Leuprolide acetate for Prostate Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
University of California San Francisco, San Francisco, CA
Prostate Cancer
Leuprolide acetate - Drug
Eligibility
18+
All Sexes
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Study Summary

This study is evaluating whether a combination of radiation therapy and a drug may help treat prostate cancer.

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Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Leuprolide acetate will improve 2 primary outcomes and 3 secondary outcomes in patients with Prostate Cancer. Measurement will happen over the course of Up to 15 months.

Month 15
Change Rate of prostate-specific antigen (PSA) < nadir + 2 ng/mL from first day of treatment to 15 months (Cohort 2)
Up to 15 months
Number of participants with treatment-related adverse events
Progression-free survival (PFS) (Cohort 2)
Rate of testosterone-PSA uncoupling (Cohort 2)
Time to clinical progression (Cohort 2)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

4 Treatment Groups

Cohort 1: Prostate Only Sites (ADT, SBRT, Pembrolizumab)
1 of 4
Cohort 1: Prostate Only Sites (ADT, SBRT, Pembrolizumab, SD-101)
1 of 4
Cohort 2: Prostate and Oligometastatic sites (ADT, SBRT, Pembrolizumab, SD-101)
1 of 4
Cohort 2: Prostate and Oligometastatic sites (ADT, SBRT, Pembrolizumab)
1 of 4
Experimental Treatment

This trial requires 42 total participants across 4 different treatment groups

This trial involves 4 different treatments. Leuprolide Acetate is the primary treatment being studied. Participants will be divided into 4 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Cohort 1: Prostate Only Sites (ADT, SBRT, Pembrolizumab)Three month androgen deprivation therapy (ADT) run-in followed by leuprolide injected intramuscularly every 3 months for 3 doses (or another FDA approved gonadotropin-releasing hormone agent for 9 months) + abiraterone by mouth daily with prednisone by mouth daily (or equivalent medication per local standard practice) for 9 months starting on Day 1. Pembrolizumab: Given IV every 21 days for up to 13 doses Radiotherapy: Given every other day over 10-14 days delivered to the whole prostate gland via stereotactic body radiation therapy (SBRT) starting 1-2 weeks after marker placement.
Cohort 1: Prostate Only Sites (ADT, SBRT, Pembrolizumab, SD-101)Three month androgen deprivation therapy (ADT) run-in followed by leuprolide injected intramuscularly every 3 months for 3 doses (or another FDA approved gonadotropin-releasing hormone agent for 9 months) + abiraterone by mouth daily with prednisone by mouth daily (or equivalent medication per local standard practice) for 9 months starting on Day 1. TLR9 agonist SD-101: Injected into the dominant prostatic tumor lesion at time of fiducial marker placement (1-5weeks prior to Cycle 1 Day 1) and 1-3 weeks after Cycle 1 Day 1 Pembrolizumab: Given IV every 21 days for up to 13 doses Radiotherapy: Given every other day over 10-14 days delivered to the whole prostate gland via stereotactic body radiation therapy (SBRT) starting 1-2 weeks after marker placement.
Cohort 2: Prostate and Oligometastatic sites (ADT, SBRT, Pembrolizumab, SD-101)Three month androgen deprivation therapy (ADT) run-in followed by leuprolide injected intramuscularly every 3 months for 3 doses (or another FDA approved gonadotropin-releasing hormone agent for 9 months) + abiraterone by mouth daily with prednisone by mouth daily (or equivalent medication per local standard practice) for 9 months starting on Day 1. TLR9 agonist SD-101: Injected into the dominant prostatic tumor lesion at time of fiducial marker placement (1-5weeks prior to Cycle 1 Day 1) and 1-3 weeks after Cycle 1 Day 1 Pembrolizumab: Given IV every 21 days for up to 13 doses Radiotherapy: Given every other day over 10-14 days delivered to the whole prostate gland and oligometastatic sites via stereotactic body radiation therapy (SBRT) starting 1-2 weeks after marker placement.
Cohort 2: Prostate and Oligometastatic sites (ADT, SBRT, Pembrolizumab)Three month androgen deprivation therapy (ADT) run-in followed by leuprolide injected intramuscularly every 3 months for 3 doses (or another FDA approved gonadotropin-releasing hormone agent for 9 months) + abiraterone by mouth daily with prednisone by mouth daily (or equivalent medication per local standard practice) for 9 months starting on Day 1. Pembrolizumab: Given IV every 21 days for up to 13 doses Radiotherapy: Given every other day over 10-14 days delivered to the whole prostate gland and oligometastatic sites via stereotactic body radiation therapy (SBRT) starting 1-2 weeks after marker placement.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
Stereotactic Body Radiation Therapy
2016
Completed Phase 2
~590
SD-101
2014
Completed Phase 2
~90
Prednisone
FDA approved
Abiraterone
FDA approved
Leuprolide
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: start of treatment and 15 months (approx. 15 months total)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly start of treatment and 15 months (approx. 15 months total) for reporting.

