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Oligoprogressive Prostate CancerPSMA-OLIGO-PRONCT07691697

PSMA PET-Staged Comprehensive Progression-Directed Radiotherapy for Limited Progression in Prostate Cancer

An observational study of Oligoprogressive Prostate Cancer and Metastatic Prostate Cancer, run by Affidea Nu-med Center of Oncological DIagnostics and Therapy at 1 site in Poland.

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

PSMA-OLIGO-PRO is a multicenter, ambispective, observational real-world evidence registry of adults with metastatic hormone-sensitive or metastatic castration-resistant prostate cancer who develop a limited number of progressing metastatic lesions during active systemic therapy and are considered for comprehensive… Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Comprehensive Progression-Directed Radiotherapy
Type of treatment
Surgery or procedure
How many people
1,000 participants
Where
1 sitePoland
Study dates
26 Jun 2026to 30 Dec 2031
How long will I take part?
5 Years
Phase
Observational
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

Study population: Adults with histologically confirmed prostate adenocarcinoma and metastatic hormone-sensitive or metastatic castration-resistant disease receiving active systemic therapy at participating centers. Before amendment activation, eligible metastatic progression is limited to 1-5 lesions. After site-specific amendment activation, prospective candidates have 1-10 qualifying progressing metastatic lesions on baseline PSMA PET and undergo formal review to determine whether every metastatic and local progressing site can be treated with comprehensive PDRT. Otherwise, eligible local-only cases form a separate descriptive stratum.

Who may be able to join

None listed.

Who cannot join

  • Limited progression defined only by conventional CT, MRI, or bone scintigraphy without a qualifying PSMA PET examination.
  • More than five qualifying progressing metastatic lesions for retrospective or pre-amendment inclusion.
  • More than 10 qualifying progressing metastatic lesions after amendment activation.
  • Diffuse, non-enumerable, or rapidly progressive disease that is not considered suitable for comprehensive lesion-directed radiotherapy.
  • Any known active metastatic or local progressing site that cannot be included in the comprehensive PDRT plan.
  • Clinical deterioration or an urgent systemic-treatment indication that makes comprehensive PDRT inappropriate or unsafe.
Show all 9Show fewer
  • Radiotherapy delivered solely with palliative symptom-control intent rather than definitive progression-directed local-control intent.
  • For prospective participation, inability to complete the approved consent process.
  • For retrospective cases, missing baseline imaging or core dates such that metastatic burden, PDRT exposure, or at least one outcome or censoring time cannot be determined reliably.

Trial locations and contacts

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

Mateusz Bilski, MD, PhD contact

84 535 99 10 ext. +48

mateusz.bilski@affidea.com

Paulina Kleban contact

84 535 99 10 ext. +48

paulina.kleban@affidea.com

Poland1 site, 1 recruiting

  • Affidea Nu-Med Cancer Diagnostics and Therapy Center

    Zamość, Lublin Voivodeship, 22-400

    Mateusz Bilski, MD, PhD, 84 535 99 10 ext. +48, mateusz.bilski@affidea.com

    Paulina Kleban, 84 535 99 10 ext. +48, paulina.kleban@affidea.com

    Recruiting

Other trials in Poland

About this study

Official title: Outcomes After PSMA PET-Staged Comprehensive Progression-Directed Radiotherapy for Limited Progression in Prostate Cancer: An Ambispective Multicenter Registry With a Prospective 1-10-Metastasis Cohort

PSMA-OLIGO-PRO is a multicenter, ambispective, observational real-world evidence registry of adults with metastatic hormone-sensitive or metastatic castration-resistant prostate cancer who develop a limited number of progressing metastatic lesions during active systemic therapy and are considered for comprehensive progression-directed radiotherapy (PDRT) in routine clinical care. The registry includes retrospective cases treated before June 26, 2026, and prospective cases enrolled from June 26, 2026, onward. Before the site-specific protocol amendment takes effect, the metastatic-lesion ceiling is 1-5. After the amendment takes effect, prospective candidates with 1-10 qualifying progressing metastatic lesions on baseline PSMA PET/CT or PSMA PET/MRI may be included. Metastatic burden is prespecified as 1-5 lesions, representing classical oligoprogression, or 6-10 lesions, representing exploratory, PSMA PET-defined, limited progression. Intraprostatic and prostate-bed progressing foci are recorded separately from the metastatic count and must also be included in the comprehensive PDRT plan. Otherwise eligible local-only episodes form a separate descriptive stratum. All qualifying metastatic and locally progressing sites must be deemed technically amenable to definitive-intent PDRT before prospective analytic-cohort enrollment. The registry does not assign imaging, systemic therapy, or radiotherapy; these clinical decisions are made independently by the treating team in routine care. A qualifying baseline PSMA PET and documentation of comprehensive treatability are required for inclusion.

