Current Clinical Trials

A032101: Testing Interruption of Hormonal Medications in Patients Responding Exceptionally to Therapy for Metastatic Prostate Cancer, (A-DREAM)
  1. Delshad Ahmad, MD
    Delshad Ahmad, MD
  2. for people 18 Years and up (full criteria)
  3. Rancho Mirage, CA
  4. study started November 2022
  5. Delshad Ahmad, MD
  6. Accepting new patients

Description

Summary

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.

Official Title

A032101: A Phase 2 Trial of ADT Interruption in Patients Responding Exceptionally to AR-Pathway Inhibitor in Metastatic Hormone-Sensitive Prostate Cancer (MHSPC): A-DREAM

Detailed Description

PRIMARY OBJECTIVE: I. To determine the proportion of men who experience 18-month treatment-free interval from therapy with eugonadal testosterone (to >= 150 ng/ml) after treatment interruption. SECONDARY OBJECTIVES: I. To determine time to eugonadal testosterone (> 150 ng/dl). II. To determine duration off-treatment. III. To assess changes in quality of life as follows: To assess changes in patient-reported quality of life as assessed by the Functional Assessment of Cancer Therapy- Prostat... more
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PRIMARY OBJECTIVE: I. To determine the proportion of men who experience 18-month treatment-free interval from therapy with eugonadal testosterone (to >= 150 ng/ml) after treatment interruption. SECONDARY OBJECTIVES: I. To determine time to eugonadal testosterone (> 150 ng/dl). II. To determine duration off-treatment. III. To assess changes in quality of life as follows: To assess changes in patient-reported quality of life as assessed by the Functional Assessment of Cancer Therapy- Prostate (FACT-P) total score from baseline to 24 months after treatment interruption. To assess changes in the FACT-P subscales (i.e., physical well-being, social and family well-being, emotional well-being, functional well-being, and prostate cancer subscale) from baseline to 24 months after treatment interruption. To assess changes in the FACT-P total score and subscales (i.e., physical well-being, social and family well-being, emotional well-being, functional well-being, and prostate cancer subscale) from baseline to the remaining post-baseline time points (i.e., 6, 12, and 18 months) after treatment interruption. OUTLINE: 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 prostate specific antigen (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. After completion of study treatment, patients are followed up every 6 months for 10 years from registration or withdrawal from the study or death.

