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Prostate Cancer (Adenocarcinoma)Phase 1NCT07316686

Phase I Study of Docetaxel and 177-Lutetium-PSMA-I&T in First-Line Treatment for Patients With Metastatic Castration-Resistant Prostate Adenocarcinoma

A Phase 1 study testing Docetaxel 50mg/m2, Docetaxel 60mg/m2 and Docetaxel 75 mg/m² in people with Prostate Cancer (Adenocarcinoma), run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.

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

This is a Phase I, open-label, single-center study evaluating the safety, tolerability, and recommended Phase II dose of docetaxel when combined with a fixed dose of 177-Lutetium-PSMA-I\&T in chemotherapy-naïve patients with metastatic castration-resistant prostate cancer (mCRPC). Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer (Adenocarcinoma)
What is being tested?
Docetaxel 50mg/m2, Docetaxel 60mg/m2 and Docetaxel 75 mg/m²
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteBrazil
Study dates
16 Jun 2026to Dec 2026
Phase
Phase 1
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

  • Men aged 18 years or older.
  • Histological or cytological diagnosis of prostate adenocarcinoma. The presence of intraductal or cribriform carcinoma will be allowed.
  • Presence of metastatic disease on conventional imaging exams (bone scintigraphy and/or CT scan or MRI).
  • Patients with castration-resistant disease, defined as testosterone <50 ng/mL in the context of prior orchiectomy or ongoing androgen deprivation therapy (ADT) with LHRH agonists or antagonists, plus at least one of the criteria below:
  • PSA ≥2.0 ng/mL with at least two consecutive PSA rises at intervals of at least 1 week.
  • Radiologic progression defined by the investigator.
Show all 23Show fewer
  • Clinical progression defined by the investigator.
  • Performance status per the Eastern Cooperative Oncology Group (ECOG) equal to 0 or 1.
  • Willingness to continue ongoing ADT.
  • Adequate organ function as defined below:
  • Parameter Requirement
  • Neutrophils ≥ 1,500/µL
  • Hemoglobin ≥ 12 g/dL
  • Platelets ≥ 100,000/µL
  • Creatinine ≤ 1.5 x upper limit of normal
  • Potassium > 3.5 mmol/L and <5.0 mmol/L
  • Total Bilirubin ≤ ULN (unless Gilbert's disease)
  • AST (TGO) ≤ 2.5 x ULN
  • ALT (TGP) ≤ 2.5 x ULN
  • 68Ga-PSMA-PET/CT performed during the screening phase showing metastatic (extraprosthetic and extrapelvic) disease with radiotracer uptake and:
  • SUVmax ≥20 in at least one site;
  • SUVmax >10 in all other measurable metastatic sites.
  • Lesions with uptake at least 1.5 times greater than hepatic background will be considered measurable.

Who cannot join

  • Presence of any small-cell or neuroendocrine component of prostate carcinoma.
  • Prior receipt of chemotherapy or radiopharmaceuticals in the castration-resistant setting.
  • Presence of another active malignancy requiring treatment or a cancer diagnosis within the past 5 years. Carcinoma in situ of any site, squamous cell carcinoma of the skin, basal cell carcinoma of the skin, or papillary bladder tumors will be allowed if previously treated.
  • Severe urinary incontinence at the investigator's discretion.
  • 18F-FDG-PET/CT will be performed during screening and will be considered exclusionary if there is discordance with the 68Ga-PSMA-PET/CT. Discordance is defined as FDG-hypermetabolic lesions with absent or low PSMA uptake (SUVmax <10) in more than 50% of measurable metastatic lesions.
  • Patients with brain metastases visible on 68Ga-PSMA-PET/CT.

Trial locations and contacts

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

Research Center, Assistant contact

+55 11 3893-3566

icesp.pesqclinica@hc.fm.usp.br

Brazil1 site, 1 recruiting

  • Instituto do Câncer do Estado de São Paulo - ICESP

    São Paulo, 01246000

    Research Center, Assistant, +55 11 3893-3566, icesp.pesqclinica@hc.fm.usp.br

    Recruiting

Other trials in Brazil

About this study

This is a Phase I, open-label, single-center study evaluating the safety, tolerability, and recommended Phase II dose of docetaxel when combined with a fixed dose of 177-Lutetium-PSMA-I\&T in chemotherapy-naïve patients with metastatic castration-resistant prostate cancer (mCRPC). Patients will receive standard androgen deprivation therapy, docetaxel at escalating doses (50 mg/m², 60 mg/m², 75 mg/m² every 3 weeks), and 177Lu-PSMA-I\&T at a fixed dose of 7.4 GBq every 6 weeks (up to 4 cycles). A 3+3 dose escalation design will be employed. Secondary endpoints include safety profile, treatment-limiting toxicities, treatment completion rate, and delayed toxicity. Exploratory endpoints include PSA response, radiographic progression-free survival (rPFS), and PERCIST-based response rate.