The primary endpoint is time to next systemic therapy in the continuation-plan treatment-start set. Key secondary outcomes include PDRT initiation and comprehensive implementation, time to widespread or non-PDRT-amenable progression, classical time to polymetastatic progression in the baseline 1-5 cohort, radiographic progression-free survival, lesion-level local control, overall survival, and treatment-related toxicity. The prespecified 1-5 versus 6-10 comparison is restricted to concurrent post-amendment prospective participants and is exploratory.

Read the detailed description

PSMA-OLIGO-PRO is a multicenter, ambispective, observational real-world evidence registry of adults with metastatic prostate adenocarcinoma who develop limited progression during active systemic therapy and are considered for comprehensive progression-directed radiotherapy (PDRT) in routine clinical practice. The study does not assign imaging, systemic therapy, or radiotherapy. Decisions to obtain PSMA PET, to determine the pre-PDRT systemic-management plan, and to consider comprehensive PDRT are made independently of registry participation. The registry comprises three calendar-defined data-origin cohorts: (1) a retrospective classical-burden cohort treated before June 26, 2026, with 1-5 qualifying progressing metastatic lesions; (2) a prospective pre-amendment classical-burden cohort enrolled from June 26, 2026, until the amendment becomes effective at each site, with 1-5 qualifying progressing metastatic lesions; and (3) a post-amendment prospective cohort with 1-10 qualifying progressing metastatic lesions. Within the post-amendment cohort, burden is prespecified as 1-5 versus 6-10 metastatic lesions. Six to ten lesions constitute an exploratory expanded-burden limited-progression stratum and are not presented as an established consensus definition of oligoprogression. Baseline PSMA PET/CT or PSMA PET/MRI is mandatory for every included episode. For post-amendment prospective enrollment, the qualifying PSMA PET must be performed within 60 days before enrollment, and index PDRT must be planned to begin within 60 days after the scan. Repeat staging or documented multidisciplinary reconfirmation is required if this interval is exceeded or if an intervening clinical event or systemic-treatment change could alter metastatic burden. The eligibility ceiling and burden stratum are based only on qualifying progressing metastatic lesions. Intraprostatic and prostate-bed progressing foci are recorded separately, do not count toward the metastatic ceiling, and must also be included in the comprehensive PDRT plan. Otherwise eligible patients with zero progressing metastases and isolated local or prostate-bed progression form a separate descriptive stratum and do not contribute to the metastatic-burden comparison or metastatic-threshold progression endpoints. Before prospective analytic-cohort enrollment, all qualifying metastatic and local progressing sites must be judged technically amenable to definitive-intent PDRT. Candidates deemed feasible are enrolled before the first PDRT fraction. Prospectively enrolled participants who do not start or do not complete all planned PDRT remain in the enrolled and implementation denominators. Only participants receiving at least one PDRT fraction enter the prospective safety set and the treatment-start clinical-outcome sets. PDRT may include stereotactic body radiotherapy, moderately hypofractionated external-beam radiotherapy, high-dose-rate or low-dose-rate brachytherapy, combined external-beam and brachytherapy, or mixed-modality treatment, according to institutional standards. Every qualifying metastatic and local progressing site must be included in a predefined index treatment strategy. For post-amendment prospective participants, PDRT initiation is assessed within 60 days after enrollment, and comprehensive implementation requires definitive-intent treatment of every locked baseline site within 60 days after the first index fraction. The primary endpoint is time to next systemic therapy (TTNS) in treatment-start participants whose pre-PDRT management plan was continuation of the same systemic regimen and who had not initiated a new systemic therapy line before the first PDRT fraction. Participants with a documented pre-PDRT plan to change or escalate systemic therapy are excluded from the primary TTNS estimand but remain eligible for other analyses. The broad TTNS definition used in the first posted registry version is retained as a supportive analysis for all treatment-start participants. The common expanded-state progression endpoint is time to widespread or non-PDRT-amenable progression (TWNP-10), defined by more than 10 new or unequivocally regrowing metastatic lesions, diffuse or non-enumerable progression, or a documented determination that all active progressing sites can no longer be safely treated with comprehensive definitive-intent local therapy. A supportive classical endpoint, TTPP-5, is restricted to participants with 1-5 metastatic lesions at baseline and retains the threshold of more than five progressing metastatic lesions or loss of comprehensive PDRT eligibility. Other outcomes include radiographic progression-free survival, lesion-level local control, overall survival, repeat limited progression, subsequent lesion-directed therapy, PDRT initiation and comprehensive implementation, disease trajectory, and acute and late treatment-related adverse events graded according to CTCAE version 5.0. The primary 1-5 versus 6-10 metastatic-burden comparison is limited to concurrent post-amendment prospective participants and uses endpoint-specific denominators. All comparisons are exploratory and estimate associations rather than causal treatment effects.