Keywords

Castration-Sensitive Prostate Carcinoma

Eligibility

for people 18 Years and up
Inclusion Criteria: Histologic or clinical diagnosis of metastatic prostate cancer Must have had evidence of metastatic disease by bone scan, or nodal or visceral lesions on computed tomography (CT) or magnetic resonance imaging (MRI) prior to starting on intense antiandrogen therapy (ADT) Radiographic evidence of disease is not required at the time of enrollment No metastases to liver or to brain, as these represent aggressive variant disease biology for which intermittent treatment may not be ... more
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Inclusion Criteria: Histologic or clinical diagnosis of metastatic prostate cancer Must have had evidence of metastatic disease by bone scan, or nodal or visceral lesions on computed tomography (CT) or magnetic resonance imaging (MRI) prior to starting on intense antiandrogen therapy (ADT) Radiographic evidence of disease is not required at the time of enrollment No metastases to liver or to brain, as these represent aggressive variant disease biology for which intermittent treatment may not be favored Must currently be receiving intense ADT for metastatic hormone sensitive prostate cancer (mHSPC) Testosterone suppression (TS) with luteinizing hormone releasing hormone (LHRH)-agonist or LHRH-antagonist AND An approved secondary androgen receptor pathway inhibitor (ARPI) abiraterone, enzalutamide, or apalutamide (or darolutamide if approved for this indication) Must have remained on testosterone suppression for metastatic disease continuously (without treatment breaks) for 540-750 days (approximately 18 to 24 months) from time of first dose of LHRH agonist or antagonist by time of registration. A period of anti-androgen treatment prior to LHRH agonist or antagonist initiation is not included in the 540 - 750 days (approximately 18 to 24 months) Must have received treatment with ARPI for at least 360 days in total by time of A032101 registration. Treatment breaks from ARPI of up to 28 days are permitted (for example peri-procedural or for management of a temporary adverse event) as long as PSA did not rise while holding therapy Prior TS in the context of neoadjuvant/concurrent/adjuvant treatment with local therapy is permitted. Prior course(s) of intermittent TS for biochemical-only recurrence is permitted. However, if the patient previously received TS, metastatic progression for which intense ADT was initiated must have occurred during an off-treatment interval and with testosterone >= 150 ng/dL Prior local therapy for prostate cancer (either before or after diagnosis of metastatic disease) is permitted. Prior treatment with docetaxel chemotherapy for up to 6 cycles is permitted. Prior radiation therapy to metastatic sites (either for symptom palliation or for ablation of oligometastatic disease) is permitted Exclusion Criteria: No history of surgical castration No history of ARPI use prior to diagnosis of mHSPC for which the patient is currently receiving intense ADT (such as in the neoadjuvant setting with prior local therapy) No current or prior treatment with experimental agents for metastatic hormone-sensitive prostate cancer Eastern Cooperative Oncology Group (ECOG) performance status 0-2 Prior to initiating intense ADT Prostate specific antigen (PSA) >= 5 ng/ml Testosterone >= 150 ng/dl. Patients are permitted to enroll if testosterone was not measured prior to initiating intense ADT for mHSPC if they did not previously receive TS and were not known or suspected to be hypogonadal at the time At time of enrollment to A032101 PSA < 0.2 ng/ml ** PSA values (measured in the same laboratory) must be stable or falling for 3 consecutive measurements - i.e. any PSA rise must be followed by a decrease in PSA that is further decreased or stable on a 3rd measurement. Any patient with 2 consecutive rises in PSA values since achieving castrate level of testosterone is not eligible Testosterone < 50 ng/dl No current participation in a clinical study that does not allow for TS or ARPI interruption No patients with a "currently active" second malignancy * Patients with non-melanomatous skin cancer, superficial bladder cancer, cancer not needing active therapy for at least 2 years, cancer for which the treating investigator deems the subject

Lead Scientists at Eisenhower Health

Delshad Ahmad, MD
Board Certified Medical Oncologist and Hematologist, Delshad Ahmad, MD, is dedicated to providing personalized cancer care for his patients and their families. He received his medical degree from Damascus University in Syria, where he also attended a residency program in internal medicine. Once in the United States, he completed a residency program in internal medicine at the Hurley Medical Center in Flint, Michigan. He then went on to complete a fellowship in Hematology/Oncology at Michigan Sta... more
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Board Certified Medical Oncologist and Hematologist, Delshad Ahmad, MD, is dedicated to providing personalized cancer care for his patients and their families. He received his medical degree from Damascus University in Syria, where he also attended a residency program in internal medicine. Once in the United States, he completed a residency program in internal medicine at the Hurley Medical Center in Flint, Michigan. He then went on to complete a fellowship in Hematology/Oncology at Michigan State University, East Lansing, Michigan. Currently, Dr. Ahmad is the Director of Thoracic Oncology at Eisenhower Lucy Curci Cancer Center (LCCC).

In his younger years, Dr. Ahmad excelled in sciences and coupled with his desire to help people and encouragement from his family he decided to pursue a medical degree while at university. During rotations in his residency program, he was drawn to the specialty of oncology (cancer) and hematology (blood diseases). “Oncology/Hematology offered me the greatest opportunity to positively affect patient’s lives,” states Dr. Ahmad. “It is a field that is in constant change, with new protocols and treatments always on the forefront of study. I am a constant learner and knew that this specialty of medicine would always challenge me.” The specialty of oncology/hematology was personal as well for Dr. Ahmad. While in medical school and residency, a close cousin was battling cancer and he became very involved with her treatment and care.

With regard to his approach to patient care, Dr. Ahmad strives to provide patients with all the options, possibilities and treatments with regard to treating their disease. “Every patient is unique and every treatment is unique,” states Dr. Ahmad. “I want to understand my patients' goals, provide them with the information they need to accomplish those and partner with them in developing their treatment plan. I am with them all along their journey toward health.”

Dr. Ahmad sees patients in Rancho Mirage, La Quinta and Yucca Valley.
 

Clinical Study Details

  1. Accepting new patients
  2. study started November 2022
  3. Interventional
  4. March 28, 2024