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AzTrials

Prostate CancerPhase 3Apa/Enza-shortNCT07260435

Apa/Enza-short Study: Shorter Treatment With Androgen Receptor Pathway Inhibitor in Patients With Low-volume Metastatic Castration-sensitive Prostate Cancer

A Phase 3 study testing ADT plus only 12 months of ARPI and ADT plus continued ARPI in people with Prostate Cancer, run by Nick Beije at 26 sites in Netherlands.

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 goal of this clinical trial is to evaluate the outcomes of a shorter treatment duration (12 months) with an androgen receptor pathway inhibitor (ARPI), in this study Apalutamide or Enzalutamide, in patients with low-volume, hormone-sensitive metastatic prostate cancer (mCSPC), with the possibility to restart… 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?
ADT plus only 12 months of ARPI and ADT plus continued ARPI
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
26 sitesNetherlands
Study dates
20 Feb 2024to 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

  • Male and ≥18 years of age
  • Capable of understanding and complying with protocol requirements and able to understand and sign the informed consent form
  • Histological diagnosis of prostate adenocarcinoma
  • Low volume de novo metastatic disease (M1a or M1b) defined as anything other than fitting the criteria for high-volume metastatic disease, e.g., four or more bone lesions with one or more lesions in any body structure beyond the spine or pelvis, or visceral disease (non-nodal). This has been assessed by either bone scan and computed tomography (CT), or PSMA-PET scan. Low-volume disease has subsequently been confirmed by the local (multidisciplinary) team after consideration of the available imaging results as per the standard imaging protocol for the site.
  • ADT initiated within 6 weeks prior to inclusion
  • Eastern Cooperative Oncology Group (ECOG) performance scale status of 0, 1 or 2
  • Fit for treatment with apalutamide or enzalutamide according to treating physician

Who cannot join

  • Pathological finding consistent with small cell, ductal or neuroendocrine carcinoma of the prostate
  • Other prior malignancy less than or equal to 5 years prior to randomization except for squamous or basal cell skin carcinoma or non-invasive superficial bladder cancer
  • History of seizures or medications known to lower seizure threshold
  • Any other prior treatment for prostate cancer other than ADT (e.g., other next generation anti-androgens or other CYP17 inhibitors, chemotherapy, immunotherapy, or radiopharmaceutical agents)
  • ADT started more than 6 weeks before inclusion

Trial locations and contacts

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

Dr. N. Beije contact

+31010 704 0704

n.beije@erasmusmc.nl

26 sites in 1 country

Netherlands26 sites, 26 recruiting

  • Noordwest Ziekenhuisgroep

    Alkmaar

    Dr. M. Hendriks, +31072 548 4444, M.P.Hendriks@nwz.nl

    Recruiting

  • Meander MC Amersfoort

    Amersfoort

    Dr. J.M. van Dodewaard-de Jong, +31033 - 850 5050, JM.van.Dodewaard@meandermc.nl

    Not yet recruiting

  • Amsterdam Universitair Medisch Centrum

    Amsterdam

    Prof. dr. A.J.M. van den Eertwegh, +31(020) 566 9111, vandeneertwegh@amsterdamumc.nl

    Not yet recruiting

  • Antoni van Leeuwenhoek

    Amsterdam

    dr. Koen van der Mijn, +31020 512 9111, k.vd.mijn@nki.nl

    Not yet recruiting

  • Wilhelmina Ziekenhuis Assen

    Assen

    Dr. P. Nieboer, +310592 325 555, peter.nieboer@wza.nl

    Recruiting

  • Rode Kruis Ziekenhuis

    Beverwijk

    Dr. Goosens, +310251 265 555, agoosens@rkz.nl

    Recruiting

  • Deventer Ziekenhuis

    Deventer

    Dr. A. Imholz, +31 0570 53 53 53, A.Imholz@dz.nl

    Recruiting

  • Catharina Ziekenhuis

    Eindhoven

    Dr. L.J.C. van Warmerdam, +31040 239 9111, laurence.v.warmerdam@catharinaziekenhuis.nl

