Fractionated Stereotactic Radiotherapy Plus Second-generation Antiandrogen for Oligometastatic Castration-resistant Prostate Cancer Patients.

NCT07717268 | Recruiting Phase 2

• 2 other identifiers: IRA-RAD-2022-0012023-505024-62
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 15

Brief Summary

The objectives of the study are to analyze the results obtained in survival, safety and quality of life after the combination of SBRT plus second-generation antiandrogen in patients diagnosed with metastatic castration-resistant prostate cancer in oligometastasis (≤5). Hence, the investigators evaluate the results of the combination of two widely used treatments in prostate cancer: SBRT plus the 'standard of care' for patients with mCRPC, second-generation antiandrogens (abiraterone and enzalutamide). Primary objective: Determine the PRFS measured from the time of initiation of second-generation antiandrogen to the time of radiological progression by choline PET/CT or 68Ga-PSMA PET/CT, in patients with mCRPC treated with the combination of second-generation antiandrogen plus SBRT. Secondary objectives:

• Overall survival (time from initiation of second-generation antiandrogen to exitus) in patients with mCRPC treated with the combination of second-generation antiandrogen plus SBRT.
• Quality of life of these patients using the European Organization for Research and Treatment of Cancer (EORTC) quality of life scale, EORTC QLQ-C30, validated for oncology patients.
• Acute and chronic toxicity according to the "Common Terminology Criteria for Adverse Events" (CTCAEv5.0) scale. This is a phase II, multicenter, prospective, single group study in patients with castrate-resistant prostate cancer (CRPC). Patients will be recruited at the participant sites, after study approval and hospital authorization. 51 patients will be included in the study. Eligible patients will require:
• Choline PET/CT or 68Ga-PSMA PET/CT, dated no more than 8 weeks prior to inclusion.
• Clinical history, physical examination and functional evaluation scale (ECOG).
• Geriatric assessment scale for patients \> 75 years (modified G8 scale)
• Toxicity scale assessment (CTCAEv5.0)
• Baseline quality of life questionnaire (EORTC QLQ-C30) (47)
• Blood tests with complete blood count, coagulation, liver function, renal function, ions, alkaline phosphatase, PSA and total and free testosterone, dated no more than 4 weeks prior inclusion.
• Inclusion/exclusion criteria assessment
• Second generation antiandrogen prescription, chosen by the responsible physician according to clinical practice, in each case. Each patient will be included in the study once the second generation antiandrogen is initiated (which will be maintained until radiological progression, suspension due to poor tolerance and/or exitus). SBRT will be performed at least 2 weeks after initiating treatment with second generation antiandrogen, without exceeding 8 weeks from the start of treatment, and follow-up will continue up to a maximum of 36 months after completion of SBRT and/or exitus. Recruitment time is estimated at 36 months and a total follow-up time of 36 months. The total duration of the trial is therefore expected to be 6 years, to allow complete follow-up of the last patients included.

Conditions

Prostatic Neoplasms, Castration-Resistant

Keywords

Fractionated stereotactic radiotherapy; second-generation antiandrogen; Phase II; castration-resistant prostate cancer; oligometastatic patients

Outcome Measures

Primary Outcomes (1)

• Determine the PRFS

  Determine the PRFS measured from the time of initiation of second-generation antiandrogen to the time of radiological progression by choline PET/CT or 68Ga-PSMA PET/CT, in patients with mCRPC treated with the combination of second-generation antiandrogen

  From the start of the study (the day it begins) or up to 14 days before the start of the study (corresponding to the start of treatment with second-generation antiandrogens) until the time of radiological progression during follow-up, it can be up to 36.

Secondary Outcomes (3)

• Overall survival

  From the start of second-generation antiandrogen therapy (at baseline or up to 14 days prior) to the date of death from any cause, assessed up to 36 months.

