Short Versus Long-term Androgen Deprivation Therapy With Salvage Radiotherapy in Prostate Cancer. URONCOR 0624

Launched by INSTITUTO DE INVESTIGACIÓN EN ONCOLOGÍA RADIOTERÁPICA - FUNDACIÓN ESPAÑOLA DE ONCOLOGÍA RADIOTERÁPIC · Mar 10, 2023

Keywords

ClinConnect Summary

This clinical trial, called URONCOR 0624, is studying the best duration of hormone therapy, known as Androgen Deprivation Therapy (ADT), for men with prostate cancer who are experiencing biochemical recurrence (BCR) after surgery. BCR means that the prostate-specific antigen (PSA) levels in the blood have risen after surgery, indicating that the cancer might not be completely gone. The trial aims to compare the effects of short-term ADT (6 months) versus long-term ADT (2 years) when combined with salvage radiotherapy, a treatment aimed at controlling cancer that has returned.

To participate in this trial, patients must have been diagnosed with prostate cancer, have undergone surgery to remove the prostate, and have experienced BCR with specific PSA levels. Eligible patients will be closely monitored and may receive either of the two treatment durations. This study is especially important because it could help doctors better understand how long men with certain risk factors should receive hormone therapy after surgery, potentially improving their chances of staying cancer-free longer. If you're considering joining, you would need to meet certain health criteria and agree to participate in the study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients with histologically-confirmed prostate cancer treated with radical prostatectomy. Patients who have not undergone lymph node dissection are eligible for inclusion.
• • 2. Biochemical recurrence after prostatectomy: BCR is defined as a PSA value ≥ 0.2 ng/mL, with at least one confirmatory PSA determination ≥ two weeks after the first test (the confirmatory PSA level must be higher than the initial value). Patients with Gleason 8-10, pT3b or R1 are eligible for inclusion in the trial with PSA ≥ 0.15 ng/mL; however, in patients with PSA \> 0.4 ng/mL, imaging tests (conventional CT and bone scans or advanced imaging techniques such as PSMA or choline PET/CT) should be performed to check for metastases. In patients with PSA levels between 0.15 and 0.4 ng/mL, no further tests are required to check for distant metastases prior to inclusion.
• 3. Intermediate and high-risk patients according to the classification criteria proposed by González San Segundo et al. (18):
• • CHARACTERISTICS INTERMEDIATE RISK (≥ 2) HIGH RISK(≥ 1)
• • PSA at diagnosis, ng/mL 0.6-1.0 ≥1.0 PSA doubling time, months 6-12 \< 6 GLEASON / ISUP 7/3 ≥8/≥4 TNM (prostatectomy specimen) pT2-3a pN0-Mx pT3b pN0-Mx Time to biochemical recurrence, months \>18 \<18 Margins Positive Positive
• • 4. Testosterone level \> 150 ng/dL at inclusion
• • 5. ECOG 0-1
• • 6. Life expectancy \> 5 years
• • 7. Signed informed consent
• Exclusion Criteria:
• • 1. Presence of pN1 disease in the original surgical specimen
• • 2. Presence of macroscopic disease on imaging tests. If the PSA at diagnosis is \> 0.4 ng/mL, then imaging tests (CT and bone scan and/or PET/CT or body magnetic resonance imaging \[MRI\]) are required.
• • 3. PSA \<0.2 or \<0.15 ng/mL (if Gleason score=10, pT3b, or R1 in the radical prostatectomy specimen).
• • 4. Previous pelvic radiotherapy
• • 5. Radiotherapy contraindicated
• • 6. Ongoing treatment with ADT or PSA-modulating drugs (e.g., finasteride, dutasteride, high dose steroids)
• • 7. Inability to understand the treatment protocol or sign informed consent