Clinical trial NCT04302454: Androgen Deprivation Therapy for Oligo-recurrent Prostate Cancer in Addition to radioTherapy
Official title: Androgen Deprivation Therapy for Oligo-recurrent Prostate Cancer in Addition to radioTherapy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Prostate Cancer
Keywords: Prostate cancer
Oligometastasis
Stereotactic Body Radiation Therapy
Androgen Deprivation Therapy
Biochemical recurrence
PSMA PET/CT
Metastases-directed radiotherapy
Metastases progression-free survival
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
Collaborators: name: Dutch Cancer Society
First posted: 2020-03-10
Enrollment: 280
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicentre, randomized study. A total of 280 patients will participate in this study, equally divided between both study groups
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Metastases progression-free survival (MPFS)
timeFrame: 2.5 years after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Leeuwarden
country: Netherlands
facility: Radiotherapy Institute Friesland
state: Friesland
city: Arnhem
country: Netherlands
facility: Radiotherapiegroep
state: Gelderland
city: Nijmegen
country: Netherlands
facility: Radboud University Medical Center
state: Gelderland
city: Maastricht
country: Netherlands
facility: Maastro Clinic
state: Limburg
city: Eindhoven
country: Netherlands
facility: Catharina Hospital
state: Noord-Brabant
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC (Location VUmc)
state: Noord-Holland
city: Deventer
country: Netherlands
facility: Radiotherapiegroep
state: Overijssel
city: Zwolle
country: Netherlands
facility: Isala
state: Overijssel
city: Den Haag
country: Netherlands
facility: Haga Hospital
state: Zuid-Holland
city: Leiden
country: Netherlands
facility: Leinden University Medical Center
state: Zuid-Holland
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
state: Zuid-Holland
city: Groningen
country: Netherlands
facility: UMCG
city: Tilburg
country: Netherlands
facility: Verbeeten Institute
Study officials:
affiliation: UMCG
name: S. Al-Uwini, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Janssen J, Staal FHE, Brouwer CL, Langendijk JA, de Jong IJ, van Moorselaar RJA, Schuit E, Verzijlbergen JF, Smeenk RJ, Aluwini S. Androgen Deprivation therapy for Oligo-recurrent Prostate cancer in addition to radioTherapy (ADOPT): study protocol for a randomised phase III trial. BMC Cancer. 2022 May 2;22(1):482. doi: 10.1186/s12885-022-09523-2.