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Evaluating In Home Cancer Therapy Versus In Clinic Cancer Therapy In Black Men With Locally Advanced, Biochemically Recurrent And Metastatic Prostate Cancer

Jacksonville, FL
- See Details
Evaluating In Home Cancer Therapy Versus In Clinic Cancer Therapy In Black Men With Locally Advanced, Biochemically Recurrent And Metastatic Prostate Cancer
- Study type:
  Interventional
  Describes the nature of a clinical study. Types include:
  
  Observational study — observes people and measures outcomes without affecting results.
  
  Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
  
  Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
- Study phase:
  2
  During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.
About this study

This phase II trial evaluates the impact of cancer therapy in the patients' home compared to in the clinic on safety, side effects, patient preference, and satisfaction in Black men with prostate cancer that has spread to nearby tissue or lymph nodes (locally advanced), that has increasing prostate-specific antigen after treatment (biochemically recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic). Typically drug-related cancer care is conducted at a medical center which causes patients to have to spend considerable time away from family, friends, and familiar surroundings. This separation may add to the physical, emotional, social, and financial burden for patients and their families during this difficult time in their lives. Therapy administered to a patient in the patients' residence in the comfort of familiar surrounding using Cancer Connected Access and Remote Expertise (CARE) Beyond Walls (CCBW) may help reduce psychological and financial distress, increase access to care and improve treatment compliance. Giving cancer therapy in the home compared in the clinic may be safe, tolerable and improve patient satisfaction with overall cancer care in Black men with locally advanced, biochemically recurrent or metastatic prostate cancer.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Open for enrollment
View complete study & contact information

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Site IRB:
Jacksonville, Florida: 24-010825

NCT ID:
NCT07073794

Sponsor Protocol Number:
MC240507

Mayo Clinic Location	Status	Contact
Jacksonville, Fla.	Open for enrollment	View complete study & contact information

Stereotactic Body Radiotherapy Versus Hypofractionated Radiotherapy For Salvage Of Biochemically Recurrent Or Oligometastatic Prostate Adenocarcinoma After Radical Prostatectomy

Albert Lea, MN, Scottsdale/Phoenix, AZ, Eau Claire, WI, Jacksonville, FL, La Crosse, WI, Mankato, MN, Rochester, MN

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Stereotactic Body Radiotherapy Versus Hypofractionated Radiotherapy For Salvage Of Biochemically Recurrent Or Oligometastatic Prostate Adenocarcinoma After Radical Prostatectomy

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
3
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

The purpose of this study is to determine if salvage stereotactic body radiotherapy (SBRT) is non-inferior to moderately hypofractionated radiation therapy (HFRT) regarding treatment related rates of genitourinary (GU) and gastrointestinal (GI) Grade 3 or higher within 2-years.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Open for enrollment	View complete study & contact information
La Crosse, Wis.	Open for enrollment
Mankato, Minn.	Open for enrollment
Scottsdale/Phoenix, Ariz.	Open for enrollment
Eau Claire, Wis.	Open for enrollment
Jacksonville, Fla.	Closed for enrollment
Albert Lea, Minn.	Open for enrollment

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Site IRB:
- Rochester, Minnesota: 22-009244
- La Crosse, Wisconsin: 22-009244
- Mankato, Minnesota: 22-009244
- Scottsdale/Phoenix, Arizona: 22-009244
- Eau Claire, Wisconsin: 22-009244
- Jacksonville, Florida: 22-009244
- Albert Lea, Minnesota: 22-009244
NCT ID:
NCT06205316
Sponsor Protocol Number:
GMROA2255

Highly Selective CDK7 Inhibitor Q901 in Selected Advanced Solid Tumors

Scottsdale/Phoenix, AZ, Jacksonville, FL, Rochester, MN

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Highly Selective CDK7 Inhibitor Q901 in Selected Advanced Solid Tumors

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
1/2
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

The purpose of part one of this study is to determine the maximum tolerated dose (MTD), dose-limiting toxicities (DLTs), and safety profile of Q901 monotherapy when administered via intravenous (IV) infusion once-weekly (QW) for 4 weeks and once every 2 weeks (Q2W) thereafter. Also, to establish for future clinical development the recommended Phase 2 dose (RP2D) of Q901 monotherapy when administered via IV infusion QW for 4 weeks and Q2W thereafter.

The purpose of part two of this study is to evaluate safety and tolerability and evidence of anticancer activity of Q901 as monotherapy and in combination with pembrolizumab. In Part 2 Cohort 1, an expansion phase at the established RP2D will be undertaken in participants with selected advanced solid tumors. In Part 2 Cohort 2, a safety run in and expansion phase will be undertaken with Q901 at the RP2D administered in combination with pembrolizumab (400 mg Q6W) in participants with advanced solid tumors.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Open for enrollment	View complete study & contact information
Jacksonville, Fla.	Open for enrollment
Scottsdale/Phoenix, Ariz.	Open for enrollment

Print study details

Site IRB:
- Rochester, Minnesota: 22-009877
- Jacksonville, Florida: 22-009877
- Scottsdale/Phoenix, Arizona: 22-009877
NCT ID:
NCT05394103
Sponsor Protocol Number:
QRNT-009

Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01)

Scottsdale/Phoenix, AZ, Jacksonville, FL, Rochester, MN

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Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01)

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
1
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

The purpose of this study is to assess the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and the preliminary effectiveness of JANX007 administered as a single agent in adult subjects with metastatic castration-resistant prostate cancer (mCRPC).

