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Metastatic Castration-resistant Prostate CancerPhase 2NCT04586543

Clinical Trial of Selegiline Plus Docetaxel for the Treatment of Metastatic, Castrate-resistant Prostate Adenocarcinoma

A Phase 2 study testing Selegiline and Docetaxel in people with Metastatic Castration-resistant Prostate Cancer and Adenocarcinoma of the Prostate, run by László Mangel at 1 site in Hungary.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

The objective of this clinical study is to evaluate the effectiveness and safety of selegiline plus docetaxel therapy compared to the standard of care - docetaxel therapy - among patients diagnosed with metastatic, castrate-resistant prostate adenocarcinoma. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Selegiline and Docetaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
1 siteHungary
Study dates
18 May 2020to 1 Feb 2025
Phase
Phase 2
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 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18 years or older male patients,
  • Histologically or cytologically confirmed prostate adenocarcinoma
  • Radiologically confirmed metastatic disease,
  • Eligibility to receive oral therapy,
  • Suitable for docetaxel therapy,
  • Patients with castration-resistant prostate carcinoma who eligible to first-line docetaxel therapy or patients with castration-resistant prostate cancer who progressed after second-generation hormone therapy (abiraterone or enzalutamide) with pre-chemotherapy indication and eligible to second-line docetaxel therapy
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  • At least 4 weeks has elapsed between the last antiandrogenic therapy and the inclusion (at least 6 weeks in case of bicalutamide),
  • Planned docetaxel treatment,
  • Eastern Cooperative Oncology Group (ECOG) performance status: ≤ 2,
  • Estimated life expectancy of more than 12 weeks,
  • Adequate analgesic therapy as required;
  • Patients must be able to follow the diet and medical instructions,
  • Use of effective contraception in men of childbearing age,
  • Provision of signed, written information consent

Who cannot join

  • De novo metastatic patients who needs immediate docetaxel therapy;
  • Within 4 weeks prior to randomisation, the patient has received other study medication or failed to recover from any adverse events caused from a previously administered study drug
  • ≥ Grade 2 anticancer therapy-related toxicity (except alopecia),
  • Has had radiotherapy or immunotherapy within 4 weeks prior to treatment,
  • Has had a surgery within 4 weeks prior to treatment,
  • Known or suspected brain metastasis (stable patients with locally treated, asymptomatic brain metastases are not excluded),
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  • Inadequate laboratory function:
  • Absolute neutrophil count <1.5 x 109 /L (1,500 per mm3),
  • Platelet count < 100 x 109 /L (100 000 per mm3),
  • Hemoglobin ≤9.0 g/dL,
  • Serum bilirubin > ULN,
  • AST or ALT
  • i.>2.5 x ULN in patient without liver metastases, ii.>5x ULN in patients with liver metastases.
  • Cardiological status:
  • Uncontrolled hypertension (BP ≥ 150/95 with hypertension treatment)
  • Heart failure (NYHA III or higher),
  • Current or former diagnosis of cardiomyopathy,
  • LVEF ≤ 50%,
  • Atrial fibrillation with >100bpm pulse,
  • Unstable ischemic heart disease (myocardial infarction within 6 months or angina that require more than one nitrate therapy each week).
  • Other uncontrolled or severe systemic disease, active infection, hepatitis B, hepatitis C, HIV,
  • Uncontrolled seizure disorder,
  • Active gastric and duodenal ulcers,
  • Recurrent nausea and vomiting, chronic gastrointestinal disease or intestinal resection that prevents proper absorption,
  • Severe psychiatric illness (including but not limited to manic psychiatric disorder, schizophrenia, bipolar disorder, major depression requiring hospitalization) or social disturbance that limits eligibility for examination,
  • History of other malignancy within the last 5 years (except properly treated basalioma or squamous cell carcinoma of the skin and in situ carcinoma),
  • History of allergic reaction to phenelzine, selegiline or other monoamine oxidase inhibitors (MAOIs) biological agents or similar chemical ingredients,
  • History of allergic reaction to docetaxel therapy or its ingredients,
  • Significant peripheral neuropathy (≥ Grade 2),
  • Selegiline is contra-indicated for concomitant use with:
  • Certain narcotic analgesics (eg. pethidine),
  • Drugs that enhance the sympathetic nervous system,
  • Other MAO inhibitors,
  • Drugs similar to MAO inhibitors,
  • Selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs),
  • Tricyclic antidepressants.

Trial locations and contacts

1 site in 1 country.

László Mangel, Prof. MD contact

+36-72-536-480

mangel.laszlo@pte.hu

Hungary1 site, 1 recruiting

  • University of Pécs, Clinical Centre, Department of Oncotherapy

    Pécs, Baranya, 7624

    László Mangel, Prof. MD, +36-72-536-480, mangel.laszlo@pte.hu

    Recruiting

Other trials in Hungary

About this study

Official title: A Clinical Trial of Selegiline Plus Docetaxel for the Treatment of Metastatic, Castrate-resistant Prostate Adenocarcinoma

The objective of this clinical study is to evaluate the effectiveness and safety of selegiline plus docetaxel therapy compared to the standard of care - docetaxel therapy - among patients diagnosed with metastatic, castrate-resistant prostate adenocarcinoma.

