Immediate Curative vs Conservative Treatment in Older Men With M0, High-risk Prostate Cancer

Launched by SVEN LÖFFELER · Jul 2, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the best treatment options for older men (75 years and older) with high-risk prostate cancer that has not spread to other parts of the body. Researchers want to find out if immediate treatments, like surgery or radiation, are as beneficial for these older patients as they are for younger ones, or if the side effects of these treatments are too much to handle. Participants will be randomly assigned to either receive immediate treatment or to follow a more conservative approach that focuses on managing their symptoms and overall health.

To be eligible for this study, men must be at least 75 years old, in generally good health, and recently diagnosed with prostate cancer that is considered aggressive. They need to be able to understand and complete health questionnaires to help track their quality of life during the trial. Participants can expect to be monitored closely and will have opportunities to share their experiences and outcomes, helping researchers understand the impact of these treatment choices on older patients.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Participant must be 75 years of age or older, at the time of signing the informed consent.
• • 2. Participants who are healthy as determined by medical evaluation and geriatric G8/ miniCOGTM evaluation (G8: Fit, score \>14, or reversibly frail; miniCOGTM: score \>2)
• And who have PCa (diagnosed ≤6 months) with one or both of the following features:
• • Gleason grade 8-10 (ISUP group 4 and 5) other than microscopic, low-volume disease (tumor must be either palpable or visible on MRI, i.e., PIRADS 4 or 5)
• • Locally advanced PCa (T3 or T4) (unequivocal findings of clinical/ radiological T3 or clinical/ radiological T4 on DRE or MRI; broad capsular contact of tumor on MRI is treated as localized disease, T2, in the context of this study)
• • Able to read, understand and fill in HRQoL questionnaires (PROMS)
• • 3. Male
• • 4. Capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
• Exclusion Criteria:
• • Medical Conditions
• • 1. Dementia (unable to consent) Prior/Concomitant Therapy
• • 2. Prior radiation to the pelvis
• • 3. Hormone therapy \>3 months prior to randomization Diagnostic assessments
• • 4. Lymph node metastasis (N0) on MRI, CT or PSMA-PET CT (equivocal N-findings =N0; borderline cases will be discussed and called by a study tumor board).
• • 5. Distant metastasis (M0) on MRI, CT, bone scan or PSMA-PET CT (equivocal bone scan findings need to be confirmed with MRI or CT; borderline cases will be discussed by a study tumor board).
• • Other Exclusions
• • 6. Disabled or severe comorbidity (identified by G8 screening)
• • 7. Unable to read, understand or fill out HRQoL questionnaires (PROMS)