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Open for enrollment	View complete study & contact information
Jacksonville, Fla.	Open for enrollment
Scottsdale/Phoenix, Ariz.	Open for enrollment

Print study details

Site IRB:
- Rochester, Minnesota: 25-004536
- Jacksonville, Florida: 25-004536
- Scottsdale/Phoenix, Arizona: 25-004536
NCT ID:
NCT05519449
Sponsor Protocol Number:
PSMA-007-001

A Clinical Study of Ifinatamab Deruxtecan (I-DXd) in People With Metastatic Prostate Cancer (MK-2400-001)

Scottsdale/Phoenix, AZ, Rochester, MN, Jacksonville, FL

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A Clinical Study of Ifinatamab Deruxtecan (I-DXd) in People With Metastatic Prostate Cancer (MK-2400-001)

Study type:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
3
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

Researchers are looking for new ways to treat metastatic castration-resistant prostate cancer (mCRPC). Researchers have designed a study medicine called ifinatamab deruxtecan (also called I-DXd or MK-2400) to treat mCRPC. The goal of this study is to learn if people who receive I-DXd live longer overall and live longer without the cancer growing or spreading than people who receive chemotherapy,

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Open for enrollment	View complete study & contact information
Jacksonville, Fla.	Open for enrollment
Scottsdale/Phoenix, Ariz.	Open for enrollment

Print study details

Site IRB:
- Rochester, Minnesota: 25-006761
- Jacksonville, Florida: 25-006761
- Scottsdale/Phoenix, Arizona: 25-006761
NCT ID:
NCT06925737
Sponsor Protocol Number:
2400-001

An Open-label Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan Versus Observation in PSMA Positive OMPC. (PSMA-DC)

Rochester, MN
- See Details
An Open-label Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan Versus Observation in PSMA Positive OMPC. (PSMA-DC)
- Study type:
  Interventional
  Describes the nature of a clinical study. Types include:
  
  Observational study — observes people and measures outcomes without affecting results.
  
  Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
  
  Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
- Study phase:
  3
  During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.
About this study

The purpose of this study is to evaluate the effectiveness of AAA617 versus observation after Stereotactic Body Radiation Therapy (SBRT), in delaying castration or disease recurrence in adult patients with PSMA
positive OMPC with 1 to 5 metastatic lesions detected by PSMA PET using gallium (68Ga) gozetotide or piflufolastat (18F), negative for M1 disease by conventional imaging (CI).

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Open for enrollment
View complete study & contact information

Print study details
Site IRB:
Rochester, Minnesota: 23-007167

NCT ID:
NCT05939414

Sponsor Protocol Number:
CAAA617D12302
International Registry for Men With Advanced Prostate Cancer (IRONMAN)

Jacksonville, FL
- See Details
International Registry for Men With Advanced Prostate Cancer (IRONMAN)
- Study type:
  Observational
  Describes the nature of a clinical study. Types include:
  
  Observational study — observes people and measures outcomes without affecting results.
  
  Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
  
  Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
- Study phase:
  0
  During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.
About this study

The purpose of this registry is to collect detailed clinical, epidemiological and biological information from 5,000 male patients with advanced prostate cancer.

The objectives are to describe the practice patterns of therapeutic agents for treatment of advanced prostate cancer internationally; to assess whether specific treatment patterns are associated with clinically significant adverse events, and evaluate potential interactions with concomitant medications or demographic factors; to identify associations between treatment sequences or combinations and overall survival; to define the patient experience of men with advanced prostate cancer and identify unmet needs in their treatment; and to identify clinical and molecular disease subtypes that predict response to individual treatments, combinations, or sequences.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Open for enrollment
View complete study & contact information

Print study details
Site IRB:
Jacksonville, Florida: 21-007137

NCT ID:
NCT03151629

Sponsor Protocol Number:
IRONMAN

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Search Results 1-7 of 7 for

Evaluating In Home Cancer Therapy Versus In Clinic Cancer Therapy In Black Men With Locally Advanced, Biochemically Recurrent And Metastatic Prostate Cancer

Stereotactic Body Radiotherapy Versus Hypofractionated Radiotherapy For Salvage Of Biochemically Recurrent Or Oligometastatic Prostate Adenocarcinoma After Radical Prostatectomy

Highly Selective CDK7 Inhibitor Q901 in Selected Advanced Solid Tumors

Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01)

A Clinical Study of Ifinatamab Deruxtecan (I-DXd) in People With Metastatic Prostate Cancer (MK-2400-001)

An Open-label Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan Versus Observation in PSMA Positive OMPC. (PSMA-DC)

International Registry for Men With Advanced Prostate Cancer (IRONMAN)

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