Closest Location

University of California San Francisco - San Francisco, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received newly diagnosed for Prostate Cancer. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Distant metastatic lymph node disease. A lymph node ≥1 cm in shortest dimension will be noted as involved with disease. Distant metastatic lymph nodes will be determined as any lymph nodes outside the confines of the true pelvis. For patients undergoing PSMA PET, only PSMA avid lesions that are consistent with metastasis will be counted as a site of metastasis.
Any other soft tissue lesion deemed by the physician to be consistent with distant metastatic disease. For patients undergoing PSMA PET, only PSMA avid lesions that have a CT or MRI correlate consistent with metastasis will be counted as a site of metastasis.
Note: Radiographic imaging performed as standard of care prior to obtaining informed consent and within 60 days of initiating study treatment may be used to assess oligometastatic disease during screening, rather than repeating scans. For patients who have started on ADT, they must have had imaging prior to initiation of hormonal therapy
Treatment naïve, defined as less than 2 months of standard of care ADT (e.g. GnRH agonist or antagonist with or without antiandrogen, including abiraterone) for metastatic hormone-sensitive prostate cancer prior to enrollment (at the time of consent)
Be willing and able to provide written informed consent/assent for the trial.
Be >=18 years of age on day of signing informed consent.
Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
Histologically documented adenocarcinoma of the prostate
Bone metastases will be defined by bone imaging. If the patient has technetium bone scan, and/or sodium fluoride (NaF) PET performed, either study may be used for documenting metastases; both scans do not need to show the number of metastases required for study entry. For patients undergoing PSMA PET, only PSMA avid lesions that are consistent with metastasis will be counted as a site of metastasis.
No prior chemotherapy for prostate cancer

Patient Q&A Section

Can prostate cancer be cured?

"Although the cure rate is low, patients can expect to be cured of prostate cancer, if they can be recognized early. However, many prostate cancer patients are diagnosed at later stages. If prostate cancer is diagnosed late it more often results in death, compared to early diagnosed patients. On the basis of these results, the cure rate is very small for prostate cancer, but it shows a large potential of improvement through early diagnosis, and therefore high cure rates could be reached with further optimization of screening methods and treatment options." - Anonymous Online Contributor

Unverified Answer

How many people get prostate cancer a year in the United States?

"There have been significant increases in prostate cancer diagnoses in the United States, although the number of people diagnosed is relatively low compared with other European countries. A rising trend, which might be attributed to improved detection, has been evident in the past 10 years." - Anonymous Online Contributor

Unverified Answer

What is prostate cancer?

"The symptoms of [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) are often not present until a late stage. Symptoms are more important determinants of quality of life than cancer related factors.\n" - Anonymous Online Contributor

Unverified Answer

What are common treatments for prostate cancer?

"The treatments for [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) are largely dependent on the characteristics of cancer: its severity and the presence of metastasis (trend of less aggressive and better prognosis cancers, respectively). They usually include surgery, radiation therapy or targeted therapy. The most common hormonal therapy, as well as some immunotherapy and chemotherapy. Other solutions include surgical removal of the prostate and the use of a combination of androgen deprivation therapy and chemotherapy." - Anonymous Online Contributor

Unverified Answer

What causes prostate cancer?

"Although most cancers are not caused by a single factor, some cancers have an identifiable set of causative factors. Understanding these relationships can help prevent or reduce the likelihood of developing prostate cancer. And with the appropriate amount and duration of exposure to the causative agent, it can also prevent or reduce the risk of developing prostate cancer. These factors include lifestyle, genetic and environmental factors, including diet, hormones such as estrogens and growth factors such as testosterone. The role of chemical, occupational, or environmental toxins or irradiation in prostate cancer is unclear and needs further investigation." - Anonymous Online Contributor

Unverified Answer

What are the signs of prostate cancer?

"Testicular masses on ultrasound are the most common ultrasound findings of prostate cancer in the absence of symptoms. In those with symptoms, digital rectal examination may uncover palpable masses." - Anonymous Online Contributor

Unverified Answer

What are the chances of developing prostate cancer?

"The number of men with at least one risk factor increases very quickly from age 50 to 60 or 70. Based on data from one epidemiological study the probability of developing prostate cancer for a man at age 70 is 6.3%." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving leuprolide acetate?

"Findings from a recent study from the trial and the publications of this study in regards to the leuprolide acetate preparations, are in concordance with previous publications. Despite the lack of data from the aforementioned publications, in regards to the occurrence of any serious side effects leuprolide acetate might possess, it is unlikely that any other dosage could be more advantageous as a treatment option for prostate cancer than the dosage of the present study. Therefore, the authors conclude that the result of the study is a milestone supporting the indication of leuprolide acetate and underlining the effectiveness of the preparation." - Anonymous Online Contributor

Unverified Answer

How quickly does prostate cancer spread?

"Men who have a Gleason sum of > 8 or who have PSA > 1.0 ng/mL may be at high risk for metastases at presentation. Patients with a Gleason sum of 4, PSA between 0.1 and 1.0 ng/mL, and/or a T(a)/T(b)> 0.5 are candidates for more aggressive management strategies." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of prostate cancer?

"Age, smoking, race, total body testosterone, and a history of prostate disease among men with prostate cancer are associated with the development of an aggressive phenotype. The study suggests that the prostate gland may be the target for initiation or amplification of aggressive behavior in men with prostate cancer, particularly in younger patients who have a history of high serum testosterone. Additional studies are indicated of the impact of testosterone therapy in the genesis of progressive prostate cancers." - Anonymous Online Contributor

Unverified Answer

Has leuprolide acetate proven to be more effective than a placebo?

"Recent findings of this study are of great importance to the urological community, being the results, from both centers, concordant and support the notion that LA is more effective than placebo in the treatment of LUTS as one of its major indications. Moreover, the findings highlight LA as a suitable and effective treatment choice in a cohort of patients, who have never received LA therapy before, but they will soon probably start it. With LA as an important therapeutic option it is crucial to make known, in clinical practice, the evidence in support of its effectiveness." - Anonymous Online Contributor

Unverified Answer

What is the latest research for prostate cancer?

"A large number of new research reports have appeared in both the medical literature and on the web. This is in tandem with an overall increase in the number of prostate cancer cases diagnosed worldwide. In addition to improving the quality of care of patients with prostate cancer, this body of new information promotes the development of improved diagnostic and interventional techniques for this disease, and warrants a need for a greater international collaboration to optimize these advances." - Anonymous Online Contributor

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