• Quality of life by EORTC scale

  from recruitment to the end of patient follow-up (up to 36 months)

• Acute and chronic toxicity

  from recruitment to the end of patient follow-up (up to 36 months)

Study Arms (1)

Second generation antiandrogen plus SBRT

OTHER

Each patient will be included in the study once the second generation antiandrogen is initiated (which will be maintained until radiological progression, suspension due to poor tolerance and/or exitus). SBRT will be performed at least 2 weeks after initiating treatment with second generation antiandrogen, without exceeding 8 weeks from the start of treatment, and follow-up will continue up to a maximum of 36 months after completion of SBRT and/or exitus

Drug: Xtandi; Drug: Zytiga® (Abiraterone Acetate); Radiation: SBRT

Interventions

SBRT RADIATION

SBRT will be performed at least 2 weeks after initiating treatment with second generation antiandrogen, without exceeding 8 weeks from the start of treatment, and follow-up will continue up to a maximum of 36 months after completion of SBRT and/or exitus

Second generation antiandrogen plus SBRT

Xtandi DRUG

Each patient will be included in the study once the second generation antiandrogen is initiated (which will be maintained until radiological progression, suspension due to poor tolerance and/or exitus)

Second generation antiandrogen plus SBRT

Zytiga® (Abiraterone Acetate) DRUG

Each patient will be included in the study once the second generation antiandrogen is initiated (which will be maintained until radiological progression, suspension due to poor tolerance and/or exitus)

Also known as: abiraterone acetate

Second generation antiandrogen plus SBRT

Eligibility Criteria

• Gender Eligibility Details: Male gender because the target population is patients with prostate adenocarcinoma
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with histologically prostate adenocarcinoma, confirmed with a biopsy.
• Testosterone in biochemical castration ranges (testosterone \<50 ng/ml or 1.7 nmol/L) and documented progression: biochemical according to Phoenix criteria or distant by radiological confirmation (PSMA PET/CT or Choline PET/CT)
• Biochemistry progression confirmed according to Phoenix criteria, with testosterone in castration levels (testosterone \<50 ng/ml or 1.7 nmol/L).
• Radiological confirmation (with choline-PET/CT or 68Ga-PSMA-PET/CT) of ≤5 node or bone metastasis, non-visceral, eligible to receive SBRT treatment (\< 3 cm major diameter in bone metastases, \< 5 cm in lymph node metastases). In the case of very close metastases, a limit of up to 5 treatment fields with SBRT is allowed, instead of 5 metastases.
• Patients must provide written informed consent.
• Life expectancy \> 3 months.

You may not qualify if:

• Patients with prostate carcinoma with histology other than adenocarcinoma.
• No previous biopsy.
• \> 5 metastasis, not approachables in 5 treatment fields
• Patients with visceral metastasis and or metastasis non elegible to receive SBRT.
• Patients with Testosterone above castration levels
• Patients with prior treatment with docetaxel as first-line CRPC treatment (previous docetaxel treatment is permitted when administered as hormone-sensitive metastatic prostate cancer treatment.

Sponsors & Collaborators

• Fundacion Miguel Servet: collaborator
• Instituto de Investigación en Oncología Radioterápica - Fundación Española de Oncología Radioterápic: lead

Study Sites (15)

Hospital Universitario Miguel Servet

Zaragoza, Aragon, 50009, Spain

ACTIVE NOT RECRUITING

Hospital Clinic de Barcelona

Barcelona, Barcelona, 08036, Spain

RECRUITING

Instituto Catalán de Oncología Hospitalet

L'Hospitalet de Llobregat, Barcelona, 08908, Spain

RECRUITING

Hospital Universitario Basurto

Bilbao, Basque Country, 48013, Spain

ACTIVE NOT RECRUITING

Hospital Universitario De Salamanca

Salamanca, Castille and León, 37007, Spain

ACTIVE NOT RECRUITING

Hospital Clínico Universitario De Valladolid

Valladolid, Castille and León, 47003, Spain

RECRUITING

Hospital De La Santa Creu I Sant Pau

Barcelona, Catalonia, 08041, Spain

RECRUITING

Consorci Sanitari De Terrassa

Terrassa, Catalonia, 08227, Spain

ACTIVE NOT RECRUITING

Complexo Hospitalario Universitario De Santiago

Santiago de Compostela, Galicia, 15706, Spain

ACTIVE NOT RECRUITING

Hospital Ramón y Cajal

Madrid, Madrid, 28034, Spain

ACTIVE NOT RECRUITING

Hospital Clínico San Carlos

Madrid, Madrid, 28040, Spain

RECRUITING

Hospital Universitario de Navarra (HUN)

