Prostate CancerPhase 3ADOPTNCT04302454
Androgen Deprivation Therapy for Oligo-recurrent Prostate Cancer in Addition to radioTherapy
A Phase 3 study testing Radiotherapy and Leuprorelin in people with Prostate Cancer, run by University Medical Center Groningen at 13 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Radiotherapy and Leuprorelin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 13 sitesNetherlands
- Study dates
- 19 Mar 2020to 1 Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 13Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Netherlands13 sites
Amsterdam UMC (Location VUmc)
Amsterdam, North Holland
Radiotherapiegroep
Arnhem, Gelderland
Radiotherapiegroep
Deventer, Overijssel
Catharina Hospital
Eindhoven, North Brabant
UMCG
Groningen
Radiotherapy Institute Friesland
Leeuwarden, Provincie Friesland
Leinden University Medical Center
Leiden, South Holland
Maastro Clinic
Maastricht, Limburg
Radboud University Medical Center
Nijmegen, Gelderland
Erasmus Medical Center
Rotterdam, South Holland
Haga Hospital
The Hague, South Holland
Verbeeten Institute
Tilburg
Isala
Zwolle, Overijssel
About this study
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.
- Conditions
- Prostate Cancer
- Being tested
- Radiotherapy, Leuprorelin
- Keywords
- Prostate cancer, Oligometastasis, Stereotactic Body Radiation Therapy, Androgen Deprivation Therapy, Biochemical recurrence, PSMA PET/CT, Metastases-directed radiotherapy, Metastases progression-free survival
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiotherapyRadiation
Also called MDRT, Metastase-directed radiotherapy, SBRT, Stereotactic body radiotherapy
Radiotherapy
LeuprorelinDrug
Also called Eligard
Hormonal therapy
| Study group | Role | What they receive |
|---|---|---|
| Radiotherapy without hormonal therapy | Active comparator | Metastase-directed radiotherapy without the addition of hormonal therapy Receives: Radiation: Radiotherapy |
| Radiotherapy combined with hormonal therapy | Experimental | Metastase-directed radiotherapy with the addition of of short-term hormonal therapy (6 months) Receives: Radiation: Radiotherapy; Drug: Leuprorelin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2.5 years after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2020
- Study start19 Mar 2020
- Primary completion21 Oct 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Cancer Society
- Responsible party
- Sponsor
- Investigators
- S. Al-Uwini, PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04302454
- Sponsor's protocol ID
- RT2019-13
- Acronym
- ADOPT
- Status last verified
- Apr 2025
- First submitted
- 6 Mar 2020
- Last updated
- 4 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nikitas J, Smith CP, Armstrong WR, Murthy V, Grogan T, Clark K, Moore J, Roberts M, Farolfi A, Reiter RE, Rettig MB, Shen J, Valle LF, Nickols NG, Steinberg ML, Czernin J, Kishan AU, Calais J. Five-Year Outcomes After Prostate-Specific Membrane Antigen PET/CT-Guided Salvage Radiotherapy Following Radical Prostatectomy. J Natl Compr Canc Netw. 2026 Feb;24(2):11-18. doi: 10.6004/jnccn.2025.7102.
PubMed 41698328Morgan TM, Boorjian SA, Buyyounouski MK, Chapin BF, Chen DYT, Cheng HH, Chou R, Jacene HA, Kamran SC, Kim SK, Kirkby E, Luckenbaugh AN, Nathanson BJ, Nyame YA, Posadas EM, Tran PT, Chen RC. Salvage Therapy for Prostate Cancer: AUA/ASTRO/SUO Guideline Part III: Salvage Therapy After Radiotherapy or Focal Therapy, Pelvic Nodal Recurrence and Oligometastasis, and Future Directions. J Urol. 2024 Apr;211(4):526-532. doi: 10.1097/JU.0000000000003890. Epub 2024 Feb 29.
PubMed 38421252Janssen 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.
PubMed 35501744
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Androgen Deprivation Therapy for Oligo-recurrent Prostate Cancer in Addition to radioTherapy
- ClinicalTrials.gov ID
- NCT04302454
- Acronym / sponsor ID
- ADOPT / RT2019-13
- 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
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- Dutch Cancer Society
- Study start
- 19 Mar 2020 (actual)
- Primary completion
- 21 Oct 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 10 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multicentre, randomized study. A total of 280 patients will participate in this study, equally divided between both study groups
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy without hormonal therapy | Active comparator | Radiation: RadiotherapyMetastase-directed radiotherapy without the addition of hormonal therapy |
| Radiotherapy combined with hormonal therapy | Experimental | Radiation: Radiotherapy, Drug: LeuprorelinMetastase-directed radiotherapy with the addition of of short-term hormonal therapy (6 months) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
- Age > 18 years.
- Recent PSMA-PET/CT scan within 60 days prior to randomization.
Key exclusion criteria (8 listed)
- Visceral metastases.
- PSA ≥ 10 ng/ml.
- PSA-doubling time ≤ 3 months.
- ADT or chemotherapy for recurrent PCa.
- Testosterone < 1.7 nmol/l
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RadiotherapyAlso: MDRT, Metastase-directed radiotherapy, SBRT, Stereotactic body radiotherapyRadiotherapy | Radiation | Radiotherapy combined with hormonal therapy, Radiotherapy without hormonal therapy |
| LeuprorelinAlso: EligardHormonal therapy | Drug | Radiotherapy combined with hormonal therapy |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Derived from this study: PubMed 41698328Nikitas J, Smith CP, Armstrong WR, Murthy V, Grogan T, Clark K, Moore J, Roberts M, Farolfi A, Reiter RE, Rettig MB, Shen J, Valle LF, Nickols NG, Steinberg ML, Czernin J, Kishan AU, Calais J. Five-Year Outcomes After Prostate-Specific Membrane Antigen PET/CT-Guided Salvage Radiotherapy Following Radical Prostatectomy. J Natl Compr Canc Netw. 2026 Feb;24(2):11-18. doi: 10.6004/jnccn.2025.7102.
- Derived from this study: PubMed 38421252Morgan TM, Boorjian SA, Buyyounouski MK, Chapin BF, Chen DYT, Cheng HH, Chou R, Jacene HA, Kamran SC, Kim SK, Kirkby E, Luckenbaugh AN, Nathanson BJ, Nyame YA, Posadas EM, Tran PT, Chen RC. Salvage Therapy for Prostate Cancer: AUA/ASTRO/SUO Guideline Part III: Salvage Therapy After Radiotherapy or Focal Therapy, Pelvic Nodal Recurrence and Oligometastasis, and Future Directions. J Urol. 2024 Apr;211(4):526-532. doi: 10.1097/JU.0000000000003890. Epub 2024 Feb 29.
- Derived from this study: PubMed 35501744Janssen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
S. Al-Uwini, PhD principal investigator
University Medical Center Groningen
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Radiotherapy and Leuprorelin in people with Prostate Cancer, run by University Medical Center Groningen at 13 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metastases progression-free survival (MPFS) (time frame: 2.5 years after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04302454, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.