Prostate CancerPhase 1NCT01187485
A Randomized Study of Testosterone Replacement in Patients With Low Risk Hormone Refractory Prostate Cancer
A Phase 1 study testing Androderm® 2.5mg, Androderm® 5.0mg and Androderm® 7.5mg in people with Prostate Cancer, run by University of Chicago at 1 site in United States.
Trial summary
The purpose of this study is to see how safe Androderm® (the study drug) is at three different doses in subjects with early hormone refractory prostate cancer. In addition, information about hormonal levels and the effects of testosterone on quality of life including sexual functioning and muscle strength will be… 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?
- Androderm® 2.5mg, Androderm® 5.0mg and Androderm® 7.5mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2004to Feb 2009
- Phase
- 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
- Patient has a histologically documented diagnosis of prostate adenocarcinoma (PCa) not amenable to curative treatment with surgery or radiation treatment.
- Patient was surgically or pharmacologically castrated at least 6 months prior to randomization. Castration must be verified by a screening testosterone value of <30 ng/dL. Any patient pharmacologically castrated must be maintained on androgen suppression therapy for the duration of the study.
- Patient must have had a previous trial of anti-androgen therapy.
- Patients must have a documented anti-androgen withdrawal period prior to randomization: flutamide requires a minimum 4 weeks withdrawal, and nilutamide and bicalutamide require a minimum 6 weeks withdrawal.
- Patient must meet one of the following PSA criteria:
- A 50% rise in PSA values within a minimum rise to at least 3.0 ng/mL, within 6 months prior to randomization, OR
Show all 19Show fewer
- A rising PSA defined as two sequential increases in PSA values. The following data are required: an initial value (#1) followed by a PSA value demonstrating an increase (#2). The increase must be confirmed by another rise in PSA (#3) (3>2>1). There must be at least 2 weeks between each qualifying PSA value and the absolute PSA value at enrollment must be at least 3.0 ng/ml.
- At the time of screening the patient must have no evidence of visceral organ-confined metastatic disease OR the presence of minimal bone metastases only without evidence of visceral organ-confined metastatic disease.
- The absence of visceral organ-confined metastatic disease is defined as:
- No organ-confined soft tissue metastases (e.g. lung, liver, etc.) as verified by chest/abdomen/pelvic CT scan.
- The presence of pathologically enlarged lymph nodes will not exclude subjects from the study and will not be included in the definition of visceral organ-confined metastatic disease.
- The presence of minimal bone metastases is defined as <1.4% by Bone Scan Index criteria (see section 9).
- ECOG performance status <2 (Karnofsky >70%, see Appendix A).
- Age >18 years. Because no dosing or adverse event data are currently available on the use of Androderm® in the context of androgen ablation in patients <18 years of age, children are excluded from this study but will be eligible for future pediatric phase 1 single-agent trials.
- Patients must have normal hepatic and renal function as defined below:
- total bilirubin within normal institutional limits
- AST(SGOT)/ALT(SGPT) <1.5 X institutional upper limit of normal
- Patient has had no other active malignancies with the exception of non-melanoma skin cancer.
- Patient must possess the ability to understand and be willing to sign a written informed consent document.
Who cannot join
- Patients with a history of any previous cytotoxic therapy or radionuclide therapy (such as rhenium, strontium, or samarium).
- Patients may not be receiving any other investigational agents.
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Patients with evidence of visceral organ-confined metastases other than minimal bone metastases (as defined by <1.4% Bone Scan Index, see section 9) and/or pathologically enlarged lymph nodes will be excluded.
- Patients with local recurrences who are candidates for local salvage therapy (e.g. surgery, radiation, brachytherapy, cryotherapy) will be excluded.
- Patients with significant pulmonary disease who have received chronic or pulse steroid therapy within the last 3 months prior to randomization will be excluded. Steroid therapy for non-pulmonary, non-oncologic conditions are allowed if the patient has been on a chronic, steady-dose regimen for a minimum of 2 months prior to randomization.
- Patients with known skin allergies to polyester, alcohol, aluminum, or silicone.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Phase I Study of Testosterone Replacement in Patients With Low Risk Hormone Refractory Prostate Cancer
The purpose of this study is to see how safe Androderm® (the study drug) is at three different doses in subjects with early hormone refractory prostate cancer. In addition, information about hormonal levels and the effects of testosterone on quality of life including sexual functioning and muscle strength will be collected.
