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Prostate CancerEarly Phase 1NCT03358563

Pilot Trial of Chemohormonal Therapy Followed by Prostatectomy in High Risk Prostate Cancer

A Early Phase 1 study testing Docetaxel, Degarelix and Bicalutamide in people with Prostate Cancer, run by University of Wisconsin, Madison at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a pilot multimodality treatment approach trial with androgen deprivation therapy in combination with docetaxel chemotherapy followed by radical prostatectomy in patients with newly diagnosed high-risk and oligometastatic prostate cancer. 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?
Docetaxel, Degarelix and Bicalutamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
17 Jan 2018to 2 Sep 2022
Phase
Early Phase 1
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

  • Histologically confirmed adenocarcinoma of the prostate without signet cell or small cell features.
  • High risk prostate cancer defined as extracapsular extension (cT3a) or seminal vesicle involvement (cT3b) or invasion of adjacent structures (cT4), serum PSA greater than 20 ng/mL or Gleason score of 8 to 10 and/or regional lymph node or
  • Oligometastatic disease defined as disseminated metastases beyond regional lymph nodes that meet the following criteria:
  • No visceral metastases
  • Less than four bony metastases.
  • Ability to comply with all study procedures and willingness to remain supine for 120 minutes during imaging.
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  • Patients must be informed of the experimental nature of the study and its potential risks, and must sign an Institutional Review Board (IRB)-approved written informed consent form indicating such an understanding.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at screening.
  • Patients must be considered candidates for prostatectomy as per standard of care.
  • Adequate hematologic and renal function as evidenced by the following within 4 weeks of day 1:
  • ANC greater than or equal to 1500/mm3
  • Hemoglobin (HgB) greater than or equal to 10.0 gr/dL independent of transfusion
  • Platelets greater than or equal to 100,000/mm3
  • Creatinine less than or equal to 2.0 mg/dL
  • Total bilirubin less than or equal to Upper Limit of Normal (ULN)
  • Estimated life expectancy of greater than or equal to 12 months at screening.
  • Throughout the study, patient and his female partner who is of childbearing potential must use 2 acceptable methods of birth control (1 of which must include a condom as a barrier method of contraception) from screening through 3 months after last dose of study drug. Two acceptable methods of birth control thus include the following:
  • A condom (barrier method of contraception) AND One of the following is required:
  • Established and ongoing use of oral, injected, or implanted hormonal method of contraception by the female partner
  • Placement of an intrauterine device or intrauterine system by the female partner
  • Additional barrier method: Contraceptive sponge or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository by the female partner
  • Tubal ligation in the female partner performed at least 6 months before screening
  • Vasectomy or other procedure resulting in infertility (eg, bilateral orchiectomy), performed at least 6 months before screening
  • While receiving chemotherapy, the patient must use a condom if having sex with a pregnant woman.
  • Must agree not to donate sperm from first dose of study drug through 3 months after the last dose of study drug.

Who cannot join

  • Prior treatment for prostate cancer, including ADT, orchiectomy, antiandrogens, ketoconazole, abiraterone acetate or enzalutamide.
  • Prior radiation to the prostate.
  • Use of other investigational agent for prostate cancer.
  • No active secondary malignancy
  • Chronic liver disease or abnormal liver function:
  • Total bilirubin greater than ULN (NOTE: in subjects with Gilbert's syndrome, if total bilirubin is greater than ULN, measure direct and indirect bilirubin and if direct bilirubin is within normal range, subject may be eligible) or
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  • Alanine (ALT) or aspartate (AST) aminotransferase greater than 2.0 x ULN or
  • ALT or aspartate AST greater than 1.5 x ULN concomitant with alkaline phosphatase greater than 2.5 x ULN.
  • Peripheral neuropathy grade greater than 1.
  • Active cardiac disease defined as active angina, symptomatic congestive heart failure, or myocardial infarction within the previous 6 months.
  • Major surgery within 4 weeks before screening.
  • Patients with known psychological or sociological conditions, addictive disorders or family problems, which would preclude compliance with the protocol.
  • Herbal supplements that have been shown to modulate testosterone or androgen signaling (e.g. Saw Palmetto) are not allowed while on study.
  • Subjects may not be enrolled concurrently on other treatment studies. Any concurrent disease, infection, or comorbid condition that interferes with the ability of the patient to participate in the trial; places the patient at undue risk; or complicates the interpretation of the data, in the opinion of the investigator or medical monitor.
  • Subjects who will be receiving Ferumoxytol MRI tracer must:
  • Not have any known hypersensitivity to Feraheme or any of its components
  • Must not have a history of allergic reaction to any intravenous iron product.
  • Must not have a known iron overload (based on medical history)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Wisconsin Carbone Cancer Center

    Madison, Wisconsin, 53792

Other trials in United States

About this study

Official title: Pilot Neoadjuvant Trial of Chemohormonal Therapy Followed by Prostatectomy in Patients With High Risk or Oligometastatic Prostate Cancer

This is a pilot multimodality treatment approach trial with androgen deprivation therapy in combination with docetaxel chemotherapy followed by radical prostatectomy in patients with newly diagnosed high-risk and oligometastatic prostate cancer. This study aims to evaluate the rates of complete pathologic response (pCR) at the time of prostatectomy as well as PSA response, time to PSA recurrence and safety and toxicity of the combination. This study will be heavily embedded with biomarker analyses of the tumor and tumor cells in circulation as well in the bone marrow before and after treatment and will also include imaging analyses using a novel positron emission tomography (PET) imaging technology.

