CLINICAL TRIAL

High dose testosterone for Prostate Cancer

Metastatic
Recruiting · 18+ · Male · Decatur, GA

This study is evaluating whether DNA repair deficiency predicts for a high likelihood of responding to intermittent high dose testosterone.

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About the trial for Prostate Cancer

Eligible Conditions
Prostatic Neoplasms · refractory, metastatic hormone-refractory Prostate cancer

Treatment Groups

This trial involves 3 different treatments. High Dose Testosterone is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Experimental Group 1
High dose testosterone
DRUG
Experimental Group 2
High dose testosterone
DRUG
Experimental Group 3
High dose testosterone
DRUG

Eligibility

This trial is for male patients aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Histologically or cytologically confirmed adenocarcinoma of the prostate
Signed informed consent form (ICF) providing agreement to adhere to the dosing schedule, report for all trial visits and authorization, use and release of health and research trial information
Male age > 18 years
Ongoing gonadal androgen deprivation therapy with gonadotropin-releasing hormone (GnRH) analogues, antagonists or orchiectomy. Patients who have not had an orchiectomy must be maintained on effective GnRH analogue/antagonist therapy
PSA level of at least 2 ng/ml that has risen on at least 2 successive occasions at least 1 week apart.
Evaluable disease progression by modified RECIST 1.1 (Response Evaluation Criteria in Solid Tumors)
Progression of metastatic bone disease on bone scan with > 2 new lesions
Presence of metastatic disease on bone or CT scan
Patients must have progressed on 1 next-generation AR-signaling inhibitor (e.g. abiraterone, enzalutamide, apalutamide, darolutamide, etc.).
Asymptomatic or minimal cancer related symptoms
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 12 weeks
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 weeks
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 12 weeks.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether High dose testosterone will improve 1 primary outcome in patients with Prostate Cancer. Measurement will happen over the course of 12 weeks.

PSA response
12 WEEKS
PSA response as measured by a 50% decline from baseline maintained for 12 weeks
12 WEEKS

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How does high dose testosterone work?

High dose testosterone replacement therapy results in increased circulating IGF-1 and IGFBP-3 levels. Results from a recent paper support a role for androgens in the regulation of the insulin-like growth factor system in human males.

Anonymous Patient Answer

Is high dose testosterone typically used in combination with any other treatments?

In our study we observed that higher dosages of T were administered to some of our patients than was reported in the literature. This dosage pattern was mainly related to age and comorbidities.

Anonymous Patient Answer

What is the average age someone gets prostate cancer?

The average age at diagnosis was 68 years, with a large variation between different regions in the USA. The average age of diagnosis differed significantly according to race (65 yr in White Americans vs 69 yr in Black American), socioeconomic class (64 yr in low-socioeconomic status vs 71 yr in high-socioeconomic status), and geographic region (69 yr in Midland, Michigan). These data imply that prostate cancer incidence varies significantly across racial, socioeconomic, geographic regions, and even among specific areas within these regions.

Anonymous Patient Answer

What is high dose testosterone?

High dose testosterone therapy should be considered based on the risks of testosterone therapy and aging. Older men who received higher doses showed an increased rates of fatal and non-fatal cardiovascular events compared to those treated with lower doses. Risk factors for cardiovascular mortality were statistically significant only among men receiving high doses of testosterone.

Anonymous Patient Answer

What does high dose testosterone usually treat?

High doses of testosterone increase prostate volume, but they do not affect PSA, DRE, or MPS in men with a normal prostate. There was no difference in prostate volume between the groups. Recent findings suggest that high dosage of testosterone should be reconsidered before using it routinely for treatment.

Anonymous Patient Answer

What is the primary cause of prostate cancer?

Although it was hypothesized that genetic factors account for about 20% of prostate cancer, we found that the HER2/neu gene is not involved in prostate cancer development. Rather, other genes are more likely to be responsible for prostate cancer.

Anonymous Patient Answer

Does prostate cancer run in families?

Recent findings suggest that there are multiple genetic predispositions for familial PCa. This finding underlines the need for prospective studies that will identify genes and/or environmental conditions that contribute to familial PCa.

Anonymous Patient Answer

How serious can prostate cancer be?

The mortality rate for PCa was not significantly different between whites and blacks, but Blacks displayed more aggressive features, including a higher prevalence of lymph node metastasis. These data suggest that Blacks are at high risk for treatment failure following surgery, because of poorer prognosis factors when compared with Whites.

Anonymous Patient Answer

What is prostate cancer?

Although the understanding of PCa biology remains incomplete, it is clear that PCa is a heterogeneous group of different diseases, including clinically indolent yet biologically aggressive forms of prostate cancer.

Anonymous Patient Answer

Have there been other clinical trials involving high dose testosterone?

Neither the biological nor the clinical responses were superior to those obtained using low dose estrogen alone. In our experience, high dose testosterone, either alone or combined with estrogens, seems to be less effective than low doses in achieving durable biochemical remission. This effect is probably related to the fact that only a small percentage of the patients showed a complete response to treatment.

Anonymous Patient Answer

How quickly does prostate cancer spread?

In this population-based study of [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer), we found no evidence that prostate cancer was spreading faster than any other type of cancer. Thus, while prostate cancer is an aggressive disease, it appears to be just as likely to spread quickly as other forms of cancer.

Anonymous Patient Answer
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