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

April 1, 2025 updated by: University Medical Center Groningen
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

280

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Groningen, Netherlands
        • UMCG
      • Tilburg, Netherlands
        • Verbeeten Institute
    • Friesland
      • Leeuwarden, Friesland, Netherlands
        • Radiotherapy Institute Friesland
    • Gelderland
      • Arnhem, Gelderland, Netherlands
        • Radiotherapiegroep
      • Nijmegen, Gelderland, Netherlands
        • Radboud University Medical Center
    • Limburg
      • Maastricht, Limburg, Netherlands
        • Maastro Clinic
    • Noord-Brabant
      • Eindhoven, Noord-Brabant, Netherlands
        • Catharina Hospital
    • Noord-Holland
      • Amsterdam, Noord-Holland, Netherlands
        • Amsterdam UMC (Location VUmc)
    • Overijssel
      • Deventer, Overijssel, Netherlands
        • Radiotherapiegroep
      • Zwolle, Overijssel, Netherlands
        • Isala
    • Zuid-Holland
      • Den Haag, Zuid-Holland, Netherlands
        • Haga hospital
      • Leiden, Zuid-Holland, Netherlands
        • Leinden University Medical Center
      • Rotterdam, Zuid-Holland, Netherlands
        • Erasmus Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Radiotherapy without hormonal therapy
Metastase-directed radiotherapy without the addition of hormonal therapy
Radiation: Radiotherapy
Radiotherapy
Other Names:
  • SBRT
  • Stereotactic body radiotherapy
  • MDRT
  • Metastase-directed radiotherapy
Experimental: Radiotherapy combined with hormonal therapy
Metastase-directed radiotherapy with the addition of of short-term hormonal therapy (6 months)
Radiation: Radiotherapy
Radiotherapy
Other Names:
  • SBRT
  • Stereotactic body radiotherapy
  • MDRT
  • Metastase-directed radiotherapy
Drug: Leuprorelin
Hormonal therapy
Other Names:
  • Eligard

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2.5 years after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Center Groningen

Collaborators

Dutch Cancer Society

Investigators

  • Principal Investigator: S. Al-Uwini, PhD, UMCG

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 19, 2020

Primary Completion (Estimated)

October 21, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

March 6, 2020

First Submitted That Met QC Criteria

March 6, 2020

First Posted (Actual)

March 10, 2020

Study Record Updates

Last Update Posted (Actual)

April 4, 2025

Last Update Submitted That Met QC Criteria

April 1, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RT2019-13

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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