Radiation therapy for metastatic prostate cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Memorial Sloan Kettering Cancer Center
  New York, New York, United States Recruiting
• 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
• Email: Angela.Jia@UHhospitals.org
• Phone: 216-844-3262

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Targeted alpha therapy for B7-H3 expressing solid tumors using AKY-2519

  This phase 1b trial tests a radiolabeled drug (AKY-2519) to see if it's safe and tolerable in adults with B7-H3 positive advanced solid tumors, including NSCLC and SCLC, with imaging to help guide use.

  Recruiting at 2 sites Phase 1 Aktis Oncology, Inc. · Miami, Florida and 1 other locations · NCT07887971

• PSMA-guided surgery and tissue-resident T cells in node-positive prostate cancer

  This study tests whether PSMA-guided surgery can help identify and study tissue-resident T cells in prostate cancer that has spread to lymph nodes.

  Recruiting Niguarda Hospital · Milan, Lombardy · NCT07879820

• Predictive factors for response to Lu-177 PSMA therapy in metastatic castration-resistant prostate cancer

  This study tests whether imaging, dose measurements, and blood tests can predict which men with metastatic castration-resistant prostate cancer will respond to Lu-177 PSMA therapy.

  Recruiting Lithuanian University of Health Sciences · Kaunas · NCT07863986

• Salvage high-dose-rate brachytherapy for locally recurrent prostate cancer

  This observational study tests whether salvage HDR brachytherapy can help men with locally recurrent prostate cancer after initial radiotherapy, using advanced imaging and biopsy to guide treatment.

  Recruiting at 8 sites Instituto de Investigación en Oncología Radioterápica - Fundación Española de Oncología Radioterápic · Benidorm, Alicante and 9 other locations · NCT07860528

• Multi-peptide Vaccination and PSMAxCD3 Antibody Therapy for Prostate Cancer with Biochemical Recurrence

  This phase 2 trial tests whether a PSMA-targeted bispecific antibody (CC-1), a prostate cancer peptide vaccine (VAC-XS15-PC01), or both can be given safely and help control biochemical recurrence after local therapy in men with prostate cancer.

  Recruiting Phase 2 University Hospital Tuebingen · Heidelberg, Baden-Wurttemberg and 3 other locations · NCT07860047

• Lutetium-177 Ludotadipep for advanced prostate cancer

  This study tests whether adding Lu-177 Ludotadipep to standard care helps men with metastatic castration-resistant prostate cancer live longer without their disease getting worse.

  Recruiting at 7 sites Phase 3 FutureChem · Gyeonggi-do and 7 other locations · NCT07853209

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.