Long-term Better Than Short-term ADT With Salvage RT

Launched by UNIVERSITAIRE ZIEKENHUIZEN KU LEUVEN · Jan 24, 2020

Keywords

ClinConnect Summary

**Trial Summary: Long-term Better Than Short-term ADT With Salvage RT**

This clinical trial is looking at the best way to treat prostate cancer that has returned after surgery. Specifically, it compares two treatment approaches: one group will receive long-term hormone therapy (called ADT) combined with high-dose radiation, while the other group will get the same radiation but with a shorter course of hormone therapy. The goal is to see which approach helps patients live longer without their cancer spreading to other parts of the body.

To participate in this trial, men must have had prostate cancer surgery and now have an increase in a blood marker called PSA, which indicates the cancer may be returning. Key eligibility criteria include being asymptomatic with a specific PSA level (at least 0.2 ng/l) and having certain testosterone levels. Participants can expect to receive careful monitoring and support throughout their treatment. It's important to note that this trial is currently recruiting participants and aims to provide new insights into the best treatment strategies for prostate cancer recurrence.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • History of histologically proven prostate cancer, treated with RP and ePLND. All patients have to be pN0. The minimal template for ePLND is defined as the removal of the external iliac, internal iliac and obturator nodes (standard template). Removal of the presacral and common iliac nodes is left at the discretion of the treating urologist.
• • Asymptomatic PSA-rise post-RP, defined as a value equal to or more than 0.2µg/l and at least confirmed once (interval ≥2 weeks, confirmation PSA level should be higher). In case of Gleason 8-10, pT3b or R1 resection, an asymptomatic PSA-rise post-RP starting from ≥0.15 µg/l is allowed for inclusion. If the PSA-level is less than 0.4 ng/ml, no additional staging for distant metastasis is required before inclusion in the trial. The patient will be offered the opportunity to participate in a diagnostic sub-study with investigational imaging with 18F PSMA PET CT. However in case of PSA-level \>0.4 ng/ml, biological imaging using 18F-PSMA or 68Ga-PSMA is mandatory as this is not considered investigational anymore. Therefore the patient cannot anymore take part in the diagnostic sub-study and (un-blinded) PET-CT is obligatory to rule out lymph node (N) and /or distant metastasis (M1a-c) before inclusion.
• • Testosterone levels within above 150 ng/dl.
• • ECOG 0-1
• • Life expectancy more than 5 years
• • Signed informed consent
• Exclusion Criteria:
• • Presence of pN1 disease at original surgical specimen.
• • Presence of distant metastasis at time of referral (M1a-c). If PSA more than 0.4 ng/ml, imaging with PET-CT is required to rule out distant metastasis (see above). Other additional imaging modalities (CT scan, bone scintigraphy...) are allowed but left at the discretion of the treating centre.
• • Undetectable PSA (less than 0.2 ng/ml) at time of referral.
• • Previous RT making new RT impossible (overlapping treatment fields).
• • Known contraindications to irradiation (Ulcerative Colitis, Crohn Disease, Ataxia Teleangiectasia...)
• • Active treatment with ADT or PSA modulating drugs (finasteride, dutasteride, high-dose corticoids...)
• • Not able understanding treatment protocol or signing informed consent.