Read the detailed description

This is a Phase I, open-label, single-center study designed to evaluate the safety, tolerability, and to determine the recommended Phase II dose (RP2D) of docetaxel when combined with a fixed dose of 177Lu-PSMA-I\&T in patients with metastatic castration-resistant prostate cancer (mCRPC) who have not previously received chemotherapy for castration-resistant disease.

All participants will continue receiving androgen deprivation therapy (ADT) throughout the study. The treatment regimen includes docetaxel administered intravenously every 3 weeks at escalating doses of 50 mg/m², 60 mg/m², and 75 mg/m² (up to 10 cycles), combined with 177Lu-PSMA-I\&T at a fixed dose of 7.4 GBq every 6 weeks, for up to 4 cycles. A traditional 3+3 dose-escalation design will be used, allowing sequential patient enrollment and assessment of dose-limiting toxicities (DLTs) during the first 3 weeks to establish the optimal docetaxel dose for future studies.

Treatment will continue until completion of 10 cycles of docetaxel and 4 cycles of 177Lu-PSMA-I\&T, or until disease progression, unacceptable toxicity, or withdrawal of consent. Imaging exams, including SPECT, will be performed after each lutetium administration for dosimetry assessment.

The primary endpoint is the determination of the RP2D of docetaxel when combined with 177Lu-PSMA-I\&T. Secondary endpoints include evaluation of the overall safety profile, incidence of DLTs, treatment completion rate, and monitoring of late toxicities. Exploratory endpoints include PSA response (≥50% decline), radiographic progression-free survival (rPFS), and response rate based on PERCIST criteria using PSMA-PET.

Patients will undergo imaging assessments every 6 weeks (±7 days), including PSMA-PET/CT, FDG-PET/CT, CT scans, and bone scintigraphy. Laboratory tests will be performed every 3 weeks during treatment and every 6 weeks during the post-treatment follow-up, for up to 24 weeks.

Key inclusion criteria include: male patients aged 18 years or older, histologically confirmed adenocarcinoma of the prostate, documented metastatic disease by conventional imaging, castration-resistant disease with testosterone levels <50 ng/mL, ECOG performance status of 0-1, adequate organ function, and positive 68Ga-PSMA-PET/CT uptake according to protocol-defined parameters.

Key exclusion criteria include: presence of small-cell or neuroendocrine tumor components, prior chemotherapy or radiopharmaceuticals for castration-resistant disease, recent or active second malignancies, significant discordance between FDG-PET/CT and PSMA-PET/CT, visible brain metastases, severe urinary incontinence, or any clinical condition that, in the investigator's judgment, would contraindicate the use of docetaxel or 177Lu-PSMA-I\&T. Full details of inclusion and exclusion criteria are provided in the study protocol.

This study aims to establish the optimal dose of docetaxel in combination with 177Lu-PSMA-I\&T and to generate preliminary safety and efficacy data for treating patients with metastatic castration-resistant prostate cancer.

Being tested
Docetaxel 50mg/m2, Docetaxel 60mg/m2, Docetaxel 75 mg/m², 177Lu-PSMA-I&T
Medical subject headings
Prostatic Neoplasms, Adenocarcinoma

What participants receive

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

  • Docetaxel 50mg/m2Drug

    Intravenous, 50 mg/m², every 3 weeks, up to 10 cycles

  • Docetaxel 60mg/m2Drug

    Intravenous, 60 mg/m², every 3 weeks, up to 10 cycles

  • Docetaxel 75 mg/m²Drug

    Intravenous, 75 mg/m², every 3 weeks, up to 10 cycles

  • 177Lu-PSMA-I&TRadiation

    Intravenous administration at a fixed dose of 7.4 GBq every 6 weeks, up to 4 cycles.

Study groups in NCT07316686
Study groupRoleWhat they receive
Docetaxel 50 mg/m² + 177Lu-PSMA-I&TExperimentalPatients will receive docetaxel 50 mg/m² IV every 3 weeks plus 177Lu-PSMA-I\&T 7.4 GBq IV every 6 weeks. all patients will continue androgen deprivation therapy.
Receives: Drug: Docetaxel 50mg/m2; Radiation: 177Lu-PSMA-I&T
Docetaxel 60 mg/m² + 177Lu-PSMA-I&TExperimentalPatients will receive docetaxel 60 mg/m² IV every 3 weeks plus 177Lu-PSMA-I\&T 7.4 GBq IV every 6 weeks. all patients will continue androgen deprivation therapy.
Receives: Drug: Docetaxel 60mg/m2; Radiation: 177Lu-PSMA-I&T
Docetaxel 75 mg/m² + 177Lu-PSMA-I&TExperimentalPatients will receive docetaxel 75 mg/m² IV every 3 weeks plus 177Lu-PSMA-I\&T 7.4 GBq IV every 6 weeks. all patients will continue androgen deprivation therapy.
Receives: Drug: Docetaxel 75 mg/m²; Radiation: 177Lu-PSMA-I&T

What is being measured

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

  1. Recommended Phase II Dose (RP2D) of docetaxel in combination with 177Lu-PSMA-I&T

    Determination of the recommended Phase II dose using a standard 3+3 dose-escalation design.