Read the detailed description
Most hormone-refractory disease is currently defined by rising PSA following androgen ablation and an antiandrogen. These patients are typically asymptomatic and have minimal or no radiologically evident disease by standard bone and CT scans. Therapeutic options are limited, with 3rd line hormonal treatments generally providing only brief durations of benefit in a small minority of patients. Chemotherapy is effective, but the role of this somewhat toxic approach in the asymptomatic patient is debatable. In addition, patients suffer from the long-term side effects of androgen ablation such as muscle wasting, decreased strength, decreased sexual functioning, and impaired cognition. If the hypothesis that androgen replacement can inhibit cancer growth in androgen insensitive patients is correct, such treatment would not only delay disease progression but could also improve quality of life. If the hypothesis is incorrect and androgens actually stimulate growth, the consequences are unlikely to be catastrophic since the selected population has only a minimal disease burden.
- Conditions
- Prostate Cancer
- Being tested
- Androderm® 2.5mg, Androderm® 5.0mg, Androderm® 7.5mg
- Keywords
- Androderm®, Testosterone, refractory, prostate, cancer, Patients with "hormone refractory" prostate cancer will be treated with a daily testosterone patch Androderm® applied every 24 hours to the skin
- Medical subject headings
- Prostatic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Androderm® 2.5mgDrug
Subjects will be asked to replace the study drug patch every 24 hours at night following the written and verbal instructions you will receive. The study drug patch should be placed over a small amount of a steroid cream on the skin to reduce irritation.
Androderm® 5.0mgDrug
Subjects will be asked to replace the study drug patch every 24 hours at night following the written and verbal instructions you will receive. The study drug patch should be placed over a small amount of a steroid cream on the skin to reduce irritation.
Androderm® 7.5mgDrug
Subjects will be asked to replace the study drug patch every 24 hours at night following the written and verbal instructions you will receive. The study drug patch should be placed over a small amount of a steroid cream on the skin to reduce irritation.
| Study group | Role | What they receive |
|---|---|---|
| Androderm® 2.5mg | Experimental | Study subjects will be randomized to one of the study arms: 2.5 mg of Androderm®. Receives: Drug: Androderm® 2.5mg |
| Androderm® 5.0 mg | Experimental | Study subjects will be randomized to one of the study arms: 5.0 mg of Androderm®. Receives: Drug: Androderm® 5.0mg |
| Androderm® 7.5mg | Experimental | Study subjects will be randomized to one of the study arms: 7.5 mg of Androderm®. Receives: Drug: Androderm® 7.5mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Study Objective is to determine the safety of Androderm® 2.5 mg, 5.0 mg, and 7.5 mg in patients with early hormone refractory prostate cancer.
To determine the safety of Androderm® 2.5 mg, 5.0 mg, and 7.5 mg in patients with early hormone refractory prostate cancer.
Measured: 1-4 years
Secondary outcomes (1)
Secondary Study Objectives are to determine the effects of Androderm® 2.5 mg, 5.0 mg, and 7.5 mg on total and free testosterone levels and PSA as well as on QOL, sexual functioning, and muscle strength.
To determine the effects of Androderm® 2.5 mg, 5.0 mg, and 7.5 mg on total and free testosterone levels and PSA. To determine the effects of Androderm® 2.5 mg, 5.0 mg, and 7.5 mg on QOL, sexual functioning, and muscle strength.
Measured: 3-5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2010 (estimated)
- Study startJun 2004
- Primary completionFeb 2008
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Walter M Stadler, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01187485
- Sponsor's protocol ID
- 13183B
- Status last verified
- Nov 2023
- First submitted
- 20 Aug 2010
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase I Study of Testosterone Replacement in Patients With Low Risk Hormone Refractory Prostate Cancer
- ClinicalTrials.gov ID
- NCT01187485
- Acronym / sponsor ID
- 13183B
- Conditions
- Prostate Cancer
- Keywords
- Androderm®, Testosterone, refractory, prostate, cancer, Patients with "hormone refractory" prostate cancer will be treated with a daily testosterone patch Androderm® applied every 24 hours to the skin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Jun 2004
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 24 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to see how safe Androderm® (the study drug) is at three different doses in subjects with early hormone refractory prostate cancer. In addition, information about hormonal levels and the effects of testosterone on quality of life including sexual functioning and muscle strength will be collected.