Read the detailed description

Per a protocol amendment approved on 9/5/2019 - two ferumoxytol MRI scans were added for 3 participants, represented here as an additional arm.

Conditions
Prostate Cancer
Being tested
Docetaxel, Degarelix, Bicalutamide, Ferumoxytol-enhanced MRI imaging
Keywords
Prostate Cancer, Prostatectomy, Chemohormonal therapy, Androgen deprivation therapy, docetaxel chemotherapy
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • DocetaxelDrug

    Also called docetaxel chemotherapy, taxotere, PR 56976, NSC #628503

    Docetaxel is a commercially marketed product that has been approved by the FDA for the treatment of metastatic prostate cancer. It is also approved for the treatment of other malignant disease, such as locally advanced or metastatic breast cancer that returns after any prior chemotherapy; locally advanced or metastatic non-small cell lung cancer that recurs after prior platinum-based chemotherapy. However, the FDA does not currently approve its use in patients with localized prostate cancer but no evidence of radiographic metastases.

  • DegarelixDrug

    Also called Degarelix acetate

    Degarelix is a leuteinizing hormone-releasing hormone (LHRH) antagonist. Degarelix is administered at an initial dose of 240 mg subcutaneously (2 separate injections of 120mg each totaling 240 mg) two weeks prior to cycle 1 day 's 1 treatment with chemotherapy. The initial dose is followed by a maintenance dose of 80mg administered subcutaneously as a single injection every 28 days at cycle 2 day 1 (+/- 7 days) and cycle 3 day 10 (+/- 7 days)

  • BicalutamideDrug

    Also called Casodex

    The dose for bicalutamide tablets therapy in combination with an LHRH analog is one 50 mg tablet once daily (morning or evening), with or without food. It is recommended that bicalutamide tablets be taken at the same time each day. Treatment with bicalutamide tablets should be started at the same time as treatment with an LHRH analog.

  • Ferumoxytol-enhanced MRI imagingRadiation

    Ferumoxytol-enhanced MRI imaging will evaluate immune micro-environment in the prostate. Three subjects enrolled to the study will undergo the first ferumoxytol-enhanced MRI imaging within 21 days prior to start of hormonal therapy followed by second and final ferumoxytol-enhanced MRI at the conclusion of hormone therapy but prior to their prostatectomy.

Study groups in NCT03358563
Study groupRoleWhat they receive
Degarelix SC + bicalutamide + docetaxelExperimentalDegarelix SC monthly x3 + bicalutamide 50mg orally QD x 14 wks + Docetaxel 75mg/m2 IV q 21 days x 3
Receives: Drug: Docetaxel; Drug: Degarelix; Drug: Bicalutamide
DegarelixSC + bicalutamide + docetaxel + Ferumoxytol enhanced MRIExperimentalDegarelix SC monthly x3 + bicalutamide 50mg orally QD x 14 wks + Docetaxel 75mg/m2 IV q 21 days x 3 + Ferumoxytol enhanced MRI within 21 days prior to start of hormonal therapy and second and final ferumoxytol-enhanced MRI at the conclusion of hormone therapy but prior to their prostatectomy.
Receives: Drug: Docetaxel; Drug: Degarelix; Drug: Bicalutamide; Radiation: Ferumoxytol-enhanced MRI imaging

What is being measured

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

  1. Change in pCR rates

    Evaluate the pathologic complete response (pCR) rates in the primary tumor from patients with newly diagnosed locally advanced or oligometastatic prostate cancer treated with combination androgen deprivation therapy (ADT) and 3 cycles of docetaxel chemotherapy followed by prostatectomy.

    Measured: Up to 6 months

Secondary outcomes (3)

  1. Change in PSA

    Evaluate the percentage of change in prostate-specific antigen (PSA) from baseline (3 months prior to prostatectomy) to week 6 after prostatectomy in patients with newly diagnosed locally advanced or oligometastatic prostate cancer treated with combination ADT and docetaxel as well as the maximum decline in PSA that occurs at any point during treatment.

    Measured: From baseline (3 months prior to prostatectomy) to 4-6 weeks after prostatectomy.

  2. PSA Recurrence

    Rate of patients with PSA recurrence at month 12 after surgery

    Measured: Up to 12 months

  3. Safety and tolerability of combination ADT and docetaxel measured by CTCAE v.4.0

    Evaluate safety and tolerability of the combination of ADT and docetaxel for up to three months following the last dose of docetaxel.

    Measured: Up to 6 months

Timeline

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

  1. First posted30 Nov 2017
  2. Study start17 Jan 2018
  3. Primary completion10 Aug 2021
  4. Study completion2 Sep 2022

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
Early Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03358563
Sponsor's protocol ID
UW17009
Other IDs
2017-0606, A534260, SMPH\MEDICINE\HEM-ONC, NCI-2017-02428, Protocol Version 1/18/2022
Status last verified
Sep 2022
First submitted
13 Oct 2017
Last updated
3 May 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Docetaxel, Degarelix and Bicalutamide in people with Prostate Cancer, run by University of Wisconsin, Madison at 1 site in United States.

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 25 inclusion and 18 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: finished, as of the sponsor's last update on 3 May 2024. 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 United States. 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in pCR rates (time frame: Up to 6 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 NCT03358563.

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 May 2024.

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