Androgen Deprivation Therapy for Oligo-recurrent Prostate Cancer in Addition to radioTherapy

RT2019-13

The overall aim of this project is to test the hypothesis that the addition of ADT to metastasis-directed radiotherapy (MDRT) in well-selected PCa patients with oligo-metastatic disease prolongs the metastases progression-free survival (MPFS) compared to MDRT alone.

2020-03-19

2024-12-01

2024-12-01

Recruiting

Early phase I

280

Inclusion criteria: 1. Histologically proven initial diagnosis of adenocarcinoma of the Prostate. 2. Biochemical recurrence of prostate cancer following primary local prostate treatment (radical prostatectomy, primary radiotherapy or radical prostatectomy +/- prostate bed adjuvant salvage radiotherapy) according to the EAU guidelines 2018. BCR after surgery: PSA \> 0.1ng/ml. BCR after radiotherapy: PSA nadir +2 ng/ml or 3 consequent rises in PSA level (after exclusion of possible bounce effect). 3. Minimal 1 lesion and maximum 4 lesions (bone + lymph nodes) in total, without evidence of visceral metastases. 1. Nodal relapse (N1) in the pelvis on PSMA-PET/CT with a maximum of 4 positive lymph nodes. The upper limit of the pelvis is defined as the aortic bifurcation. 2. Nodal relapse (M1a) on PSMA-PET/CT above the aortic bifurcation with a maximum of 3 positive lymph nodes. 3. Bone relapse on PSMA-PET/CT with a maximum of 3 lesions. 4. Combination of a, b, c with a maximum of 4 metastases. 4. Age \> 18 years. 5. Recent PSMA-PET/CT scan within 60 days prior to randomization. 6. PSA \< 10 ng/ml. 7. In case of chronic use of finasteride the PSA value should be \< 5 ng/ml. 8. WHO performance state 0-2. 9. Signed informed consent prior to registration/randomization. Exclusion criteria 1. Visceral metastases. 2. PSA ≥ 10 ng/ml. 3. PSA-doubling time ≤ 3 months. 4. ADT or chemotherapy for recurrent PCa. 5. Testosterone \< 1.7 nmol/l 6. Painful metastases needed pain medication (\> level 1 pain medication) . 7. Invasive active cancers other than superficial non-melanoma skin cancers. 8. Inability or unwillingness to understand the information on trial-related topics, to give informed consent or to fill out QoL questionnaires.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Multicentre, randomized study. A total of 280 patients will participate in this study, equally divided between both study groups', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 280, 'type': 'ESTIMATED'}}

2024-02-28