Trial Outcomes & Findings for Abemaciclib in Combination With Androgen Deprivation Therapy for Locally Advanced Prostate Cancer (NCT NCT04298983)

Last Updated: 2025-03-19

Results Overview

Clinical response rates will be assessed by percentage of patients who achieve the PSA nadir levels of \< 0.5ng/ml on treatment

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

9 participants

Primary outcome timeframe

Baseline to 24 months

Results posted on

2025-03-19

Participant Flow

Participant milestones

Participant milestones
Measure	Abemaciclib + ADT+ RT Abemaciclib at 150 mg by mouth twice daily, androgen deprivation therapy (ADT), and radiation therapy in conjunction with ADT. Abemaciclib 150 MG by mouth twice daily: Abemaciclib will start with initiation of ADT, 3 months before RT, and pause 2 weeks prior to start of RT. Abemaciclib will resume with the first ADT administration post-radiation, which is about 1 month post radiation therapy. Abemaciclib will continue for a total of 24 months. Androgen deprivation therapy (ADT): ADT will be given every 3 months. ADT and Abemaciclib will pause 2 weeks prior to start of RT. ADT administration will resume with Abemaciclib post-radiation, which is about 1 month post radiation therapy. ADT will continue for a total of 24 months. Radiation Therapy: RT will start 3 months after initiation of ADT and Abemaciclib. RT will be given as standard of care- 180 cGy x 28 fractions to the whole pelvis and the prostate will receive 250 cGy x 28 fractions. After RT is completed, both ADT and Abemaciclib will resume and continue for 24 months.
Overall Study STARTED	9
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Abemaciclib + ADT+ RT Abemaciclib at 150 mg by mouth twice daily, androgen deprivation therapy (ADT), and radiation therapy in conjunction with ADT. Abemaciclib 150 MG by mouth twice daily: Abemaciclib will start with initiation of ADT, 3 months before RT, and pause 2 weeks prior to start of RT. Abemaciclib will resume with the first ADT administration post-radiation, which is about 1 month post radiation therapy. Abemaciclib will continue for a total of 24 months. Androgen deprivation therapy (ADT): ADT will be given every 3 months. ADT and Abemaciclib will pause 2 weeks prior to start of RT. ADT administration will resume with Abemaciclib post-radiation, which is about 1 month post radiation therapy. ADT will continue for a total of 24 months. Radiation Therapy: RT will start 3 months after initiation of ADT and Abemaciclib. RT will be given as standard of care- 180 cGy x 28 fractions to the whole pelvis and the prostate will receive 250 cGy x 28 fractions. After RT is completed, both ADT and Abemaciclib will resume and continue for 24 months.
Overall Study Adverse Event	4
Overall Study Lack of Efficacy	3

Baseline Characteristics

Abemaciclib in Combination With Androgen Deprivation Therapy for Locally Advanced Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Abemaciclib + ADT+ RT n=9 Participants Abemaciclib at 150 mg by mouth twice daily, androgen deprivation therapy (ADT), and radiation therapy in conjunction with ADT. Abemaciclib 150 MG by mouth twice daily: Abemaciclib will start with initiation of ADT, 3 months before RT, and pause 2 weeks prior to start of RT. Abemaciclib will resume with the first ADT administration post-radiation, which is about 1 month post radiation therapy. Abemaciclib will continue for a total of 24 months. Androgen deprivation therapy (ADT): ADT will be given every 3 months. ADT and Abemaciclib will pause 2 weeks prior to start of RT. ADT administration will resume with Abemaciclib post-radiation, which is about 1 month post radiation therapy. ADT will continue for a total of 24 months. Radiation Therapy: RT will start 3 months after initiation of ADT and Abemaciclib. RT will be given as standard of care- 180 cGy x 28 fractions to the whole pelvis and the prostate will receive 250 cGy x 28 fractions. After RT is completed, both ADT and Abemaciclib will resume and continue for 24 months.
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=99 Participants
Age, Categorical >=65 years	4 Participants n=99 Participants
Sex: Female, Male Female	0 Participants n=99 Participants
Sex: Female, Male Male	9 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	2 Participants n=99 Participants
Race (NIH/OMB) White	6 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=99 Participants
Region of Enrollment United States	9 participants n=99 Participants

PRIMARY outcome

Timeframe: Baseline to 24 months

Population: A total of 9 patients were enrolled in the study. Two patients completed the entire protocol specified therapy. Both of these patients achieved clinical response. 4 patients were taken off study drug due to SAEs. The trial was terminated (along with the 3 remaining patients discontinuing drug) early due to negative results of a later phase clinical trial in men with metastatic prostate cancer.