Pamplona, Navarre, 31008, Spain

RECRUITING

Hospital Universitario Central De Asturias

Oviedo, Principality of Asturias, 33011, Spain

ACTIVE NOT RECRUITING

Hospital Universitario y Politécnico de La Fe

Valencia, Valencia, 46026, Spain

ACTIVE NOT RECRUITING

Hospital de Cruces

Barakaldo, Vizcaya, 48903, Spain

ACTIVE NOT RECRUITING

Related Publications (26)

• Shabason JE, Minn AJ. Radiation and Immune Checkpoint Blockade: From Bench to Clinic. Semin Radiat Oncol. 2017 Jul;27(3):289-298. doi: 10.1016/j.semradonc.2017.03.002. Epub 2017 Mar 16.

  PMID: 28577836 BACKGROUND

• Uppal A, Ferguson MK, Posner MC, Hellman S, Khodarev NN, Weichselbaum RR. Towards a molecular basis of oligometastatic disease: potential role of micro-RNAs. Clin Exp Metastasis. 2014 Aug;31(6):735-48. doi: 10.1007/s10585-014-9664-3. Epub 2014 Jun 27.

  PMID: 24968866 BACKGROUND

• Haffner MC, Mosbruger T, Esopi DM, Fedor H, Heaphy CM, Walker DA, Adejola N, Gurel M, Hicks J, Meeker AK, Halushka MK, Simons JW, Isaacs WB, De Marzo AM, Nelson WG, Yegnasubramanian S. Tracking the clonal origin of lethal prostate cancer. J Clin Invest. 2013 Nov;123(11):4918-22. doi: 10.1172/JCI70354. Epub 2013 Oct 25.

  PMID: 24135135 BACKGROUND

• Reese AS, Feigenberg SJ, Husain A, Webb TJ, Hausner PF, Edelman MJ, Feliciano J, Tkaczuk KH, Sharma NK. Stereotactic Ablative Radiotherapy (SABR): Impact on the Immune System and Potential for Future Therapeutic Modulation. Mol Cell Pharmacol. 2013 Jan 1;5(1):19-25.

  PMID: 25126157 BACKGROUND

• Lee Y, Auh SL, Wang Y, Burnette B, Wang Y, Meng Y, Beckett M, Sharma R, Chin R, Tu T, Weichselbaum RR, Fu YX. Therapeutic effects of ablative radiation on local tumor require CD8+ T cells: changing strategies for cancer treatment. Blood. 2009 Jul 16;114(3):589-95. doi: 10.1182/blood-2009-02-206870. Epub 2009 Apr 6.

  PMID: 19349616 BACKGROUND

• Cox BW, Spratt DE, Lovelock M, Bilsky MH, Lis E, Ryu S, Sheehan J, Gerszten PC, Chang E, Gibbs I, Soltys S, Sahgal A, Deasy J, Flickinger J, Quader M, Mindea S, Yamada Y. International Spine Radiosurgery Consortium consensus guidelines for target volume definition in spinal stereotactic radiosurgery. Int J Radiat Oncol Biol Phys. 2012 Aug 1;83(5):e597-605. doi: 10.1016/j.ijrobp.2012.03.009. Epub 2012 May 19.

  PMID: 22608954 BACKGROUND

• Conde-Moreno AJ, Lopez-Guerra JL, Macias VA, Vazquez de la Torre ML, Samper Ots P, San Jose-Maderuelo S, Pastor Peidro J, Lopez-Torrecilla J, Exposito-Hernandez J. Spanish Society of Radiation Oncology clinical guidelines for stereotactic body radiation therapy in lymph node oligometastases. Clin Transl Oncol. 2016 Apr;18(4):342-51. doi: 10.1007/s12094-015-1383-y. Epub 2015 Sep 2.

