Status:
ACTIVE_NOT_RECRUITING
Androgen Deprivation Therapy for Oligo-recurrent Prostate Cancer in Addition to radioTherapy
Lead Sponsor:
University Medical Center Groningen
Collaborating Sponsors:
Dutch Cancer Society
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE3
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 m...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
March 19 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
280 Patients enrolled
Trial Details
Trial ID
NCT04302454
Start Date
March 19 2020
End Date
December 1 2027
Last Update
April 4 2025
Active Locations (13)
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1
Radiotherapiegroep
Arnhem, Gelderland, Netherlands
2
Radboud University Medical Center
Nijmegen, Gelderland, Netherlands
3
Maastro Clinic
Maastricht, Limburg, Netherlands
4
Catharina Hospital
Eindhoven, North Brabant, Netherlands