    Recruiting

  • Treant Zorggroep

    Emmen

    Dr. M.Pijffers, +31088 129 2929, m.tent@treant.nl

    Recruiting

  • Medisch Spectrum Twente

    Enschede

    Dr. A.N.M. Wymenga, +31(053) 487 20 00, A.Wymenga@mst.nl

    Recruiting

  • Admiraal de Ruyter ziekenhuis

    Goes

    Dr. K.W.J. Hoeben, +31088 125 00 00, k.hoeben@adrz.nl

    Recruiting

  • Universitair Medisch Centrum Groningen

    Groningen

    Dr. M. van Kruchten, +31050 361 6161, m.van.kruchten@umcg.nl

    Recruiting

  • Spaarne Gasthuis

    Haarlem

    Dr. A. Beeker, +31023 224 0000, ABeeker@spaarnegasthuis.nl

    Recruiting

  • Ziekenhuisgroep Twente

    Hengelo

    Dr. L. Oving, +31088 708 7878, I.Oving@zgt.nl

    Recruiting

  • Tergooi MC

    Hilversum

    dr. P van den Berg, +31088 753 1753, pvandenberg@tergooi.nl

    Not yet recruiting

  • Frisius MC Leeuwarden

    Leeuwarden

    Dr. B. Rikhof, +31(058) 286 66 66, Bart.Rikhof@mcl.nl

    Recruiting

  • Maastricht UMC

    Maastricht

    Dr. T.M.A. Kerkhofs, +31043 387 6543, thomas.kerkhofs@mumc.nl

    Recruiting

  • Canisius Wilhelmina Ziekenhuis

    Nijmegen

    Dr. D.M. Somford, +31 024 365 76 57, r.somford@cwz.nl

    Recruiting

  • Laurentius Ziekenhuis

    Roermond

    Dr. L. Verhoeven, +310475 382 222, loes.verhoeven@lzr.nl

    Recruiting

  • Bravis Ziekenhuis

    Roosendaal

    Dr. S. Boudewijns, +310887068000, s.boudewijns@bravis.nl

    Recruiting

  • Erasmus mc

    Rotterdam

    Nick Beije, DR, +31107041906, interne.oncologie@erasmusmc.nl

    Beije, interne.oncologie@erasmusmc.nl

    Recruiting

  • Fransicus Gasthuis & Vlietland

    Rotterdam

    Dr. P. Hamberg, +31010 - 461 6161, p.hamberg@franciscus.nl

    Recruiting

  • Maasstad Ziekenhuis

    Rotterdam

    Dr. B.C.M. Haberkorn, +31(010) 291 19 11, HaberkornB@maasstadziekenhuis.nl

    Recruiting

  • HagaZiekenhuis

    The Hague

    Dr. D. Houtsma, +31070 210 0000, d.houtsma@hagaziekenhuis.nl

    Recruiting

  • St. Antonius Ziekenhuis

    Utrecht

    dr. J. Hunting, +31088 320 3000, j.hunting@antoniusziekenhuis.nl

    Not yet recruiting

  • VieCuri Medisch Centrum

    Venlo

    Dr. P. Rutten-Werner, +31077 320 5555, pwerner@viecuri.nl

    Recruiting

Other trials in Netherlands

About this study

Official title: Apa/Enza Short Study: Shortened 12 Months Duration of Androgen Receptor Signaling Agent in Combination With Androgen Deprivation Therapy in Patients With Low Volume Castration-sensitive Prostate Cancer: a Randomized Nationwide Study

The goal of this clinical trial is to evaluate the outcomes of a shorter treatment duration (12 months) with an androgen receptor pathway inhibitor (ARPI), in this study Apalutamide or Enzalutamide, in patients with low-volume, hormone-sensitive metastatic prostate cancer (mCSPC), with the possibility to restart treatment if needed.

The main research question is whether discontinuation of ARPI therapy after 12 months, with the option to restart treatment upon disease progression, is non-inferior to continued ARPI therapy, potentially reducing toxicity and costs.

Read more

Eligible patients will be randomized after completing 12 months of ARPI treatment, to one of the following two arms:

  1. ADT + continued ARPI (Apalutamide or Enzalutamide)
  2. ADT + ARPI discontinued after 12 months, with the option to resume ARPI in case of a confirmed PSA rise. The confirmatory PSA sample must be obtained at least 4 weeks after the initial rise.

