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Prostatic Neoplasms, Castration-ResistantPhase 2OLIGORESISTNCT07717268

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

A Phase 2 study testing Xtandi, Zytiga® (Abiraterone Acetate) and SBRT in people with Prostatic Neoplasms, Castration-Resistant, run by Instituto de Investigación en Oncología Radioterápica - Fundación Española de Oncología Radioterápic at 15 sites in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Any age, men only
What is being tested?
Xtandi, Zytiga® (Abiraterone Acetate) and SBRT
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
51 participants
Where
15 sitesSpain
Study dates
16 May 2024to 16 May 2030
Phase
Phase 2
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 Any age
  • Men only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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 candidate to receive treatment with abiraterone or enzalutamide as per clinical routine, and treatment selection and prescription assigned by responsible physician before the inclusion in the study. or or who has started treatment no more than 14 days prior to signing, as first-line treatment after a diagnosis of oligoresistance.
  • Patients must provide written informed consent.
  • Life expectancy > 3 months.

Who cannot join

  • 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.

Trial locations and contacts

15 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Pablo Raña Diez, PhD contact

+34 696633409

investigacion@seor.es

Cristina Gutierrez Povedano, PhD contact

+34 675039150

cristina.gutierrez.povedano@navarra.es

15 sites in 1 country

Spain15 sites, 6 recruiting

  • Hospital de Cruces

    Barakaldo, Vizcaya, 48903

    Active, not recruiting

  • Hospital Clinic de Barcelona

    Barcelona, Barcelona, 08036

    Joel Mases, MD, mases@clinic.cat

    Joel Mases i Rosinés, MD

    Recruiting

  • Hospital De La Santa Creu I Sant Pau

    Barcelona, Catalonia, 08041

    Gemma Sancho Pardo, MD, +34 935537756, gsancho@santpau.cat

    Saudy Peláez Bonilla, Study coordinator, +34 935537760 ext. 776, SPelaez@santpau.cat

    Recruiting

  • Hospital Universitario Basurto

    Bilbao, Basque Country, 48013

    Active, not recruiting

  • Instituto Catalán de Oncología Hospitalet

    L'Hospitalet de Llobregat, Barcelona, 08908

    Anna Maria Boladeras, MD, aboladeras@iconcologia.net

    Ana María Boladeras Inglada, MD

    Recruiting

  • Hospital Ramón y Cajal

    Madrid, Madrid, 28034

    Active, not recruiting

  • Hospital Clínico San Carlos

    Madrid, Madrid, 28040

    Noelia Sanmamed, MD, +34 985 10 80 00, noelia.sanmamed@salud.madrid.org

    Noelia Sanmamed Salgado, MD

    Recruiting

  • Hospital Universitario Central De Asturias

    Oviedo, Principality of Asturias, 33011

    Active, not recruiting

  • Hospital Universitario de Navarra (HUN)

    Pamplona, Navarre, 31008

    Marta Barrado Los Arcos, MD, +34 848 42 84 82, marta.barrado.losarcos@navarra.es

    Marta Barrado Los Arcos, MD

    Recruiting

  • Hospital Universitario De Salamanca

    Salamanca, Castille and León, 37007

    Active, not recruiting

  • Complexo Hospitalario Universitario De Santiago

    Santiago de Compostela, Galicia, 15706

    Active, not recruiting

  • Consorci Sanitari De Terrassa

    Terrassa, Catalonia, 08227

    Active, not recruiting

  • Hospital Universitario y Politécnico de La Fe

    Valencia, Valencia, 46026

    Active, not recruiting

  • Hospital Clínico Universitario De Valladolid

    Valladolid, Castille and León, 47003

    Patricia Diezhandino Garcia, MD, +34 983 420 003, pdiezhandino@saludcastillayleon.es

    Patricia Diezhandino Garcia, MD

    Recruiting

  • Hospital Universitario Miguel Servet

    Zaragoza, Aragon, 50009

    Active, not recruiting

Other trials in Spain

About this study

Official title: Radioterapia estereotáctica Fraccionada más antiandrógeno de Segunda generación Para Pacientes oligometastásicos Con cáncer de próstata Resistente a la castración. Estudio español Fase II, Prospectivo, multicéntrico.

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).

Read more

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.

Being tested
Xtandi, Zytiga® (Abiraterone Acetate), SBRT
Keywords
Fractionated stereotactic radiotherapy, second-generation antiandrogen, Phase II, castration-resistant prostate cancer, oligometastatic patients
Medical subject headings
Prostatic Neoplasms, Castration-Resistant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • XtandiDrug

    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)

  • Zytiga® (Abiraterone Acetate)Drug

    Also called abiraterone acetate

    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)

  • SBRTRadiation

    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 groups in NCT07717268
Study groupRoleWhat they receive
Second generation antiandrogen plus SBRTOtherEach 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
Receives: Drug: Xtandi; Drug: Zytiga® (Abiraterone Acetate); Radiation: SBRT

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 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)

  1. Overall survival

    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.

    Measured: 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.

  2. Quality of life by EORTC scale

    QoL using the European Organization for Research and Treatment of Cancer (EORTC) quality of life scale, EORTC QLQ-C30, validated for oncology patients.

    The scale converts all scores to a standardized range from 0 (minimum) to 100 (maximum). A high score indicates a better outcome (high quality of life and good health).

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

  3. Acute and chronic toxicity

    Acute and chronic toxicity according to the "Common Terminology Criteria for Adverse Events" (CTCAEv5.0) scale

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2026
  2. Study start16 May 2024
  3. Primary completion16 May 2030 (estimated)
  4. Study completion16 May 2030 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
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
Masking
None (open label)
Enrolment
51 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07717268
Sponsor's protocol ID
IRA-RAD-2022-001
Other IDs
2023-505024-62, 2023
Acronym
OLIGORESIST
Status last verified
Jul 2026
First submitted
13 Jul 2026
Last updated
21 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 28577836

  • 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.

    PubMed 24968866

  • 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.

    PubMed 24135135

  • 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.

    PubMed 25126157

  • 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.

    PubMed 19349616

  • 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.

    PubMed 22608954

  • 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.

    PubMed 26329294

  • 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.

    PubMed 34633602

  • 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.

    PubMed 33730312

  • 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.

    PubMed 20879569

  • 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.

    PubMed 25113765

  • 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.

    PubMed 25349291

  • 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.

    PubMed 7799047

  • 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.

    PubMed 28404761

  • 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.

    PubMed 22997442

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Xtandi, Zytiga® (Abiraterone Acetate) and SBRT in people with Prostatic Neoplasms, Castration-Resistant, run by Instituto de Investigación en Oncología Radioterápica - Fundación Española de Oncología Radioterápic at 15 sites in Spain.

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 7 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Spain. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Contact Pablo Raña Diez, PhD (+34 696633409, investigacion@seor.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determine the PRFS (time frame: 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.). 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 NCT07717268, which also lists 26 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 21 Jul 2026.

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