Trial Outcomes & Findings for PET Scanning to Evaluate Zoledronate Efficacy in Metastatic Prostate Cancer (NCT NCT01205646)

Results Overview

PET response rate was pre-defined in Section 5.0 of the protocol based on the magnitude of change in the mean standardized uptake value (SUVmean), which is measured at each PET scan. Specifically, a decline in SUVmean of at least 15% pre/post Zometa was taken as evidence of a "PET response". Per the protocol, Scan 2 was used as the pre-Zometa measure of SUVmean, and Scan 3 (1-2 weeks later) was used as the post-Zometa measure of SUVmean.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

11 participants

Primary outcome timeframe

Within 3 weeks

Results posted on

2019-04-12

Participant Flow

Participant milestones

Participant milestones
Measure	Zometa & PET Scans Zoledronate therapy \& PET scan ;2 scans \[about 1-2 weeks apart\] will be obtained over a period of 2 weeks pretherapy to confirm reproducibility, Bone scan (within 4 weeks prior to registration), bone turnover markers, and PSA will be obtained pretherapy. After that, Zometa will be administered at a dose of 4mg IV over 15 minutes. A third PET scan will be obtained within 1-2 weeks after Zometa administration. zoledronate therapy: Zometa will be administered at a dose of 4mg IV over 15 minutes. A third PET scan will be obtained within 1-2 weeks after Zometa administration. Intravenous (through a vein in the arm) infusion every four weeks. Dose will be determined by kidney function. PET Scan: 2 scans \[about 1-2 weeks apart\] will be obtained over a period of 2 weeks pretherapy to confirm reproducibility.A third PET scan will be obtained within 1-2 weeks after Zometa administration.
Overall Study STARTED	11
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

PET Scanning to Evaluate Zoledronate Efficacy in Metastatic Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Zometa & PET Scans n=11 Participants Zoledronate therapy \& PET scan ;2 scans \[about 1-2 weeks apart\] will be obtained over a period of 2 weeks pretherapy to confirm reproducibility, Bone scan (within 4 weeks prior to registration), bone turnover markers, and PSA will be obtained pretherapy. After that, Zometa will be administered at a dose of 4mg IV over 15 minutes. A third PET scan will be obtained within 1-2 weeks after Zometa administration. zoledronate therapy: Zometa will be administered at a dose of 4mg IV over 15 minutes. A third PET scan will be obtained within 1-2 weeks after Zometa administration. Intravenous (through a vein in the arm) infusion every four weeks. Dose will be determined by kidney function. PET Scan: 2 scans \[about 1-2 weeks apart\] will be obtained over a period of 2 weeks pretherapy to confirm reproducibility.A third PET scan will be obtained within 1-2 weeks after Zometa administration.
Age, Continuous	64.09 years STANDARD_DEVIATION 4.53 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants

PRIMARY outcome

Timeframe: Within 3 weeks

PET response rate was pre-defined in Section 5.0 of the protocol based on the magnitude of change in the mean standardized uptake value (SUVmean), which is measured at each PET scan. Specifically, a decline in SUVmean of at least 15% pre/post Zometa was taken as evidence of a "PET response". Per the protocol, Scan 2 was used as the pre-Zometa measure of SUVmean, and Scan 3 (1-2 weeks later) was used as the post-Zometa measure of SUVmean.

Outcome measures

Outcome measures
Measure	Zometa & PET Scans n=11 Participants Zoledronate therapy \& PET scan ;2 scans \[about 1-2 weeks apart\] will be obtained over a period of 2 weeks pretherapy to confirm reproducibility, Bone scan (within 4 weeks prior to registration), bone turnover markers, and PSA will be obtained pretherapy. After that, Zometa will be administered at a dose of 4mg IV over 15 minutes. A third PET scan will be obtained within 1-2 weeks after Zometa administration. zoledronate therapy: Zometa will be administered at a dose of 4mg IV over 15 minutes. A third PET scan will be obtained within 1-2 weeks after Zometa administration. Intravenous (through a vein in the arm) infusion every four weeks. Dose will be determined by kidney function. PET Scan: 2 scans \[about 1-2 weeks apart\] will be obtained over a period of 2 weeks pretherapy to confirm reproducibility.A third PET scan will be obtained within 1-2 weeks after Zometa administration.
PET Response Rate in Metastatic Prostate Cancer Patients Treated With Zoledronate Therapy.	.091 Proportion of participants with response Interval 0.021 to 0.323

SECONDARY outcome

Timeframe: Four weeks after initiating Zoledronate therapy

Population: All patients who had their PSA measured both before and after therapy.

The change in PSA after zoledronate therapy using per cent change.