This study aims to minimize toxicity associated with prolonged use of ARPIs in patients with low-volume, hormone-sensitive metastatic prostate cancer.

Conditions
Prostate Cancer
Being tested
ADT plus only 12 months of ARPI, ADT plus continued ARPI
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • ADT plus only 12 months of ARPIDrug

    ADT plus only 12 months of ARPI (apalutamide/enzalutamide) with the possibility to resume treatment with ARSI in case of a confirmed PSA rise.

  • ADT plus continued ARPIDrug

    ADT plus continued ARPI (apalutamide/enzalutamide) to the moment of progression

Study groups in NCT07260435
Study groupRoleWhat they receive
ADT plus continued ARPI (apalutamide/enzalutamide)ExperimentalNot described
Receives: Drug: ADT plus continued ARPI
ADT plus only 12 months of ARPI (apalutamide/enzalutamide) with the possibility tExperimentalNot described
Receives: Drug: ADT plus only 12 months of ARPI

What is being measured

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

  1. Time to clinical progression free survival (cPFS) in both arms.

    To prospectively evaluate whether shortened (12 months) treatment with ARPIs, with retreatment with ARPIs in case of PSA progression (defined according to PSA progression criteria) is non-inferior with respect to clinical progression free survival (boundary of max -10% at 48 months) to continued treatment with ARPI evaluated by comparing time to cPFS (as defined in primary endpoint) in both arms.

    Measured: From inclusion to the last day of treatment or moment of progression (whichever occurs first). Subjects will participate for 5 years, after randomization. In total, patients will participate for 6 years.

Timeline

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

  1. First posted3 Dec 2025
  2. Study start20 Feb 2024
  3. Primary completion30 Nov 2027 (estimated)
  4. Study completionDec 2027 (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 3
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07260435
Sponsor's protocol ID
EU CT 2023-506698-36
Acronym
Apa/Enza-short
Status last verified
Dec 2025
First submitted
21 Nov 2025
Last updated
3 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Ian, D.D., et al., Updated overall survival outcomes in ENZAMET (ANZUP 1304), an international, cooperative group trial of enzalutamide in metastatic hormone-sensitive prostate cancer (mHSPC). Journal of Clinical Oncology, 2022. 40(17_suppl): p. LBA5004-LBA5004.

  • Belic J, Koch M, Ulz P, Auer M, Gerhalter T, Mohan S, Fischereder K, Petru E, Bauernhofer T, Geigl JB, Speicher MR, Heitzer E. Rapid Identification of Plasma DNA Samples with Increased ctDNA Levels by a Modified FAST-SeqS Approach. Clin Chem. 2015 Jun;61(6):838-49. doi: 10.1373/clinchem.2014.234286. Epub 2015 Apr 20.

    PubMed 25896989

  • Angus L, Deger T, Jager A, Martens JWM, de Weerd V, van Heuvel I, van den Bent MJ, Sillevis Smitt PAE, Kros JM, Bindels EMJ, Heitzer E, Sleijfer S, Jongen JLM, Wilting SM. Detection of Aneuploidy in Cerebrospinal Fluid from Patients with Breast Cancer Can Improve Diagnosis of Leptomeningeal Metastases. Clin Cancer Res. 2021 May 15;27(10):2798-2806. doi: 10.1158/1078-0432.CCR-20-3954. Epub 2021 Jan 29.

    PubMed 33514525

  • Mendelaar PAJ, Robbrecht DGJ, Rijnders M, de Wit R, de Weerd V, Deger T, Westgeest HM, Aarts MJB, Voortman J, Martens JWM, van der Veldt AAM, Nakauma-Gonzalez JA, Wilting SM, Lolkema M. Genome-wide aneuploidy detected by mFast-SeqS in circulating cell-free DNA is associated with poor response to pembrolizumab in patients with advanced urothelial cancer. Mol Oncol. 2022 May;16(10):2086-2097. doi: 10.1002/1878-0261.13196. Epub 2022 Mar 17.