The coordinating center uses a controlled data dictionary and prespecified edit checks for date order, metastatic-count consistency, cohort assignment, lesion-to-treatment linkage, dose and fraction plausibility, endpoint derivation, and duplicate records. Data queries are sent to participating sites for correction or documented resolution. Selected post-amendment records, enriched for 6-10 metastases and discordant disease, may undergo source-data, imaging, and treatment-completeness review. Missingness is reported by data-origin cohort and burden stratum, and time-to-event observations without an event are censored at the last adequate assessment. The statistical analysis plan will be finalized before the comparative post-amendment data lock.

Being tested
Comprehensive Progression-Directed Radiotherapy
Keywords
PSMA PET, Oligoprogression, Prostate Cancer, Progression-Directed Radiotherapy, Stereotactic Body Radiotherapy, Brachytherapy, Metastasis-Directed Therapy, Castration-Resistant Prostate Cancer, Hormone-Sensitive Prostate Cancer, Time to Next Systemic Therapy, Real-World Evidence, Ambispective Registry, Prospective Registry, Expanded-burden limited progression, 6-10 metastatic lesions, Comprehensive progression-directed radiotherapy
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • Comprehensive Progression-Directed RadiotherapyRadiation

    Also called PDRT, Stereotactic Body Radiotherapy, SBRT, Brachytherapy

    Observed routine-care exposure includes definitive-intent radiotherapy planned for every qualifying metastatic site and for local or prostate-bed progressing sites identified in the index episode. Treatment may include stereotactic body radiotherapy, moderately hypofractionated external-beam radiotherapy, high-dose-rate or low-dose-rate brachytherapy, combined external-beam and brachytherapy, or mixed-modality radiotherapy. The registry does not assign treatment. Treatment modality, dose, fractionation, timing, site-level completion, and reasons for non-start or incomplete treatment are recorded.

Study groups in NCT07691697
Study groupRoleWhat they receive
PSMA PET-Staged Limited-Progression Registry CohortA single-observational registry cohort comprises adults with prostate cancer who have limited progression during active systemic therapy and are considered for comprehensive PDRT in routine clinical care. Data origin is classified as retrospective classical burden, prospective pre-amendment classical burden, or prospective post-amendment. In the post-amendment cohort, metastatic burden is prespecified as 1-5 or 6-10 qualifying progressing metastases. Prospectively enrolled feasible candidates remain in the cohort if PDRT does not start or is incomplete. PDRT is not assigned by the registry.
Receives: Radiation: Comprehensive Progression-Directed Radiotherapy

What is being measured

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

  1. Time to Next Systemic Therapy in the Continuation-Plan Treatment-Start Set

    Time from the first PDRT fraction to initiation of the first new systemic anticancer therapy line among participants who receive at least one PDRT fraction, whose management plan documented before PDRT was continuation of the same systemic regimen, and who had not initiated a new systemic line before the first PDRT fraction. Death before initiation of a new line is treated as a competing event; otherwise, participants are censored at the last adequate assessment.

