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Prostate Cancer MetastaticNCT05530395

BAseLine TEstosterone as a Prognostic and/or Predictive bioMARKer in mHSPC

An observational study of Prostate Cancer Metastatic, run by Ignacio Puche Sanz at 3 sites in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Despite large amounts of basic-science data supporting a role for androgens in PCa pathogenesis, there are conflicting clinical data on the role of endogenous testosterone in human de novo PCa pathogenesis. Read more about this study

Who is it for?
Ages 18 to 89 years, men only
Conditions the study is for
Prostate Cancer Metastatic
What is being tested?
Testosterone levels
How many people
300 participants
Where
3 sitesSpain
Study dates
1 Jan 2023to 1 Jan 2026
Phase
Observational
Are there results?
None posted in the registry

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 to 89 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Study population: Metastatic hormone sensitive prostate cancer (mHSPC) patients diagnosed by any imaging test (at least CT and/or bone scan).

Who may be able to join

  • Metastatic hormone sensitive prostate cancer (mHSPC) patients diagnosed by any imaging test (at least CT and bone scan) including:
  • Any newly diagnosed mHSPC with no prior treatments.
  • Primarily treated PCa that have progressed to mHSPC with no prior ADT in the last 2 years.
  • Patients receiving ADT + EBRT as primary treatment will also be included.
  • Patients who agree to be followed prospectively according to routine clinical practice in the context of this study.

Who cannot join

  • Any prior androgen deprivation therapy (ADT) scheme 2 years before recruitment. - Any prior testosterone replacement therapy scheme 2 years before recruitment.
  • Previous intermittent ADT schemes.
  • Prior testicular excision surgery.
  • Absence or testicular atrophy from any cause.
  • Whenever further prospective clinical follow-up is not possible or patient do not accept follow-up in the context of this study.

Trial locations and contacts

3 sites in 1 country.

Ignacio Puche Sanz contact

0034 958 023 158

naho.puchesanz@gmail.com

Soraya Santana contact

0034 958 023 158

ssantana@fibao.es

Spain3 sites

  • Hospital Universitario Reina Sofía

    Córdoba, Andalusia

  • Hospital Universitario Virgen de las Nieves

    Granada, Andalusia

  • Hospital Universitario Virgen del Rocio

    Seville

Other trials in Spain

About this study

Official title: Baseline Testosterone as a Prognostic and/or Predictive Biomarker in Metastatic Hormone Sensitive Prostate Cancer

Despite large amounts of basic-science data supporting a role for androgens in PCa pathogenesis, there are conflicting clinical data on the role of endogenous testosterone in human de novo PCa pathogenesis. The investigators hypothesize that lower baseline serum testosterone is significantly associated with worse clinical outcomes in mHSPC patients undergoing continuous medical castration

Read the detailed description

Biological rationale:

The 'androgen hypothesis' asserts that prostate cancer (PCa) development and progression is driven by androgens. There is significant evidence that androgens promote prostate cancer in experimental models. However, there is no clear evidence that elevations in endogenous testosterone levels promote the development of prostate cancer in humans. Indeed, despite large amounts of basic-science data supporting a role for androgens in PCa pathogenesis, there are conflicting clinical data on the role of endogenous testosterone in human PCa pathogenesis de novo. In reviewing the literature involving PCa development in PCa naive patients, there are studies implicating elevated testosterone, studies implicating lower testosterone, and studies with no association of testosterone and PCa risk.

A recent review in 2015 delved into the controversial role of androgens and prostate cancer and explains the different theories about the ambiguous action of testosterone on the prostate. In 2012, a research proposed the nonlinear U-shaped behaviour or time dependency theory, which postulates that the endocrine biology of the prostate tissue depends on exposure time at a given androgen concentration, which "relies on the fluctuation of the levels of circulating sex steroids during the lifespan of the individual". Another model is the saturation model based on the observations that prostate tissue is extremely sensitive to changes in serum testosterone at low concentrations. This model suggests that there is a nonprotective effect of low testosterone against PCa but tissue becomes indifferent to changes when increasing androgen concentration reach a limit (saturation point), beyond which no further androgen-driven changes are observed. Anyway, the lack of a satisfying model to explain the relationship between androgens and PCa is simply the consequence of insufficient knowledge of the real intrinsic physiopathology of this disease.

