbone Cancer Center University of Wisconsin-Madison — Madison, Wisconsin, United States (Recruiting)

Study contacts

• Principal investigator: Angela Y Jia, MD, PhD — University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
• Study coordinator: Angela Y Jia, MD, PhD

Conditions Prostate Cancer; Malignant Neoplasm of Prostate; Secondary Malignant Neoplasm of Prostate; Metastasis-directed Radiotherapy