Hormone Therapy Break for Metastatic Prostate Cancer

(A-DREAM Trial)

Recruiting at 339 trial locations

Overseen By Atish D. Choudhury, MD, PhD

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: Alliance for Clinical Trials in Oncology

Must be taking: LHRH agonist, ARPI

Must not be taking: Experimental agents

Disqualifiers: Surgical castration, Active second malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 18

79 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial involves taking a break from hormonal medications for prostate cancer if your doctor advises it. This means you might stop taking your current medications temporarily, but it depends on your doctor's guidance.

What data supports the effectiveness of the hormone therapy treatment for metastatic prostate cancer?

Research shows that hormone therapy, including androgen deprivation therapy, is effective for treating metastatic prostate cancer, with 70% to 80% of patients showing positive responses such as reduced tumor size and improved well-being. Combining androgen deprivation therapy with other agents has also been shown to improve outcomes in advanced cases. ^{1 2 3 4 5}

Is hormone therapy for metastatic prostate cancer safe?

Hormone therapy for metastatic prostate cancer, also known as androgen deprivation therapy (ADT), is generally safe but can have several side effects. These include hot flashes, sexual dysfunction, breast enlargement, bone thinning, metabolic changes, mood changes, and potential heart issues. It's important to discuss these with your doctor to manage them effectively. ^{4 6 7 8 9}

How is hormone therapy for metastatic prostate cancer different from other treatments?

Hormone therapy for metastatic prostate cancer, also known as androgen deprivation therapy, is unique because it can be administered either surgically or medically, primarily using drugs that affect hormone levels. Unlike other treatments, it can be given intermittently, which may offer benefits without reducing effectiveness, and it is often combined with chemotherapy for better outcomes. ^{2 4 10 11 12}

What is the purpose of this trial?

This phase II trial examines antiandrogen therapy interruptions in patients with hormone-sensitive prostate cancer that has spread to other places in the body (metastatic) responding exceptionally well to androgen receptor-pathway inhibitor therapy. The usual treatment for patients with metastatic prostate cancer is to receive hormonal medications including a medication to decrease testosterone levels in the body and a potent oral hormonal medication to block growth signals from male hormones (like testosterone) in the cancer cells. Patients whose cancer is responding exceptionally well to this therapy may take a break from these medications according to their doctor's guidance. This trial may help doctors determine if stopping treatment can allow for testosterone recovery.

Research Team

Atish D. Choudhury, MD, PhD

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

This trial is for men with metastatic hormone-sensitive prostate cancer who have responded well to intense antiandrogen therapy. They must not have liver or brain metastases, should be on continuous testosterone suppression for 18-24 months, and treated with ARPIs like abiraterone or enzalutamide for at least a year. Men can't join if they're very sick (ECOG 0-2), have high PSA levels, are hypogonadal before treatment, or had surgical castration.

Inclusion Criteria

My scans showed cancer spread before starting hormone therapy.

I am on hormone therapy for cancer using specific medications.

Radiographic evidence of disease is not required at the time of enrollment

Exclusion Criteria

I do not have an active second cancer, except for certain skin or superficial bladder cancers.

My PSA level is 5 ng/ml or higher before starting intense hormone therapy.

Testosterone < 50 ng/dl at time of enrollment to A032101

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Interruption

Patients stop both hormonal medications and are monitored for symptoms

18 months

Follow-up every 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

10 years

Every 6 months

Treatment Details

Interventions

• Antiandrogen Therapy

Trial Overview The A-DREAM trial is testing whether patients with advanced prostate cancer can safely take breaks from their hormonal medications after responding exceptionally well to them. It involves stopping the usual drugs that lower testosterone and block male hormones in cancer cells under doctor supervision to see if this allows natural testosterone recovery without worsening the disease.

Participant Groups

Group I: Treatment (discontinue hormonal medication, follow up) Experimental Treatment 4 Interventions

Patients stop both hormonal medications (medication to decrease testosterone levels in the body and potent oral hormonal medication to block growth signals from male hormones in the cancer cells). Patients are then followed every 12 months for symptoms. Patients with an increase in PSA level to greater than or equal to 5 ng/ml, changes on imaging studies suggesting that their cancer is growing back, or symptoms that the doctor thinks is related to their cancer growing back, resume both hormonal treatments.

Antiandrogen Therapy is already approved in United States, European Union for the following indications:

Approved in United States as Antiandrogen Therapy for:

• Prostate cancer

Approved in European Union as Antiandrogen Therapy for:

• Prostate cancer

Who Is Running the Clinical Trial?

Alliance for Clinical Trials in Oncology

Lead Sponsor

Trials

521

Recruited

224,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

Androgen deprivation therapy (ADT) is effective for managing metastatic or recurrent prostate cancer but can lead to significant side effects, including changes in body composition, increased fracture risk, and insulin resistance.

Recent studies suggest that denosumab and toremifene citrate can help reduce fracture risk in men undergoing ADT, highlighting the importance of managing these adverse effects to improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Androgen deprivation therapy in prostate cancer: anticipated side-effects and their management. Kim, HS., Freedland, SJ.[2015]

References

1. Australia pubmed.ncbi.nlm.nih.gov

Pulmonary metastasis secondary to abiraterone-resistant prostate cancer with homozygous deletions of BRCA2: First Japanese case. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Abiraterone acetate in combination with prednisone in the treatment of prostate cancer: safety and efficacy. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Targeting Metastatic Hormone Sensitive Prostate Cancer: Chemohormonal Therapy and New Combinatorial Approaches. [2019]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Androgen Deprivation Therapy in Prostate Cancer - Current Status in M1 Patients. [2015]

5. United States pubmed.ncbi.nlm.nih.gov

Hormonal therapy in prostatic carcinoma. [2004]

6. United States pubmed.ncbi.nlm.nih.gov

Androgen deprivation therapy in prostate cancer: anticipated side-effects and their management. [2015]

7. United States pubmed.ncbi.nlm.nih.gov

Complications of Androgen Deprivation Therapy in Men With Prostate Cancer. [2018]

8. England pubmed.ncbi.nlm.nih.gov

A systematic review and meta-analysis on overall survival, failure-free survival and safety outcomes in patients with metastatic hormone-sensitive prostate cancer treated with new anti-androgens. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

The current state of hormonal therapy for prostate cancer. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

How is androgen-dependent metastatic prostate cancer best treated? [2019]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Differential Impact of Gonadotropin-releasing Hormone Antagonist Versus Agonist on Clinical Safety and Oncologic Outcomes on Patients with Metastatic Prostate Cancer: A Meta-analysis of Randomized Controlled Trials. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

Management of Hormone-Sensitive and Hormone-Refractory Metastatic Prostate Cancer. [2019]