    Measured: From first index PDRT fraction to a new systemic therapy line, death, last adequate assessment, or study data cutoff, up to 5 years

Secondary outcomes (9)

  1. Classical Time to Polymetastatic Progression (TTPP-5)

    Supportive endpoint restricted to participants with 1-5 qualifying progressing metastases at baseline. Time to more than five new or unequivocally regrowing qualifying metastatic lesions at one assessment or to disease that is no longer safely amenable to comprehensive PDRT. Participants entering with 6-10 metastases do not contribute. Death without the progression state is treated as a competing event.

    Measured: From first index PDRT fraction to the event, death, last adequate assessment, or study data cutoff, up to 5 years

  2. Radiographic Progression-Free Survival

    Time from the first index PDRT fraction to radiographic progression at any site or death from any cause, whichever occurs first. Imaging modality and assessment date are recorded. Progression based only on an unconfirmed change in PSMA uptake is not accepted unless it meets the protocol confirmation criteria.

    Measured: From first index PDRT fraction to radiographic progression, death, last adequate assessment, or study data cutoff, up to 5 years

  3. Overall Survival

    Time from the first index PDRT fraction to death from any cause. Participants alive at the last known follow-up are censored on that date.

    Measured: From first index PDRT fraction to death, last known follow-up, or study data cutoff, up to 5 years

  4. Lesion-Level Local Control

    Time from completion of PDRT for an individual treated lesion to unequivocal in-field progression of that lesion. Lesions are linked to participants and analyzed with methods that account for within-participant clustering. Death without local failure is treated as a competing event.

    Measured: From completion of PDRT for each lesion to local failure, death, last adequate assessment, or study data cutoff, up to 5 years

  5. Acute and Late Treatment-Related Adverse Events

    Number and proportion of prospectively enrolled participants who receive at least one index PDRT fraction and experience treatment-related adverse events graded by CTCAE version 5.0. Acute events occur through day 90 after treatment initiation and late events occur after day 90. Maximum grade, serious events, grade 2 or higher events, grade 3 or higher events, and selected site-specific toxicities are summarized. Retrospectively ascertained toxicity is reported separately when adequate.

    Measured: From first index PDRT fraction through day 90 for acute events and from day 91 through study data cutoff, up to 5 years, for late events

  6. Time to First Repeat Limited-Progression Episode

    Time from the first index PDRT fraction to the first subsequent limited-progression episode with no more than 10 new or unequivocally regrowing qualifying metastatic lesions at one assessment and with every active progressing metastatic and local site judged technically amenable to comprehensive PDRT. Death before repeat limited progression is treated as a competing event; otherwise participants are censored at the last adequate assessment.

    Measured: From first index PDRT fraction to repeat limited progression, death, last adequate assessment, or study data cutoff, up to 5 years

  7. Time to Next Systemic Therapy in All Treatment-Start Participants

    Supportive analysis of time from the first fraction of index PDRT to initiation of the first new systemic anticancer therapy line among all participants who receive at least one PDRT fraction, regardless of the pre-PDRT intended systemic-management strategy. This outcome preserves the population scope of the first posted registry version. Death before a new line is treated as a competing event; otherwise participants are censored at the last adequate assessment.

    Measured: From first index PDRT fraction to a new systemic therapy line, death, last adequate assessment, or study data cutoff, up to 5 years

  8. Time to Widespread or Non-PDRT-Amenable Progression (TWNP-10)

    Time to the earliest of more than 10 new or unequivocally regrowing qualifying metastatic lesions at one assessment; diffuse, confluent, or otherwise non-enumerable progression; or a documented multidisciplinary determination that all active progressing sites can no longer be safely treated with comprehensive definitive-intent local therapy. Death without this progression state is treated as a competing event.

    Measured: From first index PDRT fraction to the event, death, last adequate assessment, or study data cutoff, up to 5 years

  9. Time to First Subsequent Lesion-Directed Therapy

    Time from the first index PDRT fraction to initiation of the first subsequent local treatment course for repeat limited progression. Participants without subsequent lesion-directed therapy are censored at the last adequate assessment.