    PubMed 35181986

  • Bettegowda C, Sausen M, Leary RJ, Kinde I, Wang Y, Agrawal N, Bartlett BR, Wang H, Luber B, Alani RM, Antonarakis ES, Azad NS, Bardelli A, Brem H, Cameron JL, Lee CC, Fecher LA, Gallia GL, Gibbs P, Le D, Giuntoli RL, Goggins M, Hogarty MD, Holdhoff M, Hong SM, Jiao Y, Juhl HH, Kim JJ, Siravegna G, Laheru DA, Lauricella C, Lim M, Lipson EJ, Marie SK, Netto GJ, Oliner KS, Olivi A, Olsson L, Riggins GJ, Sartore-Bianchi A, Schmidt K, Shih lM, Oba-Shinjo SM, Siena S, Theodorescu D, Tie J, Harkins TT, Veronese S, Wang TL, Weingart JD, Wolfgang CL, Wood LD, Xing D, Hruban RH, Wu J, Allen PJ, Schmidt CM, Choti MA, Velculescu VE, Kinzler KW, Vogelstein B, Papadopoulos N, Diaz LA Jr. Detection of circulating tumor DNA in early- and late-stage human malignancies. Sci Transl Med. 2014 Feb 19;6(224):224ra24. doi: 10.1126/scitranslmed.3007094.

    PubMed 24553385

  • Vandekerkhove G, Struss WJ, Annala M, Kallio HML, Khalaf D, Warner EW, Herberts C, Ritch E, Beja K, Loktionova Y, Hurtado-Coll A, Fazli L, So A, Black PC, Nykter M, Tammela T, Chi KN, Gleave ME, Wyatt AW. Circulating Tumor DNA Abundance and Potential Utility in De Novo Metastatic Prostate Cancer. Eur Urol. 2019 Apr;75(4):667-675. doi: 10.1016/j.eururo.2018.12.042. Epub 2019 Jan 10.

    PubMed 30638634

  • Evans CP, Higano CS, Keane T, Andriole G, Saad F, Iversen P, Miller K, Kim CS, Kimura G, Armstrong AJ, Sternberg CN, Loriot Y, de Bono J, Noonberg SB, Mansbach H, Bhattacharya S, Perabo F, Beer TM, Tombal B. The PREVAIL Study: Primary Outcomes by Site and Extent of Baseline Disease for Enzalutamide-treated Men with Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer. Eur Urol. 2016 Oct;70(4):675-683. doi: 10.1016/j.eururo.2016.03.017. Epub 2016 Mar 19.

    PubMed 27006332

  • Nadal R, Taplin ME, Bellmunt J. Enzalutamide for the treatment of prostate cancer: results and implications of the AFFIRM trial. Future Oncol. 2014 Feb;10(3):351-62. doi: 10.2217/fon.13.275.

    PubMed 24559444

  • Sternberg CN, Fizazi K, Saad F, Shore ND, De Giorgi U, Penson DF, Ferreira U, Efstathiou E, Madziarska K, Kolinsky MP, Cubero DIG, Noerby B, Zohren F, Lin X, Modelska K, Sugg J, Steinberg J, Hussain M; PROSPER Investigators. Enzalutamide and Survival in Nonmetastatic, Castration-Resistant Prostate Cancer. N Engl J Med. 2020 Jun 4;382(23):2197-2206. doi: 10.1056/NEJMoa2003892. Epub 2020 May 29.

    PubMed 32469184

  • Smith MR, Saad F, Chowdhury S, Oudard S, Hadaschik BA, Graff JN, Olmos D, Mainwaring PN, Lee JY, Uemura H, Lopez-Gitlitz A, Trudel GC, Espina BM, Shu Y, Park YC, Rackoff WR, Yu MK, Small EJ; SPARTAN Investigators. Apalutamide Treatment and Metastasis-free Survival in Prostate Cancer. N Engl J Med. 2018 Apr 12;378(15):1408-1418. doi: 10.1056/NEJMoa1715546. Epub 2018 Feb 8.