    Measured: First 3 weeks

Secondary outcomes (4)

  1. Incidence of dose-limiting toxicities (DLTs)

    Incidence of dose-limiting toxicities (DLTs)

    Measured: first 3 weeks.

  2. Overall safety profile (CTCAE v5.0)

    Overall safety profile (CTCAE v5.0)

    Measured: Up to 24 weeks

  3. Treatment completion rate

    Treatment completion rate (≥4 doses of lutetium and ≥7 doses of docetaxel)

    Measured: Up to 24 weeks

  4. Incidence of late toxicities

    Incidence of late toxicities

    Measured: Up to 24 weeks post-treatment

Timeline

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

  1. First posted5 Jan 2026
  2. Study start16 Jun 2026
  3. Primary completionSep 2026 (estimated)
  4. Study completionDec 2026 (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 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
A classic 3+3 dose-escalation design will be used to sequentially assign participants to escalating dose levels of docetaxel combined with fixed-dose 177Lu-PSMA-I\&T.
Masking
None (open label)
Enrolment
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07316686
Sponsor's protocol ID
NP2028
Status last verified
Aug 2026
First submitted
26 Sep 2025
Last updated
25 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: It has been decided not to share individual participant data (IPD) related to the study for several reasons. Protecting the privacy of participants is a priority. Sharing IPD may expose sensitive information that, even when de-identified, can be traced back to individuals. Furthermore, the complexity of the data makes sharing challenging without the risk of misunderstandings or misinterpretations, which could compromise the integrity of the research. Sharing IPD without the explicit consent of participants may violate ethical principles of respect and protection. There is also a need to comply with regulatory guidelines governing data sharing to avoid potential legal issues. Finally, the focus will be on disseminating aggregated results that can benefit the scientific community and the public without compromising individual privacy.

Publications

  • Tannock IF, de Wit R, Berry WR, Horti J, Pluzanska A, Chi KN, Oudard S, Theodore C, James ND, Turesson I, Rosenthal MA, Eisenberger MA; TAX 327 Investigators. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med. 2004 Oct 7;351(15):1502-12. doi: 10.1056/NEJMoa040720.

    PubMed 15470213

  • INSTITUTO NACIONAL DO CÂNCER. Estatísticas de câncer. Disponível em: <https://www.inca.gov.br/numeros-de-cancer>. Acesso em: 4 mar. 2021.

  • Tagawa ST, Milowsky MI, Morris M, Vallabhajosula S, Christos P, Akhtar NH, Osborne J, Goldsmith SJ, Larson S, Taskar NP, Scher HI, Bander NH, Nanus DM. Phase II study of Lutetium-177-labeled anti-prostate-specific membrane antigen monoclonal antibody J591 for metastatic castration-resistant prostate cancer. Clin Cancer Res. 2013 Sep 15;19(18):5182-91. doi: 10.1158/1078-0432.CCR-13-0231. Epub 2013 May 28.

    PubMed 23714732

  • Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer Statistics, 2021. CA Cancer J Clin. 2021 Jan;71(1):7-33. doi: 10.3322/caac.21654. Epub 2021 Jan 12.

    PubMed 33433946

  • 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.

    PubMed 22894553

  • Scher HI, Solo K, Valant J, Todd MB, Mehra M. Prevalence of Prostate Cancer Clinical States and Mortality in the United States: Estimates Using a Dynamic Progression Model. PLoS One. 2015 Oct 13;10(10):e0139440. doi: 10.1371/journal.pone.0139440. eCollection 2015.

    PubMed 26460686

  • Scher HI, Heller G. Clinical states in prostate cancer: toward a dynamic model of disease progression. Urology. 2000 Mar;55(3):323-7. doi: 10.1016/s0090-4295(99)00471-9. No abstract available.

    PubMed 10699601

  • 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.

    PubMed 25601341

  • Rahbar K, Ahmadzadehfar H, Kratochwil C, Haberkorn U, Schafers M, Essler M, Baum RP, Kulkarni HR, Schmidt M, Drzezga A, Bartenstein P, Pfestroff A, Luster M, Lutzen U, Marx M, Prasad V, Brenner W, Heinzel A, Mottaghy FM, Ruf J, Meyer PT, Heuschkel M, Eveslage M, Bogemann M, Fendler WP, Krause BJ. German Multicenter Study Investigating 177Lu-PSMA-617 Radioligand Therapy in Advanced Prostate Cancer Patients. J Nucl Med. 2017 Jan;58(1):85-90. doi: 10.2967/jnumed.116.183194. Epub 2016 Oct 20.