Clinical response rates will be assessed by percentage of patients who achieve the PSA nadir levels of \< 0.5ng/ml on treatment

Outcome measures

Outcome measures
Measure	Abemaciclib + ADT+ RT n=2 Participants Abemaciclib at 150 mg by mouth twice daily, androgen deprivation therapy (ADT), and radiation therapy in conjunction with ADT. Abemaciclib 150 MG by mouth twice daily: Abemaciclib will start with initiation of ADT, 3 months before RT, and pause 2 weeks prior to start of RT. Abemaciclib will resume with the first ADT administration post-radiation, which is about 1 month post radiation therapy. Abemaciclib will continue for a total of 24 months. Androgen deprivation therapy (ADT): ADT will be given every 3 months. ADT and Abemaciclib will pause 2 weeks prior to start of RT. ADT administration will resume with Abemaciclib post-radiation, which is about 1 month post radiation therapy. ADT will continue for a total of 24 months. Radiation Therapy: RT will start 3 months after initiation of ADT and Abemaciclib. RT will be given as standard of care- 180 cGy x 28 fractions to the whole pelvis and the prostate will receive 250 cGy x 28 fractions. After RT is completed, both ADT and Abemaciclib will resume and continue for 24 months.
Clinical Response Rates	2 Participants

SECONDARY outcome

Timeframe: Up to 3 months of treatment

Population: A total of 9 patients were enrolled in the study. Two patients completed the entire protocol specified therapy. Both patients had PSA declines prior to radiotherpay. 4 patients were taken off study drug due to SAEs. The trial was terminated (along with the 3 remaining patients discontinuing drug) early due to negative results of a later phase clinical trial in men with metastatic prostate cancer.

Number of patients with PSA declines prior to radiotherapy- calculated from nadir level prior to initiation of radiation therapy

Outcome measures

Outcome measures
Measure	Abemaciclib + ADT+ RT n=2 Participants Abemaciclib at 150 mg by mouth twice daily, androgen deprivation therapy (ADT), and radiation therapy in conjunction with ADT. Abemaciclib 150 MG by mouth twice daily: Abemaciclib will start with initiation of ADT, 3 months before RT, and pause 2 weeks prior to start of RT. Abemaciclib will resume with the first ADT administration post-radiation, which is about 1 month post radiation therapy. Abemaciclib will continue for a total of 24 months. Androgen deprivation therapy (ADT): ADT will be given every 3 months. ADT and Abemaciclib will pause 2 weeks prior to start of RT. ADT administration will resume with Abemaciclib post-radiation, which is about 1 month post radiation therapy. ADT will continue for a total of 24 months. Radiation Therapy: RT will start 3 months after initiation of ADT and Abemaciclib. RT will be given as standard of care- 180 cGy x 28 fractions to the whole pelvis and the prostate will receive 250 cGy x 28 fractions. After RT is completed, both ADT and Abemaciclib will resume and continue for 24 months.
Number of Patients With PSA Declines Prior to Radiotherapy	2 Participants

SECONDARY outcome

Timeframe: Baseline up to 24 months

Population: A total of 9 patients were enrolled in the study. Two patients completed the entire protocol specified therapy. The two patients were analyzed and neither experienced PSA failure. 4 patients were taken off study drug due to SAEs. The trial was terminated (along with the 3 remaining patients discontinuing drug) early due to negative results of a later phase clinical trial in men with metastatic prostate cancer.

Number of patients to experience PSA failure will be analyzed using the Kaplan-Meier method

Outcome measures

Outcome measures
Measure	Abemaciclib + ADT+ RT n=2 Participants Abemaciclib at 150 mg by mouth twice daily, androgen deprivation therapy (ADT), and radiation therapy in conjunction with ADT. Abemaciclib 150 MG by mouth twice daily: Abemaciclib will start with initiation of ADT, 3 months before RT, and pause 2 weeks prior to start of RT. Abemaciclib will resume with the first ADT administration post-radiation, which is about 1 month post radiation therapy. Abemaciclib will continue for a total of 24 months. Androgen deprivation therapy (ADT): ADT will be given every 3 months. ADT and Abemaciclib will pause 2 weeks prior to start of RT. ADT administration will resume with Abemaciclib post-radiation, which is about 1 month post radiation therapy. ADT will continue for a total of 24 months. Radiation Therapy: RT will start 3 months after initiation of ADT and Abemaciclib. RT will be given as standard of care- 180 cGy x 28 fractions to the whole pelvis and the prostate will receive 250 cGy x 28 fractions. After RT is completed, both ADT and Abemaciclib will resume and continue for 24 months.
Number of Patients to Experience PSA Failure	0 Participants

Adverse Events

Abemaciclib + ADT+ RT

Serious events: 4 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Abemaciclib + ADT+ RT n=9 participants at risk Abemaciclib at 150 mg by mouth twice daily, androgen deprivation therapy (ADT), and radiation therapy in conjunction with ADT. Abemaciclib 150 MG by mouth twice daily: Abemaciclib will start with initiation of ADT, 3 months before RT, and pause 2 weeks prior to start of RT. Abemaciclib will resume with the first ADT administration post-radiation, which is about 1 month post radiation therapy. Abemaciclib will continue for a total of 24 months. Androgen deprivation therapy (ADT): ADT will be given every 3 months. ADT and Abemaciclib will pause 2 weeks prior to start of RT. ADT administration will resume with Abemaciclib post-radiation, which is about 1 month post radiation therapy. ADT will continue for a total of 24 months. Radiation Therapy: RT will start 3 months after initiation of ADT and Abemaciclib. RT will be given as standard of care- 180 cGy x 28 fractions to the whole pelvis and the prostate will receive 250 cGy x 28 fractions. After RT is completed, both ADT and Abemaciclib will resume and continue for 24 months.
Investigations Lipase Increased	44.4% 4/9 • Each participant was assessed up to 24 months.

Other adverse events

Adverse event data not reported

Additional Information

Andrew McDonald, MD; Principal Investigator

University of Alabama at Birmingham (UAB)

Phone: 2059345670

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place