search
Back to results

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

Primary Purpose

Prostate Cancer

Status
Recruiting
Phase
Phase 3
Locations
Netherlands
Study Type
Interventional
Intervention
Radiotherapy
Leuprorelin
Sponsored by
University Medical Center Groningen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate cancer, Oligometastasis, Stereotactic Body Radiation Therapy, Androgen Deprivation Therapy, Biochemical recurrence, PSMA PET/CT, Metastases-directed radiotherapy, Metastases progression-free survival

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept 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.

Sites / Locations

  • Radiotherapy Institute FrieslandRecruiting
  • RadiotherapiegroepRecruiting
  • Radboud University Medical CenterRecruiting
  • Maastro ClinicRecruiting
  • Catharina HospitalRecruiting
  • Amsterdam UMC (Location VUmc)
  • RadiotherapiegroepRecruiting
  • IsalaRecruiting
  • Haga HospitalRecruiting
  • Leinden University Medical CenterRecruiting
  • Erasmus Medical Center
  • UMCGRecruiting
  • Verbeeten Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Radiotherapy without hormonal therapy

Radiotherapy combined with hormonal therapy

Arm Description

Metastase-directed radiotherapy without the addition of hormonal therapy

Metastase-directed radiotherapy with the addition of of short-term hormonal therapy (6 months)

Outcomes

Primary Outcome Measures

Metastases progression-free survival (MPFS)
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

Secondary Outcome Measures

Full Information

First Posted
March 6, 2020
Last Updated
April 5, 2022
Sponsor
University Medical Center Groningen
Collaborators
Dutch Cancer Society
search

1. Study Identification

Unique Protocol Identification Number
NCT04302454
Brief Title
Androgen Deprivation Therapy for Oligo-recurrent Prostate Cancer in Addition to radioTherapy
Acronym
ADOPT
Official Title
Androgen Deprivation Therapy for Oligo-recurrent Prostate Cancer in Addition to radioTherapy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 19, 2020 (Actual)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Center Groningen
Collaborators
Dutch Cancer Society

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Multicentre, randomized study. A total of 280 patients will participate in this study, equally divided between both study groups
Masking
None (Open Label)
Allocation
Randomized
Enrollment
280 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Radiotherapy without hormonal therapy
Arm Type
Active Comparator
Arm Description
Metastase-directed radiotherapy without the addition of hormonal therapy
Arm Title
Radiotherapy combined with hormonal therapy
Arm Type
Experimental
Arm Description
Metastase-directed radiotherapy with the addition of of short-term hormonal therapy (6 months)
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Other Intervention Name(s)
MDRT, Metastase-directed radiotherapy, SBRT, Stereotactic body radiotherapy
Intervention Description
Radiotherapy
Intervention Type
Drug
Intervention Name(s)
Leuprorelin
Other Intervention Name(s)
Eligard
Intervention Description
Hormonal therapy
Primary Outcome Measure Information:
Title
Metastases progression-free survival (MPFS)
Description
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
Time Frame
2.5 years after treatment

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jorinde Janssen, MD
Phone
0031503615172
Email
adopt@rt.umcg.nl
First Name & Middle Initial & Last Name or Official Title & Degree
P. Veldhuijzen van Zanten
Phone
0031503614659
Email
adopt@rt.umcg.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
S. Al-Uwini, PhD
Organizational Affiliation
UMCG
Official's Role
Principal Investigator
Facility Information:
Facility Name
Radiotherapy Institute Friesland
City
Leeuwarden
State/Province
Friesland
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
M. de Jong, MD
Facility Name
Radiotherapiegroep
City
Arnhem
State/Province
Gelderland
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
M. A. D. Haverkort, MD
Facility Name
Radboud University Medical Center
City
Nijmegen
State/Province
Gelderland
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
R.J. Smeenk, MD, PhD
Facility Name
Maastro Clinic
City
Maastricht
State/Province
Limburg
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
B. Vanneste, MD, PhD
Facility Name
Catharina Hospital
City
Eindhoven
State/Province
Noord-Brabant
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
T.C.G. Budiharto, MD, PhD
Facility Name
Amsterdam UMC (Location VUmc)
City
Amsterdam
State/Province
Noord-Holland
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
J. van Moorselaar, Professor
Facility Name
Radiotherapiegroep
City
Deventer
State/Province
Overijssel
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
M.A.D. Haverkort, MD
Facility Name
Isala
City
Zwolle
State/Province
Overijssel
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
O. Reerink, MD, PhD
Facility Name
Haga Hospital
City
Den Haag
State/Province
Zuid-Holland
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
B. Hollmann, MD
Facility Name
Leinden University Medical Center
City
Leiden
State/Province
Zuid-Holland
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
S. Rademakers, MD, PhD
Facility Name
Erasmus Medical Center
City
Rotterdam
State/Province
Zuid-Holland
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
K. de Vries, MD
Facility Name
UMCG
City
Groningen
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
J. Janssen, MD
Email
ADOPT@rt.umcg.nl
Facility Name
Verbeeten Institute
City
Tilburg
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
M.A.E. vd Sande, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
35501744
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs