Radiotherapy and Androgen Deprivation In Combination After Local Surgery (RADICALS) Translational Study

Launched by UNIVERSITY COLLEGE, LONDON · Nov 16, 2023

Keywords

ClinConnect Summary

The RADICALS Translational Study is looking at how certain biomarkers (which are substances in the body that can indicate disease) can help doctors decide which men with prostate cancer might benefit most from a specific treatment. This study focuses on men who have already had surgery to remove their prostate and are being treated with a combination of hormone therapy (known as androgen deprivation therapy) and radiation therapy. By analyzing tumor samples from men who participated in earlier studies, researchers hope to identify which patients are more likely to respond positively to this combined treatment.

To be eligible for this study, men must have a diagnosis of nonmetastatic prostate cancer (meaning the cancer hasn't spread), have had their prostate removed, and show low levels of a protein called PSA in their blood after surgery. They should not have experienced any significant rises in PSA levels that indicate a return of the cancer. It's important that they have consented to allow their tumor samples to be used for research. Participants will not be asked to undergo new treatments, but their previous samples will provide valuable information to help guide future prostate cancer therapies.

Gender

MALE

Eligibility criteria

• DISEASE CHARACTERISTICS:
• Inclusion criteria:
• • Diagnosis of nonmetastatic adenocarcinoma of the prostate Must have undergone radical prostatectomy Post-operative serum prostate-specific antigen (PSA) \< 0.4 ng/mL No post-operative biochemical failure, defined as EITHER two consecutive rises in PSA and final PSA \> 0.1 ng/mL OR three consecutive rises in PSA (for patients undergoing hormone therapy duration randomization)
• Exclusion criteria:
• • Known distant metastases from prostate cancer PSA \> 5 ng/mL at the time of hormone randomization (for patients undergoing hormone therapy duration randomization)
• PATIENT CHARACTERISTICS:
• • No other active malignancy likely to interfere with protocol treatment or follow-up.
• • Consent has been given within the RADICALS (RT/HD) trial to translational research and follow up.
• PRIOR CONCURRENT THERAPY:
• Inclusion criteria:
• • See Disease Characteristics Co-enrollment to other trials is permitted, providing this does not interfere with the outcome measures 5-α reductase inhibitors, soya, selenium, and vitamin E are acceptable non-trial therapies
• Exclusion criteria:
• • Prior hormone therapy Bilateral orchidectomy Prior pelvic radiotherapy Neoadjuvant treatment Other concurrent therapies for prostate cancer (e.g., estrogens or cytotoxic chemotherapy) prior to disease progression