What is this trial studying for metastatic prostate cancer?

This trial is studying whether adding targeted radiotherapy or a radioactive drug to the best standard hormone treatments can slow the spread of metastatic prostate cancer and improve survival. The research is led by University College London and involves comparing these new approaches with usual care to better understand their effects for patients.

Who may be eligible for this metastatic prostate cancer clinical trial?

Men aged 18 or older with prostate cancer that has spread to bones, lymph nodes, or other organs and who have started or plan to start hormone therapy for at least 2 years may be eligible. Good overall health and willingness to follow trial treatments are also needed. Please review eligibility criteria for more details.

Is there any cost to participate in this metastatic prostate cancer clinical trial?

Study-related care, including the study treatments and all trial visits, is provided at no cost. However, personal travel and other expenses may vary and are not guaranteed to be covered. Participants should be prepared for potential out-of-pocket costs related to travel.

Actively Recruiting

Phase 3

Age: 18Years +

MALE

ID06320067

Studying Treatments in Patients Receiving Androgen Deprivation Therapy for Metastatic Prostate Cancer Evaluation of Drug and Radiation Efficacy in a Multi-arm Randomised Controlled Trial STAMPEDE2

Led by University College, London · Updated on 2025-09-26

3360

Participants Needed

Research Sites

47 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating two new treatments compared to the best standard care for men with prostate cancer that has spread to other parts of the body and still responds to hormone therapy. This phase 3 trial includes multiple hospitals across the UK and is led by University College London. The study aims to see if adding targeted radiotherapy or a radioactive drug can slow cancer spread and improve survival. Participants are assigned by computer to one of several groups. One group receives standard care, which includes androgen deprivation therapy ADT plus other hormone therapies, possible chemotherapy with docetaxel, and local radiotherapy. Another group receives standard care plus targeted high-dose radiotherapy SABR to metastatic sites. A third group receives standard care plus a radioactive therapy called 177Lu-PSMA-617, given in cycles with two doses per cycle. Treatments continue unless side effects are severe or participants choose to stop. During the study, participants will have scans and tests to monitor their cancer and side effects. Doctors will check safety and treatment adherence over time. Researchers will measure overall survival, failure-free survival, progression-free survival, prostate cancer-specific survival, and quality of life up to 10 years from randomization. Safety will be closely monitored, and participants health will be followed during and after treatment.

CONDITIONS

Brief Title

A Randomised Controlled Platform Trial Testing Treatments in Metastatic Hormone Sensitive Prostate Cancer

Who Can Participate

Age: 18Years +

MALE

Eligibility Criteria

You may qualify if you...

At least 18 years old
Histological confirmation or strong clinical suspicion of prostate adenocarcinoma
Confirmed metastatic sites on CT/MRI and bone or PET scans including bone, non-regional lymph nodes, or visceral metastases
Newly diagnosed or relapsed hormone-sensitive metastatic prostate cancer with completed hormone treatments at least 2 years prior and total ADT duration up to 3 years
Started or intend to start long-term ADT for minimum of 2 years
WHO Performance Status 0-2, or 3 if due to metastatic burden expected to improve with ADT
Willing and able to comply with trial treatments
Signed informed consent for trial registration

You will not qualify if you...

Small cell carcinoma of prostate
Brain or leptomeningeal metastatic disease
Active other malignancies progressing or treated in last 36 months except certain low-risk cancers
Any medical condition making participant unfit or unsuitable for long-term ADT or trial treatments
For SABR comparison: relapsed cancer, prior radical prostate treatment, intracranial metastases, prior treatment to metastatic site, urgent neurological conditions requiring immediate therapy, conditions preventing radiotherapy delivery or planning, inflammatory bowel disease, connective tissue disorders, or certain lung diseases
For 177Lu-PSMA-617 comparison: prior radionuclide therapies like Strontium-89 or Radium-223, symptomatic or impending cord compression, inability to raise arms, unmanageable urinary problems, MRI contraindications for imaging sub-study

Research Team

Pamela Niem

Aaron Horsey

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