Clinical trial · Interventional
Androgen Deprivation Therapy for Oligo-recurrent Prostate Cancer in Addition to radioTherapy
NCT04302454CI-TRIAL-00088134ADOPTactive not recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Leuprorelin | Drug | Leuprolide | ALIAS |
| Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Radiotherapy without hormonal therapy
- description
- Metastase-directed radiotherapy without the addition of hormonal therapy
- interventionNames
- Radiation: Radiotherapy
- type
- EXPERIMENTAL
- label
- Radiotherapy combined with hormonal therapy
- description
- Metastase-directed radiotherapy with the addition of of short-term hormonal therapy (6 months)
- interventionNames
- Radiation: Radiotherapy
- Drug: Leuprorelin
Primary outcomes (1)
- measure
- Metastases progression-free survival (MPFS)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (3)
- DERIVEDNikitas 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. PMID 41698328
- DERIVEDMorgan 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. PMID 38421252
- DERIVEDJanssen 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. PMID 35501744