    Measured: From first index PDRT fraction to subsequent lesion-directed therapy, last adequate assessment, or study data cutoff, up to 5 years

Timeline

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

  1. First posted9 Jul 2026
  2. Study start26 Jun 2026
  3. Primary completion30 Dec 2030 (estimated)
  4. Study completion30 Dec 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
1,000 participants (estimated)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT07691697
Sponsor's protocol ID
PSMA-OLIGO-PRO
Acronym
PSMA-OLIGO-PRO
Status last verified
Sep 2026
First submitted
28 Jun 2026
Last updated
17 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data underlying future publications may include data-origin cohort, locked progressing-metastasis count, 1-5 or 6-10 burden stratum, separate local or prostate-bed site count, PSMA PET characteristics, lesion-level PDRT delivery and completion, pre-PDRT systemic-management plan, follow-up, progression, survival, and toxicity outcomes. Screening-log data from individuals not enrolled in the registry will not be shared unless specifically permitted by the approved lawful basis. Sharing remains subject to steering-group approval, applicable ethics and data-protection requirements, and a data-sharing agreement.

Publications

  • Armstrong AJ, Morris MJ, Abida W, Aggarwal RR, Antonarakis ES, Attard G, Beltran H, Bryce A, Carducci MA, Cheng HH, Chen DL, Chi KN, Childs DS, Dahut W, Emmett L, Fizazi K, Gafita A, George DJ, Hermann K, Hofman MS, Hope T, Hussain M, Kelly WK, Kessler E, Kuo PH, Lang J, Liu G, Marshall CH, Morgans AK, McKay RR, Nanus D, Nelson P, Paller C, Reichert ZR, Ryan CJ, Sartor AO, Schoder H, Schwartz LH, Sharifi N, Stadler WM, Stein M, Sternberg CN, Szmulewitz RZ, Tagawa ST, Sokolova AO, Wyatt AW, Yamoah K, Yu EY, Halabi S, Scher HI; PCWG4 Writing Group. Trial Design and Objectives for Patients With Prostate Cancer: Recommendations From the Prostate Cancer Working Group 4. J Clin Oncol. 2026 May;44(13):1249-1265. doi: 10.1200/JCO-25-02834. Epub 2026 Feb 26.

    PubMed 41744290

  • Ashram S, Bahig H, Barry A, Blanchette D, Celinksi A, Chung P, Darko J, Donath D, Doucet R, Erickson A, Giuliani M, Gopaul D, Hipwell S, Javor J, Kuk J, Lindsay P, Millman B, Oliver M, Pearce A, Russell C, Senthi S, Vu T, Warner A, Gaede S, Palma DA. Planning Trade-offs for SABR in Patients With 4 to 10 Metastases: A Substudy of the SABR-COMET-10 Randomized Trial. Int J Radiat Oncol Biol Phys. 2022 Dec 1;114(5):1011-1015. doi: 10.1016/j.ijrobp.2022.05.035. Epub 2022 Jun 3. No abstract available.

    PubMed 35667527

  • Palma DA, Olson R, Harrow S, Correa RJM, Schneiders F, Haasbeek CJA, Rodrigues GB, Lock M, Yaremko BP, Bauman GS, Ahmad B, Schellenberg D, Liu M, Gaede S, Laba J, Mulroy L, Senthi S, Louie AV, Swaminath A, Chalmers A, Warner A, Slotman BJ, de Gruijl TD, Allan A, Senan S. Stereotactic ablative radiotherapy for the comprehensive treatment of 4-10 oligometastatic tumors (SABR-COMET-10): study protocol for a randomized phase III trial. BMC Cancer. 2019 Aug 19;19(1):816. doi: 10.1186/s12885-019-5977-6.

    PubMed 31426760

  • Eule CJ, Candelario N, Nath SK, Robin TP. Time to Next Systemic Therapy After Stereotactic Body Radiation Therapy for Oligoprogressive Metastatic Castrate-Resistant Prostate Cancer. Adv Radiat Oncol. 2024 Oct 20;9(12):101655. doi: 10.1016/j.adro.2024.101655. eCollection 2024 Dec.

    PubMed 39620140

  • Alzibdeh A, Wahbeh L, Taha SA, Qambar M, Al Mousa A, Khader J, Abuhijla F, Erjan A, Alnsour A, Mohamad I, Sharaf B, Ahmed S, Mheid S, Abdel-Razeq H, Asha W. Metastasis-Directed Stereotactic Body Radiation Therapy in Oligometastatic and Oligoprogressive Solid Malignancy: Outcomes and Effect on Systemic Treatment. JCO Glob Oncol. 2025 Oct;11:e2500004. doi: 10.1200/GO-25-00004. Epub 2025 Oct 3.

