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

Study Overview
=================
Brief Summary
-----------------
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.

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

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Radiation: Radiotherapy
* Drug: Leuprorelin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Histologically proven initial diagnosis of adenocarcinoma of the Prostate. 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). Minimal 1 lesion and maximum 4 lesions (bone + lymph nodes) in total, without evidence of visceral metastases. 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. Nodal relapse (M1a) on PSMA-PET/CT above the aortic bifurcation with a maximum of 3 positive lymph nodes. Bone relapse on PSMA-PET/CT with a maximum of 3 lesions. Combination of a, b, c with a maximum of 4 metastases. Age > 18 years. Recent PSMA-PET/CT scan within 60 days prior to randomization. PSA < 10 ng/ml. In case of chronic use of finasteride the PSA value should be < 5 ng/ml. WHO performance state 0-2. Signed informed consent prior to registration/randomization. Exclusion criteria Visceral metastases. PSA ≥ 10 ng/ml. PSA-doubling time ≤ 3 months. ADT or chemotherapy for recurrent PCa. Testosterone < 1.7 nmol/l Painful metastases needed pain medication (> level 1 pain medication) . Invasive active cancers other than superficial non-melanoma skin cancers. Inability or unwillingness to understand the information on trial-related topics, to give informed consent or to fill out QoL questionnaires.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Multicentre, randomized study. A total of 280 patients will participate in this study, equally divided between both study groups
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Radiotherapy without hormonal therapy<br>Metastase-directed radiotherapy without the addition of hormonal therapy | Radiation: Radiotherapy<br>* Radiotherapy<br>* Other names: Stereotactic body radiotherapy;|
| Experimental: Radiotherapy combined with hormonal therapy<br>Metastase-directed radiotherapy with the addition of of short-term hormonal therapy (6 months) | Radiation: Radiotherapy<br>* Radiotherapy<br>* Other names: Stereotactic body radiotherapy;Drug: Leuprorelin<br>* Hormonal therapy<br>* Other names: Eligard;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metastases progression-free survival (MPFS) | The primary aim of this project is to test the hypothesis that the addition of ADT to MDRT in well-selected PCa patients with oligo-metastatic disease (OM) prolongs the metastases progression-free survival (MPFS) compared to MDRT alone | 2.5 years after treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prostate cancer, Oligometastasis, Stereotactic Body Radiation Therapy, Androgen Deprivation Therapy, Biochemical recurrence, PSMA PET/CT, Metastases-directed radiotherapy, Metastases progression-free survival