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| Name | Class |
|---|---|
| Dutch Cancer Society | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiotherapy without hormonal therapy | Active Comparator | Metastase-directed radiotherapy without the addition of hormonal therapy |
|
| Radiotherapy combined with hormonal therapy | Experimental | Metastase-directed radiotherapy with the addition of of short-term hormonal therapy (6 months) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiotherapy | Radiation | Radiotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 2.5 years after treatment |
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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.
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
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| Name | Affiliation | Role |
|---|---|---|
| S. Al-Uwini, PhD | University Medical Center Groningen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radiotherapiegroep | Arnhem | Gelderland | Netherlands | |||
| Radboud University Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41698328 | Derived | 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. | |
| 38421252 |
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Multicentre, randomized study. A total of 280 patients will participate in this study, equally divided between both study groups
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| Leuprorelin | Drug | Hormonal therapy |
|
|
| Nijmegen |
| Gelderland |
| Netherlands |
| Maastro Clinic | Maastricht | Limburg | Netherlands |
| Catharina Hospital | Eindhoven | North Brabant | Netherlands |
| Amsterdam UMC (Location VUmc) | Amsterdam | North Holland | Netherlands |
| Radiotherapiegroep | Deventer | Overijssel | Netherlands |
| Isala | Zwolle | Overijssel | Netherlands |
| Radiotherapy Institute Friesland | Leeuwarden | Provincie Friesland | Netherlands |
| Leinden University Medical Center | Leiden | South Holland | Netherlands |
| Erasmus Medical Center | Rotterdam | South Holland | Netherlands |
| Haga Hospital | The Hague | South Holland | Netherlands |
| UMCG | Groningen | Netherlands |
| Verbeeten Institute | Tilburg | Netherlands |
| Derived |
| Morgan 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. |
| 35501744 | Derived | 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. |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D016634 | Radiosurgery |
| D016729 | Leuprolide |
| C493311 | luprolide acetate gel depot |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
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