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NCT Number: NCT04302454

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Radiotherapiegroep, Arnhem, Gelderland, Netherlands

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Radiotherapy

Radiation

Radiotherapy

Other names: MDRT, Metastase-directed radiotherapy, SBRT, Stereotactic body radiotherapy

leuprorelin

Drug

Hormonal therapy

Other names: Eligard

Primary outcomes

  1. Metastases progression-free survival (MPFS)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Collaborators

  • Dutch Cancer Society

Registry information

Acronym: ADOPT

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Mar 10, 2020
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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