Read the detailed description

Prostate cancer is one of the leading cause of cancer death among males worldwide. The objective of this phase II, randomized, controlled, open label study is to evaluate the effectiveness and safety of MAO-B (Monoamine oxidases-B) inhibitor selegiline plus docetaxel therapy. Patients diagnosed with metastatic, castrate-resistant prostate adenocarcinoma are randomly divided into two groups. One group (control arm) receives docetaxel (75 mg/m2 IV every 3 weeks for maximum of 12 cycles). Another group (experimental arm) receives docetaxel (75 mg/m2 IV every 3 weeks for maximum of 12 cycles) plus selegiline (daily 10 mg tablet). Patients are followed up for 36 months or until the end of the trial, death or withdraw from this study due to other reasons. The primary endpoint of this study is the proportion of patients without progression at month 9. The secondary endpoint is proportion of patients without progression at month 12/18, progression-free survival, overall survival, duration of PSA response, radiological response rate, PSA response rate, health-related quality of life and safety.

Being tested
Selegiline, Docetaxel
Keywords
selegiline, hormone-refractory prostate cancer

What participants receive

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

  • SelegilineDrug

    10 mg selegiline tablet per day

  • DocetaxelDrug

    75mg/m2 docetaxel infusion every 3 weeks for maximum of 12 cycles

Study groups in NCT04586543
Study groupRoleWhat they receive
Selegiline+ DocetaxelExperimentalSelegiline and plus Docetaxel
Receives: Drug: Selegiline; Drug: Docetaxel
DocetaxelActive comparatorDocetaxel
Receives: Drug: Docetaxel

What is being measured

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

  1. Proportion of patients without progression at month 9

    Proportion of patients without progression at month 9. Progression can be identified by clinical symptoms, PSA levels, or radiographic imaging as follows, based on PCWG2 criteria:

    1. Progression based on clinical symptoms:
    2. Decline in ECOG performance status (≥ grade 3),
    3. Initiation of newly adjusted chronic opioid analgesic therapy, which may be, i.Use of oral opioid for at least 3 weeks ii.Use of parenteral opioid for at least 7 days c.Necessity to initiate alternative cytotoxic chemotherapy or other active systemic oncology treatment d.Immediate need for radiation or surgical intervention to treat tumor progression OR
    4. PSA progression: Date at which the PSA level is increased by at least 25% relative to nadir and at least 2 ng / mL absolute increase compared to the nadir. Values are confirmed 4-6 weeks later by a test. OR
    5. Radiological
    6. Progression by RECIST 1.1.
    7. Bone scan progression: A total of ≥ 2 new lesion compared to baseline

    Measured: 12 months

Secondary outcomes (8)

  1. Proportion of patients without progression at month 12

    Measured: 15 months

  2. Proportion of patients without progression at month 18

    Measured: 21 months

  3. Progression-free survival (biochemical, clinical, radiological

    Measured: 5 years

  4. Overall survival

    Measured: 5 years

  5. Duration of PSA response

    Measured: 5 years

  6. Radiological Response Rate

    Measured: 5 years

  7. PSA Response Rate

    Measured: 5 years

  8. Health-Related Quality of Life

    Measured: 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 posted14 Oct 2020
  2. Study start18 May 2020
  3. Primary completion1 Feb 2025 (estimated)
  4. Study completion1 Feb 2025 (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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
110 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04586543
Sponsor's protocol ID
MAO201901
Other IDs
2019-002685-12, 2019
Status last verified
Oct 2020
First submitted
30 Sep 2020
Last updated
14 Oct 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Steib A, Pohoczky K, Toth N, Kormos V, Kun J, Kalai T, Mangel L, Matyus P, Helyes Z. The MAO-B Inhibitor Selegiline Reduces the Viability of Different Prostate Cancer Cell Lines and Enhances the Effects of Anti-Androgen and Cytostatic Agents. Pharmacol Res Perspect. 2025 Oct;13(5):e70173. doi: 10.1002/prp2.70173.

    PubMed 40932155

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Selegiline and Docetaxel in people with Metastatic Castration-resistant Prostate Cancer and Adenocarcinoma of the Prostate, run by László Mangel at 1 site in Hungary.

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 14 inclusion and 36 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 Oct 2020. 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 Hungary. 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?

Results are not available in the source record.

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

Contact László Mangel, Prof. MD (+36-72-536-480, mangel.laszlo@pte.hu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients without progression at month 9 (time frame: 12 months). 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 NCT04586543, which also lists 1 linked publication.

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 Oct 2020.

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