  PMID: 26329294 BACKGROUND

• Lopez-Campos F, Cacicedo J, Counago F, Garcia R, Leaman-Alcibar O, Navarro-Martin A, Perez-Montero H, Conde-Moreno A. SEOR SBRT-SG stereotactic body radiation therapy consensus guidelines for non-spine bone metastasis. Clin Transl Oncol. 2022 Feb;24(2):215-226. doi: 10.1007/s12094-021-02695-6. Epub 2021 Oct 11.

  PMID: 34633602 BACKGROUND

• Perez-Calatayud MJ, Conde-Moreno AJ, Celada-Alvarez FJ, Rubio C, Lopez-Campos F, Navarro-Martin A, Arribas L, Santos M, Lopez-Torrecilla J, Perez-Calatayud J. SEOR SBRT-SG survey on SRS/SBRT dose prescription criteria in Spain. Clin Transl Oncol. 2021 Sep;23(9):1794-1800. doi: 10.1007/s12094-021-02583-z. Epub 2021 Mar 17.

  PMID: 33730312 BACKGROUND

• Benedict SH, Yenice KM, Followill D, Galvin JM, Hinson W, Kavanagh B, Keall P, Lovelock M, Meeks S, Papiez L, Purdie T, Sadagopan R, Schell MC, Salter B, Schlesinger DJ, Shiu AS, Solberg T, Song DY, Stieber V, Timmerman R, Tome WA, Verellen D, Wang L, Yin FF. Stereotactic body radiation therapy: the report of AAPM Task Group 101. Med Phys. 2010 Aug;37(8):4078-101. doi: 10.1118/1.3438081.

  PMID: 20879569 BACKGROUND

• Salama JK, Milano MT. Radical irradiation of extracranial oligometastases. J Clin Oncol. 2014 Sep 10;32(26):2902-12. doi: 10.1200/JCO.2014.55.9567. Epub 2014 Aug 11.

  PMID: 25113765 BACKGROUND

• Iyengar P, Kavanagh BD, Wardak Z, Smith I, Ahn C, Gerber DE, Dowell J, Hughes R, Abdulrahman R, Camidge DR, Gaspar LE, Doebele RC, Bunn PA, Choy H, Timmerman R. Phase II trial of stereotactic body radiation therapy combined with erlotinib for patients with limited but progressive metastatic non-small-cell lung cancer. J Clin Oncol. 2014 Dec 1;32(34):3824-30. doi: 10.1200/JCO.2014.56.7412. Epub 2014 Oct 27.

  PMID: 25349291 BACKGROUND

• Hellman S, Weichselbaum RR. Oligometastases. J Clin Oncol. 1995 Jan;13(1):8-10. doi: 10.1200/JCO.1995.13.1.8. No abstract available.

  PMID: 7799047 BACKGROUND

• Ettinger DS, Wood DE, Aisner DL, Akerley W, Bauman J, Chirieac LR, D'Amico TA, DeCamp MM, Dilling TJ, Dobelbower M, Doebele RC, Govindan R, Gubens MA, Hennon M, Horn L, Komaki R, Lackner RP, Lanuti M, Leal TA, Leisch LJ, Lilenbaum R, Lin J, Loo BW Jr, Martins R, Otterson GA, Reckamp K, Riely GJ, Schild SE, Shapiro TA, Stevenson J, Swanson SJ, Tauer K, Yang SC, Gregory K, Hughes M. Non-Small Cell Lung Cancer, Version 5.2017, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2017 Apr;15(4):504-535. doi: 10.6004/jnccn.2017.0050.

  PMID: 28404761 BACKGROUND

• Cardoso F, Harbeck N, Fallowfield L, Kyriakides S, Senkus E; ESMO Guidelines Working Group. Locally recurrent or metastatic breast cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2012 Oct;23 Suppl 7:vii11-9. doi: 10.1093/annonc/mds232. No abstract available.

  PMID: 22997442 BACKGROUND

• Smith M, Parker C, Saad F, Miller K, Tombal B, Ng QS, Boegemann M, Matveev V, Piulats JM, Zucca LE, Karyakin O, Kimura G, Matsubara N, Nahas WC, Nole F, Rosenbaum E, Heidenreich A, Kakehi Y, Zhang A, Krissel H, Teufel M, Shen J, Wagner V, Higano C. Addition of radium-223 to abiraterone acetate and prednisone or prednisolone in patients with castration-resistant prostate cancer and bone metastases (ERA 223): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2019 Mar;20(3):408-419. doi: 10.1016/S1470-2045(18)30860-X. Epub 2019 Feb 6.