    PubMed 27765862

  • Parker C, Nilsson S, Heinrich D, Helle SI, O'Sullivan JM, Fossa SD, Chodacki A, Wiechno P, Logue J, Seke M, Widmark A, Johannessen DC, Hoskin P, Bottomley D, James ND, Solberg A, Syndikus I, Kliment J, Wedel S, Boehmer S, Dall'Oglio M, Franzen L, Coleman R, Vogelzang NJ, O'Bryan-Tear CG, Staudacher K, Garcia-Vargas J, Shan M, Bruland OS, Sartor O; ALSYMPCA Investigators. Alpha emitter radium-223 and survival in metastatic prostate cancer. N Engl J Med. 2013 Jul 18;369(3):213-23. doi: 10.1056/NEJMoa1213755.

    PubMed 23863050

  • Nilsson S, Larsen RH, Fossa SD, Balteskard L, Borch KW, Westlin JE, Salberg G, Bruland OS. First clinical experience with alpha-emitting radium-223 in the treatment of skeletal metastases. Clin Cancer Res. 2005 Jun 15;11(12):4451-9. doi: 10.1158/1078-0432.CCR-04-2244.

    PubMed 15958630

  • Hofman MS, Emmett L, Sandhu S, Iravani A, Joshua AM, Goh JC, Pattison DA, Tan TH, Kirkwood ID, Ng S, Francis RJ, Gedye C, Rutherford NK, Weickhardt A, Scott AM, Lee ST, Kwan EM, Azad AA, Ramdave S, Redfern AD, Macdonald W, Guminski A, Hsiao E, Chua W, Lin P, Zhang AY, McJannett MM, Stockler MR, Violet JA, Williams SG, Martin AJ, Davis ID; TheraP Trial Investigators and the Australian and New Zealand Urogenital and Prostate Cancer Trials Group. [177Lu]Lu-PSMA-617 versus cabazitaxel in patients with metastatic castration-resistant prostate cancer (TheraP): a randomised, open-label, phase 2 trial. Lancet. 2021 Feb 27;397(10276):797-804. doi: 10.1016/S0140-6736(21)00237-3. Epub 2021 Feb 11.

    PubMed 33581798

  • Heck MM, Tauber R, Schwaiger S, Retz M, D'Alessandria C, Maurer T, Gafita A, Wester HJ, Gschwend JE, Weber WA, Schwaiger M, Knorr K, Eiber M. Treatment Outcome, Toxicity, and Predictive Factors for Radioligand Therapy with 177Lu-PSMA-I&T in Metastatic Castration-resistant Prostate Cancer. Eur Urol. 2019 Jun;75(6):920-926. doi: 10.1016/j.eururo.2018.11.016. Epub 2018 Nov 22.

    PubMed 30473431

  • Fizazi K, Scher HI, Molina A, Logothetis CJ, Chi KN, Jones RJ, Staffurth JN, North S, Vogelzang NJ, Saad F, Mainwaring P, Harland S, Goodman OB Jr, Sternberg CN, Li JH, Kheoh T, Haqq CM, de Bono JS; COU-AA-301 Investigators. Abiraterone acetate for treatment of metastatic castration-resistant prostate cancer: final overall survival analysis of the COU-AA-301 randomised, double-blind, placebo-controlled phase 3 study. Lancet Oncol. 2012 Oct;13(10):983-92. doi: 10.1016/S1470-2045(12)70379-0. Epub 2012 Sep 18.

    PubMed 22995653

  • de Bono JS, Oudard S, Ozguroglu M, Hansen S, Machiels JP, Kocak I, Gravis G, Bodrogi I, Mackenzie MJ, Shen L, Roessner M, Gupta S, Sartor AO; TROPIC Investigators. Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: a randomised open-label trial. Lancet. 2010 Oct 2;376(9747):1147-54. doi: 10.1016/S0140-6736(10)61389-X.

    PubMed 20888992

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Docetaxel 50mg/m2, Docetaxel 60mg/m2 and Docetaxel 75 mg/m² in people with Prostate Cancer (Adenocarcinoma), run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.

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 23 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 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 Research Center, Assistant (+55 11 3893-3566, icesp.pesqclinica@hc.fm.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recommended Phase II Dose (RP2D) of docetaxel in combination with 177Lu-PSMA-I&T (time frame: First 3 weeks). 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 NCT07316686, which also lists 17 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 25 Aug 2026.

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