    PubMed 41043100

  • Lievens Y, Guckenberger M, Gomez D, Hoyer M, Iyengar P, Kindts I, Mendez Romero A, Nevens D, Palma D, Park C, Ricardi U, Scorsetti M, Yu J, Woodward WA. Defining oligometastatic disease from a radiation oncology perspective: An ESTRO-ASTRO consensus document. Radiother Oncol. 2020 Jul;148:157-166. doi: 10.1016/j.radonc.2020.04.003. Epub 2020 Apr 22.

    PubMed 32388150

  • Guckenberger M, Lievens Y, Bouma AB, Collette L, Dekker A, deSouza NM, Dingemans AC, Fournier B, Hurkmans C, Lecouvet FE, Meattini I, Mendez Romero A, Ricardi U, Russell NS, Schanne DH, Scorsetti M, Tombal B, Verellen D, Verfaillie C, Ost P. Characterisation and classification of oligometastatic disease: a European Society for Radiotherapy and Oncology and European Organisation for Research and Treatment of Cancer consensus recommendation. Lancet Oncol. 2020 Jan;21(1):e18-e28. doi: 10.1016/S1470-2045(19)30718-1.

    PubMed 31908301

  • Patel P, Dreibe S, Attard G, Cole A, Diez P, Frew J, Guevara J, Levine D, McDonald F, Mullassery V, Murray J, Parker C, Palaniappan N, Pathmanathan A, Reid A, Suh YE, Syndikus I, Tirona A, Tran A, Tunariu N, van As NJ, Wylie J, Tree AC. Stereotactic Body Radiation Therapy for Oligoprogressive Disease in Androgen-Suppressed Prostate Cancer: Primary Endpoint Analysis of the TRAP Trial. Int J Radiat Oncol Biol Phys. 2026 May 1;125(1):285-294. doi: 10.1016/j.ijrobp.2025.02.046. Epub 2025 Mar 9.

    PubMed 40068778

  • Nikitas J, Castellanos Rieger A, Farolfi A, Seyedroudbari A, Kishan AU, Nickols NG, Steinberg ML, Valle LF, Rettig M, Czernin J, Calais J. Prostate-Specific Membrane Antigen PET/CT-Guided, Metastasis-Directed Radiotherapy for Oligometastatic Castration-Resistant Prostate Cancer. J Nucl Med. 2024 Sep 3;65(9):1387-1394. doi: 10.2967/jnumed.124.267922.

    PubMed 39089811

  • Rans K, Joniau S, Berghen C, Goffin K, Dumez H, Haustermans K, De Meerleer G. Progression-directed Therapy in Oligoprogressive Castration-resistant Prostate Cancer: Final Results from the Prospective, Single-arm, Phase 2 MEDCARE Trial. Eur Urol Oncol. 2024 Dec;7(6):1441-1450. doi: 10.1016/j.euo.2024.04.003. Epub 2024 Apr 25.

    PubMed 38664137

  • Deek MP, Taparra K, Phillips R, Velho PI, Gao RW, Deville C, Song DY, Greco S, Carducci M, Eisenberger M, DeWeese TL, Denmeade S, Pienta K, Paller CJ, Antonarakis ES, Olivier KR, Park SS, Tran PT, Stish BJ. Metastasis-directed Therapy Prolongs Efficacy of Systemic Therapy and Improves Clinical Outcomes in Oligoprogressive Castration-resistant Prostate Cancer. Eur Urol Oncol. 2021 Jun;4(3):447-455. doi: 10.1016/j.euo.2020.05.004. Epub 2020 Jun 11.

    PubMed 32536574

Questions about this trial

What is this clinical trial studying?

An observational study of Oligoprogressive Prostate Cancer and Metastatic Prostate Cancer, run by Affidea Nu-med Center of Oncological DIagnostics and Therapy at 1 site in Poland.

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 0 inclusion and 9 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 17 Sep 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 Poland. 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.

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 Mateusz Bilski, MD, PhD (84 535 99 10 ext. +48, mateusz.bilski@affidea.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Next Systemic Therapy in the Continuation-Plan Treatment-Start Set (time frame: From first index PDRT fraction to a new systemic therapy line, death, last adequate assessment, or study data cutoff, up to 5 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 NCT07691697, which also lists 11 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 17 Sep 2026.

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