  PMID: 30738780 BACKGROUND

• Morris MJ, Heller G, Hillman DW, Bobek O, Ryan C, Antonarakis ES, Bryce AH, Hahn O, Beltran H, Armstrong AJ, Schwartz L, Lewis LD, Beumer JH, Langevin B, McGary EC, Mehan PT, Goldkorn A, Roth BJ, Xiao H, Watt C, Taplin ME, Halabi S, Small EJ. Randomized Phase III Study of Enzalutamide Compared With Enzalutamide Plus Abiraterone for Metastatic Castration-Resistant Prostate Cancer (Alliance A031201 Trial). J Clin Oncol. 2023 Jun 20;41(18):3352-3362. doi: 10.1200/JCO.22.02394. Epub 2023 Mar 30.

  PMID: 36996380 BACKGROUND

• Beer TM, Armstrong AJ, Rathkopf D, Loriot Y, Sternberg CN, Higano CS, Iversen P, Evans CP, Kim CS, Kimura G, Miller K, Saad F, Bjartell AS, Borre M, Mulders P, Tammela TL, Parli T, Sari S, van Os S, Theeuwes A, Tombal B. Enzalutamide in Men with Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer: Extended Analysis of the Phase 3 PREVAIL Study. Eur Urol. 2017 Feb;71(2):151-154. doi: 10.1016/j.eururo.2016.07.032. Epub 2016 Jul 28.

  PMID: 27477525 BACKGROUND

• Armstrong AJ, Lin P, Tombal B, Saad F, Higano CS, Joshua AM, Parli T, Rosbrook B, van Os S, Beer TM. Five-year Survival Prediction and Safety Outcomes with Enzalutamide in Men with Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer from the PREVAIL Trial. Eur Urol. 2020 Sep;78(3):347-357. doi: 10.1016/j.eururo.2020.04.061. Epub 2020 Jun 9.

  PMID: 32527692 BACKGROUND

• Rathkopf DE, Smith MR, de Bono JS, Logothetis CJ, Shore ND, de Souza P, Fizazi K, Mulders PF, Mainwaring P, Hainsworth JD, Beer TM, North S, Fradet Y, Van Poppel H, Carles J, Flaig TW, Efstathiou E, Yu EY, Higano CS, Taplin ME, Griffin TW, Todd MB, Yu MK, Park YC, Kheoh T, Small EJ, Scher HI, Molina A, Ryan CJ, Saad F. Updated interim efficacy analysis and long-term safety of abiraterone acetate in metastatic castration-resistant prostate cancer patients without prior chemotherapy (COU-AA-302). Eur Urol. 2014 Nov;66(5):815-25. doi: 10.1016/j.eururo.2014.02.056. Epub 2014 Mar 6.

  PMID: 24647231 BACKGROUND

• Ryan CJ, Smith MR, Fizazi K, Saad F, Mulders PF, Sternberg CN, Miller K, Logothetis CJ, Shore ND, Small EJ, Carles J, Flaig TW, Taplin ME, Higano CS, de Souza P, de Bono JS, Griffin TW, De Porre P, Yu MK, Park YC, Li J, Kheoh T, Naini V, Molina A, Rathkopf DE; COU-AA-302 Investigators. Abiraterone acetate plus prednisone versus placebo plus prednisone in chemotherapy-naive men with metastatic castration-resistant prostate cancer (COU-AA-302): final overall survival analysis of a randomised, double-blind, placebo-controlled phase 3 study. Lancet Oncol. 2015 Feb;16(2):152-60. doi: 10.1016/S1470-2045(14)71205-7. Epub 2015 Jan 16.