Outcome measures

Outcome measures
Measure	Zometa & PET Scans n=10 Participants Zoledronate therapy \& PET scan ;2 scans \[about 1-2 weeks apart\] will be obtained over a period of 2 weeks pretherapy to confirm reproducibility, Bone scan (within 4 weeks prior to registration), bone turnover markers, and PSA will be obtained pretherapy. After that, Zometa will be administered at a dose of 4mg IV over 15 minutes. A third PET scan will be obtained within 1-2 weeks after Zometa administration. zoledronate therapy: Zometa will be administered at a dose of 4mg IV over 15 minutes. A third PET scan will be obtained within 1-2 weeks after Zometa administration. Intravenous (through a vein in the arm) infusion every four weeks. Dose will be determined by kidney function. PET Scan: 2 scans \[about 1-2 weeks apart\] will be obtained over a period of 2 weeks pretherapy to confirm reproducibility.A third PET scan will be obtained within 1-2 weeks after Zometa administration.
The Change in PSA After Zoledronate Therapy	38.99 percentage of change in PSA Interval -34.09 to 408.89

SECONDARY outcome

Timeframe: Four weeks after initiating zoledronate therapy

Population: Sample population

Change in bone scans using per cent change in SUVmax.

Outcome measures

Outcome measures
Measure	Zometa & PET Scans n=11 Participants Zoledronate therapy \& PET scan ;2 scans \[about 1-2 weeks apart\] will be obtained over a period of 2 weeks pretherapy to confirm reproducibility, Bone scan (within 4 weeks prior to registration), bone turnover markers, and PSA will be obtained pretherapy. After that, Zometa will be administered at a dose of 4mg IV over 15 minutes. A third PET scan will be obtained within 1-2 weeks after Zometa administration. zoledronate therapy: Zometa will be administered at a dose of 4mg IV over 15 minutes. A third PET scan will be obtained within 1-2 weeks after Zometa administration. Intravenous (through a vein in the arm) infusion every four weeks. Dose will be determined by kidney function. PET Scan: 2 scans \[about 1-2 weeks apart\] will be obtained over a period of 2 weeks pretherapy to confirm reproducibility.A third PET scan will be obtained within 1-2 weeks after Zometa administration.
Change in Bone Scans	-10.08 percentage of change of SUVmax Interval -43.84 to 54.78

SECONDARY outcome

Timeframe: Four weeks after initiating zoledronte therapy

Population: Patients who had both pre-treatment and post-treatment measures of BSAP and NTx.

Changes in bone turnover markers using per cent change of BSAP and NTx

Outcome measures

Outcome measures
Measure	Zometa & PET Scans n=11 Participants Zoledronate therapy \& PET scan ;2 scans \[about 1-2 weeks apart\] will be obtained over a period of 2 weeks pretherapy to confirm reproducibility, Bone scan (within 4 weeks prior to registration), bone turnover markers, and PSA will be obtained pretherapy. After that, Zometa will be administered at a dose of 4mg IV over 15 minutes. A third PET scan will be obtained within 1-2 weeks after Zometa administration. zoledronate therapy: Zometa will be administered at a dose of 4mg IV over 15 minutes. A third PET scan will be obtained within 1-2 weeks after Zometa administration. Intravenous (through a vein in the arm) infusion every four weeks. Dose will be determined by kidney function. PET Scan: 2 scans \[about 1-2 weeks apart\] will be obtained over a period of 2 weeks pretherapy to confirm reproducibility.A third PET scan will be obtained within 1-2 weeks after Zometa administration.
Changes in Bone Turnover Markers BSAP	-1.66 percentage of change in bio-marker Interval -29.8 to 44.08
Changes in Bone Turnover Markers NTx	-68.18 percentage of change in bio-marker Interval -82.35 to -50.0

Adverse Events

Zometa & PET Scans

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Zometa & PET Scans n=11 participants at risk Zoledronate therapy \& PET scan ;2 scans \[about 1-2 weeks apart\] will be obtained over a period of 2 weeks pretherapy to confirm reproducibility, Bone scan (within 4 weeks prior to registration), bone turnover markers, and PSA will be obtained pretherapy. After that, Zometa will be administered at a dose of 4mg IV over 15 minutes. A third PET scan will be obtained within 1-2 weeks after Zometa administration. zoledronate therapy: Zometa will be administered at a dose of 4mg IV over 15 minutes. A third PET scan will be obtained within 1-2 weeks after Zometa administration. Intravenous (through a vein in the arm) infusion every four weeks. Dose will be determined by kidney function. PET Scan: 2 scans \[about 1-2 weeks apart\] will be obtained over a period of 2 weeks pretherapy to confirm reproducibility.A third PET scan will be obtained within 1-2 weeks after Zometa administration.
Musculoskeletal and connective tissue disorders Myalgias	18.2% 2/11 • Number of events 2
General disorders Chills	9.1% 1/11 • Number of events 1

Additional Information

Ulka Vaishampayan, M.D.

Barbara Ann Karmanos Cancer Institute

Phone: (313) 576-8718

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place