Detailed description
Most hormone-refractory disease is currently defined by rising PSA following androgen ablation and an antiandrogen. These patients are typically asymptomatic and have minimal or no radiologically evident disease by standard bone and CT scans. Therapeutic options are limited, with 3rd line hormonal treatments generally providing only brief durations of benefit in a small minority of patients. Chemotherapy is effective, but the role of this somewhat toxic approach in the asymptomatic patient is debatable. In addition, patients suffer from the long-term side effects of androgen ablation such as muscle wasting, decreased strength, decreased sexual functioning, and impaired cognition. If the hypothesis that androgen replacement can inhibit cancer growth in androgen insensitive patients is correct, such treatment would not only delay disease progression but could also improve quality of life. If the hypothesis is incorrect and androgens actually stimulate growth, the consequences are unlikely to be catastrophic since the selected population has only a minimal disease burden.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Androderm® 2.5mg | Experimental | Drug: Androderm® 2.5mgStudy subjects will be randomized to one of the study arms: 2.5 mg of Androderm®. |
| Androderm® 5.0 mg | Experimental | Drug: Androderm® 5.0mgStudy subjects will be randomized to one of the study arms: 5.0 mg of Androderm®. |
| Androderm® 7.5mg | Experimental | Drug: Androderm® 7.5mgStudy subjects will be randomized to one of the study arms: 7.5 mg of Androderm®. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Patient has a histologically documented diagnosis of prostate adenocarcinoma (PCa) not amenable to curative treatment with surgery or radiation treatment.
- Patient was surgically or pharmacologically castrated at least 6 months prior to randomization. Castration must be verified by a screening testosterone value of <30 ng/dL. Any patient pharmacologically castrated must be maintained on androgen suppression therapy for the duration of the study.
- Patient must have had a previous trial of anti-androgen therapy.
- Patients must have a documented anti-androgen withdrawal period prior to randomization: flutamide requires a minimum 4 weeks withdrawal, and nilutamide and bicalutamide require a minimum 6 weeks withdrawal.
- Patient must meet one of the following PSA criteria:
Key exclusion criteria (7 listed)
- Patients with a history of any previous cytotoxic therapy or radionuclide therapy (such as rhenium, strontium, or samarium).
- Patients may not be receiving any other investigational agents.
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Patients with evidence of visceral organ-confined metastases other than minimal bone metastases (as defined by <1.4% Bone Scan Index, see section 9) and/or pathologically enlarged lymph nodes will be excluded.
- Patients with local recurrences who are candidates for local salvage therapy (e.g. surgery, radiation, brachytherapy, cryotherapy) will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Androderm® 2.5mgSubjects will be asked to replace the study drug patch every 24 hours at night following the written and verbal instructions you will receive. The study drug patch should be placed over a small amount of a steroid cream on the skin to reduce irritation. | Drug | Androderm® 2.5mg |
| Androderm® 5.0mgSubjects will be asked to replace the study drug patch every 24 hours at night following the written and verbal instructions you will receive. The study drug patch should be placed over a small amount of a steroid cream on the skin to reduce irritation. | Drug | Androderm® 5.0 mg |
| Androderm® 7.5mgSubjects will be asked to replace the study drug patch every 24 hours at night following the written and verbal instructions you will receive. The study drug patch should be placed over a small amount of a steroid cream on the skin to reduce irritation. | Drug | Androderm® 7.5mg |
Primary outcome
Primary Study Objective is to determine the safety of Androderm® 2.5 mg, 5.0 mg, and 7.5 mg in patients with early hormone refractory prostate cancer.
Time frame: 1-4 years
To determine the safety of Androderm® 2.5 mg, 5.0 mg, and 7.5 mg in patients with early hormone refractory prostate cancer.
1 secondary outcome
Secondary Study Objectives are to determine the effects of Androderm® 2.5 mg, 5.0 mg, and 7.5 mg on total and free testosterone levels and PSA as well as on QOL, sexual functioning, and muscle strength.
Time frame: 3-5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Walter M Stadler, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Androderm® 2.5mg, Androderm® 5.0mg and Androderm® 7.5mg in people with Prostate Cancer, run by University of Chicago 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 19 inclusion and 7 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 29 Nov 2023. 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?
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?
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?
Primary Study Objective is to determine the safety of Androderm® 2.5 mg, 5.0 mg, and 7.5 mg in patients with early hormone refractory prostate cancer. (time frame: 1-4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Nov 2023.