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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04302454

Acronym

ADOPT

Enrollment

280

Registered

2020-03-10

Start date

2020-03-19

Completion date

2027-12-01

Last updated

2025-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

RADIATIONRadiotherapy

Radiotherapy

DRUGLeuprorelin

Hormonal therapy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Multicentre, randomized study. A total of 280 patients will participate in this study, equally divided between both study groups

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Metastases progression-free survival (MPFS)	2.5 years after treatment	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

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026