  PMID: 25601341 BACKGROUND

• Beer TM, Armstrong AJ, Rathkopf DE, Loriot Y, Sternberg CN, Higano CS, Iversen P, Bhattacharya S, Carles J, Chowdhury S, Davis ID, de Bono JS, Evans CP, Fizazi K, Joshua AM, Kim CS, Kimura G, Mainwaring P, Mansbach H, Miller K, Noonberg SB, Perabo F, Phung D, Saad F, Scher HI, Taplin ME, Venner PM, Tombal B; PREVAIL Investigators. Enzalutamide in metastatic prostate cancer before chemotherapy. N Engl J Med. 2014 Jul 31;371(5):424-33. doi: 10.1056/NEJMoa1405095. Epub 2014 Jun 1.

  PMID: 24881730 BACKGROUND

• Ryan CJ, Smith MR, de Bono JS, Molina A, Logothetis CJ, de Souza P, Fizazi K, Mainwaring P, Piulats JM, Ng S, Carles J, Mulders PF, Basch E, Small EJ, Saad F, Schrijvers D, Van Poppel H, Mukherjee SD, Suttmann H, Gerritsen WR, Flaig TW, George DJ, Yu EY, Efstathiou E, Pantuck A, Winquist E, Higano CS, Taplin ME, Park Y, Kheoh T, Griffin T, Scher HI, Rathkopf DE; COU-AA-302 Investigators. Abiraterone in metastatic prostate cancer without previous chemotherapy. N Engl J Med. 2013 Jan 10;368(2):138-48. doi: 10.1056/NEJMoa1209096. Epub 2012 Dec 10.

  PMID: 23228172 BACKGROUND

• Scher HI, Fizazi K, Saad F, Taplin ME, Sternberg CN, Miller K, de Wit R, Mulders P, Chi KN, Shore ND, Armstrong AJ, Flaig TW, Flechon A, Mainwaring P, Fleming M, Hainsworth JD, Hirmand M, Selby B, Seely L, de Bono JS; AFFIRM Investigators. Increased survival with enzalutamide in prostate cancer after chemotherapy. N Engl J Med. 2012 Sep 27;367(13):1187-97. doi: 10.1056/NEJMoa1207506. Epub 2012 Aug 15.

  PMID: 22894553 BACKGROUND

• de Bono JS, Logothetis CJ, Molina A, Fizazi K, North S, Chu L, Chi KN, Jones RJ, Goodman OB Jr, Saad F, Staffurth JN, Mainwaring P, Harland S, Flaig TW, Hutson TE, Cheng T, Patterson H, Hainsworth JD, Ryan CJ, Sternberg CN, Ellard SL, Flechon A, Saleh M, Scholz M, Efstathiou E, Zivi A, Bianchini D, Loriot Y, Chieffo N, Kheoh T, Haqq CM, Scher HI; COU-AA-301 Investigators. Abiraterone and increased survival in metastatic prostate cancer. N Engl J Med. 2011 May 26;364(21):1995-2005. doi: 10.1056/NEJMoa1014618.

  PMID: 21612468 BACKGROUND

• Kirby M, Hirst C, Crawford ED. Characterising the castration-resistant prostate cancer population: a systematic review. Int J Clin Pract. 2011 Nov;65(11):1180-92. doi: 10.1111/j.1742-1241.2011.02799.x.

  PMID: 21995694 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms, Castration-Resistant

Interventions

enzalutamide; Abiraterone Acetate

Condition Hierarchy (Ancestors)

Prostatic Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Marta Barrado Los Arcos, MD

  Hospital of Navarra

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pablo Raña Diez, PhD

CONTACT

+34 696633409; investigacion@seor.es

Cristina Gutierrez Povedano, PhD

CONTACT

+34 675039150; cristina.gutierrez.povedano@navarra.es

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each patient will be included in the study once the second generation antiandrogen is initiated (which will be maintained until radiological progression, suspension due to poor tolerance and/or exitus). SBRT will be performed at least 2 weeks after initiating treatment with second generation antiandrogen, without exceeding 8 weeks from the start of treatment, and follow-up will continue up to a maximum of 36 months after completion of SBRT and/or exitus

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 21, 2026
• Study Start: May 16, 2024
• Primary Completion (Estimated): May 16, 2030
• Study Completion (Estimated): May 16, 2030
• Last Updated: July 21, 2026

Record last verified: 2026-07

Locations

ES (15)