Clinical rationale:

Approximately 15% of mHSPC patients primarily fail to respond to ADT. A recent consensus statement on circulating biomarkers for advanced prostate cancer highlighted the urgent need for prospective trials to clinically qualify circulating biomarkers, the greatest need being metastatic PCa. On the other hand, a very recent paper analysed baseline testosterone in hormone-naïve advanced PCa patients undergoing continuous medical castration and selected from 2 large Phase III RCTs. It demonstrated that lower baseline serum testosterone was significantly associated with worse survival end-points and warrants further prospective research in this scenario.

In this era of complex and expensive next-generation markers, this simple, cheap, and well-known biomarker may still have something to say in PCa.

Being tested
Testosterone levels
Keywords
Testosterone, biomarker

What participants receive

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

  • Testosterone levelsDiagnostic test

    Blood sample to determine testosterone levels

What is being measured

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

  1. Early treatment failure

    Proportion of patients with PSA progression or death from PCa within 12 months after initiation of treatment.

    Measured: 1 year

  2. PSA response

    Lowest PSA (nadir) reached after initiation of treatment

    Measured: 6 months

Secondary outcomes (4)

  1. Testosterone response.

    %percent of decrease in testosterone levels at the moment of PSA nadir.

    Measured: 6 months

  2. Biochemical progression-free survival (bPFS)

    PSA progression: 2 consecutive increase at least 50% or 5 ng/mL or more above PSA nadir on 2 consecutive measurements at least 2 weeks apart.

    Measured: 1 year

  3. Radiologic progression-free survival (rPFS)

    Assessed by PCWG3 progression criteria on nodal, visceral and bone disease.

    Measured: 1 year

  4. Time to CRPC

    Time (months) from treatment initiation to the development of a CRPC status.

    Measured: 1 year

Timeline

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

  1. First posted7 Sep 2022
  2. Study start1 Jan 2023 (estimated)
  3. Primary completion1 Jan 2025 (estimated)
  4. Study completion1 Jan 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
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05530395
Sponsor's protocol ID
BATEMARK-YAUPCa-21
Status last verified
Sep 2022
First submitted
2 Sep 2022
Last updated
14 Sep 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Michaud JE, Billups KL, Partin AW. Testosterone and prostate cancer: an evidence-based review of pathogenesis and oncologic risk. Ther Adv Urol. 2015 Dec;7(6):378-87. doi: 10.1177/1756287215597633.

    PubMed 26622322

  • Pierorazio PM, Ferrucci L, Kettermann A, Longo DL, Metter EJ, Carter HB. Serum testosterone is associated with aggressive prostate cancer in older men: results from the Baltimore Longitudinal Study of Aging. BJU Int. 2010 Mar;105(6):824-9. doi: 10.1111/j.1464-410X.2009.08853.x. Epub 2009 Sep 14.

    PubMed 19751256

  • Yano M, Imamoto T, Suzuki H, Fukasawa S, Kojima S, Komiya A, Naya Y, Ichikawa T. The clinical potential of pretreatment serum testosterone level to improve the efficiency of prostate cancer screening. Eur Urol. 2007 Feb;51(2):375-80. doi: 10.1016/j.eururo.2006.08.047. Epub 2006 Sep 12.

    PubMed 17005316

  • Rajek NJ. Developing an evening clinical experience for baccalaureate community health nursing students. J Nurs Educ. 1987 May;26(5):197-200. doi: 10.3928/0148-4834-19870501-07.

    PubMed 3035140

Questions about this trial

What is this clinical trial studying?

An observational study of Prostate Cancer Metastatic, run by Ignacio Puche Sanz at 3 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 5 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: status not confirmed, as of the sponsor's last update on 14 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ignacio Puche Sanz (0034 958 023 158, naho.puchesanz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Early treatment failure (time frame: 1 year). The study lists 2 primary outcomes in all. 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 NCT05530395, which also lists 4 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 14 Sep 2022.

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