Prostate Cancer Clinical Trial
— ADOPTOfficial title:
Androgen Deprivation Therapy for Oligo-recurrent Prostate Cancer in Addition to radioTherapy
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.
Status | Recruiting |
Enrollment | 280 |
Est. completion date | December 1, 2024 |
Est. primary completion date | December 1, 2024 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Netherlands | Amsterdam UMC (Location VUmc) | Amsterdam | Noord-Holland |
Netherlands | Radiotherapiegroep | Arnhem | Gelderland |
Netherlands | Haga Hospital | Den Haag | Zuid-Holland |
Netherlands | Radiotherapiegroep | Deventer | Overijssel |
Netherlands | Catharina Hospital | Eindhoven | Noord-Brabant |
Netherlands | UMCG | Groningen | |
Netherlands | Radiotherapy Institute Friesland | Leeuwarden | Friesland |
Netherlands | Leinden University Medical Center | Leiden | Zuid-Holland |
Netherlands | Maastro Clinic | Maastricht | Limburg |
Netherlands | Radboud University Medical Center | Nijmegen | Gelderland |
Netherlands | Erasmus Medical Center | Rotterdam | Zuid-Holland |
Netherlands | Verbeeten Institute | Tilburg | |
Netherlands | Isala | Zwolle | Overijssel |
Lead Sponsor | Collaborator |
---|---|
University Medical Center Groningen | Dutch Cancer Society |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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