    PubMed 29420164

  • Hussain M, Tangen CM, Berry DL, Higano CS, Crawford ED, Liu G, Wilding G, Prescott S, Kanaga Sundaram S, Small EJ, Dawson NA, Donnelly BJ, Venner PM, Vaishampayan UN, Schellhammer PF, Quinn DI, Raghavan D, Ely B, Moinpour CM, Vogelzang NJ, Thompson IM Jr. Intermittent versus continuous androgen deprivation in prostate cancer. N Engl J Med. 2013 Apr 4;368(14):1314-25. doi: 10.1056/NEJMoa1212299.

    PubMed 23550669

  • Zhang J, Cunningham JJ, Brown JS, Gatenby RA. Integrating evolutionary dynamics into treatment of metastatic castrate-resistant prostate cancer. Nat Commun. 2017 Nov 28;8(1):1816. doi: 10.1038/s41467-017-01968-5.

    PubMed 29180633

  • James ND, de Bono JS, Spears MR, Clarke NW, Mason MD, Dearnaley DP, Ritchie AWS, Amos CL, Gilson C, Jones RJ, Matheson D, Millman R, Attard G, Chowdhury S, Cross WR, Gillessen S, Parker CC, Russell JM, Berthold DR, Brawley C, Adab F, Aung S, Birtle AJ, Bowen J, Brock S, Chakraborti P, Ferguson C, Gale J, Gray E, Hingorani M, Hoskin PJ, Lester JF, Malik ZI, McKinna F, McPhail N, Money-Kyrle J, O'Sullivan J, Parikh O, Protheroe A, Robinson A, Srihari NN, Thomas C, Wagstaff J, Wylie J, Zarkar A, Parmar MKB, Sydes MR; STAMPEDE Investigators. Abiraterone for Prostate Cancer Not Previously Treated with Hormone Therapy. N Engl J Med. 2017 Jul 27;377(4):338-351. doi: 10.1056/NEJMoa1702900. Epub 2017 Jun 3.

    PubMed 28578639

  • Chi KN, Agarwal N, Bjartell A, Chung BH, Pereira de Santana Gomes AJ, Given R, Juarez Soto A, Merseburger AS, Ozguroglu M, Uemura H, Ye D, Deprince K, Naini V, Li J, Cheng S, Yu MK, Zhang K, Larsen JS, McCarthy S, Chowdhury S; TITAN Investigators. Apalutamide for Metastatic, Castration-Sensitive Prostate Cancer. N Engl J Med. 2019 Jul 4;381(1):13-24. doi: 10.1056/NEJMoa1903307. Epub 2019 May 31.

    PubMed 31150574

  • James ND, Sydes MR, Clarke NW, Mason MD, Dearnaley DP, Spears MR, Ritchie AW, Parker CC, Russell JM, Attard G, de Bono J, Cross W, Jones RJ, Thalmann G, Amos C, Matheson D, Millman R, Alzouebi M, Beesley S, Birtle AJ, Brock S, Cathomas R, Chakraborti P, Chowdhury S, Cook A, Elliott T, Gale J, Gibbs S, Graham JD, Hetherington J, Hughes R, Laing R, McKinna F, McLaren DB, O'Sullivan JM, Parikh O, Peedell C, Protheroe A, Robinson AJ, Srihari N, Srinivasan R, Staffurth J, Sundar S, Tolan S, Tsang D, Wagstaff J, Parmar MK; STAMPEDE investigators. Addition of docetaxel, zoledronic acid, or both to first-line long-term hormone therapy in prostate cancer (STAMPEDE): survival results from an adaptive, multiarm, multistage, platform randomised controlled trial. Lancet. 2016 Mar 19;387(10024):1163-77. doi: 10.1016/S0140-6736(15)01037-5. Epub 2015 Dec 21.

    PubMed 26719232

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ADT plus only 12 months of ARPI and ADT plus continued ARPI in people with Prostate Cancer, run by Nick Beije at 26 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 7 inclusion and 5 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 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 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?

Contact Dr. N. Beije (+31010 704 0704, n.beije@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to clinical progression free survival (cPFS) in both arms. (time frame: From inclusion to the last day of treatment or moment of progression (whichever occurs first). Subjects will participate for 5 years, after randomization. In total, patients will participate for 6 years.). 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 NCT07260435, which also lists 16 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 3 Dec 2025.

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