Localized Prostate CarcinomaGREENSNCT06500169
Golf Recreational Exercise for Enhanced Survivorship in Prostate Cancer Survivors
A study testing Biospecimen Collection, Discussion and Exercise Intervention in people with Localized Prostate Carcinoma and Locally Advanced Prostate Carcinoma, run by University of Southern California at 2 sites in United States.
Trial summary
This clinical trial evaluates a golf recreational exercise program for enhancing survivorship in underrepresented prostate cancer survivors. Golf is a multimodal recreational activity that requires participants to utilize all muscle groups to perform the golf swing, walk over hilly and uneven terrain, maintain balance… Read more about this study
- Who is it for?
- Ages 55 to 85 years, men only
- Conditions the study is for
- Localized Prostate Carcinoma, Locally Advanced Prostate Carcinoma, Stage I Prostate Cancer American Joint Committee on Cancer (AJCC) v8
- What is being tested?
- Biospecimen Collection, Discussion and Exercise Intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Sep 2023to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First time, primary diagnosis of prostate cancer (PCa)
- Currently receiving androgen deprivation therapy (ADT) and/or androgen receptor blocker) for more than 6 months
- Older adult male: 55-85 years old
- The ability to stand independently without external support
- No or minimal golf experience (played < 5 times in the past 10 years)
- English speaking
Who cannot join
- Second cancer diagnosis (excluding non-invasive skin cancers) or bone metastases
- Prostatectomy less than 6 months prior to study enrollment (prostatectomy is not a requirement for study entry)
- Symptomatic cardiovascular disease, active angina, uncontrolled hypertension (systolic blood pressure (SBP) > 160 or diastolic blood pressure (DBP) > 90, high resting pulse heart rate (HR) > 90), symptomatic orthostatic hypotension
- Unstable asthma, exacerbated chronic obstructive pulmonary disease (COPD]
- History of injury or orthopedic operation within the last 6 months
- Movement disorders (e.g., Parkinson's disease (PD) or other neurological disorders), hemiparesis or paraparesis
- Severe vision or hearing problems
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Los Angeles General Medical Center
Los Angeles, California, 90033
George Salem, PhD, 323-442-3113, gsalem@usc.edu
George Salem, PhD
- Recruiting
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
George Salem, PhD, 323-442-3113, gsalem@usc.edu
George Salem, PhD
About this study
Official title: Golf Recreational Exercise for Enhanced Survivorship in Prostate Cancer Survivors Undergoing Hormone Therapy (GREENS)
This clinical trial evaluates a golf recreational exercise program for enhancing survivorship in underrepresented prostate cancer survivors. Golf is a multimodal recreational activity that requires participants to utilize all muscle groups to perform the golf swing, walk over hilly and uneven terrain, maintain balance during putting and squat-like tasks. Physical activity and exercise are beneficial to physical function, cognitive function, psychosocial health, and overall quality of life during prostate cancer survivorship. These aspects of health are impacted by prostate cancer treatment, especially androgen deprivation therapy. Additionally, supervised, group-based activity programs facilitate participation in physical activity. Researchers want to examine the changes in functional abilities, psychosocial health, and quality of life following participation in in a golf program designed for prostate cancer survivors.
Read the detailed description
PRIMARY OBJECTIVES:
- To recruit, screen, and enroll prostate cancer survivors. II. To examine the safety, feasibility, and adherence, of the 10-week (wk) GREENS program.
III. To analyze the pre-post intervention data and examine the effects (assessed by Hedges g) of the program on:
IIIa. Physical capacity; IIIb. Psychosocial wellness; IIIc. Health, and; IIId. Cognition.
OUTLINE:
Patients participate in the golf training program composed of group sessions over 1-2 hours with a Professional Golfers' Association of America (PGA) professional two times per week for ten weeks. Training consists of complimentary/warm up exercises integrated with pelvic floor muscle training, golf instruction, golf practice, and golf play on a Par 3 public golf course. Patients also wear an activity tracker and undergo blood sample collection on the study.
After completion of study intervention, patients are followed up at 6 months.
- Conditions
- Localized Prostate Carcinoma, Locally Advanced Prostate Carcinoma, Stage I Prostate Cancer American Joint Committee on Cancer (AJCC) v8, Stage II Prostate Cancer AJCC v8, Stage III Prostate Cancer AJCC v8
- Being tested
- Biospecimen Collection, Discussion, Exercise Intervention, Interview, Medical Device Usage and Evaluation
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo blood sample collection
DiscussionProcedure or surgery
Also called Discuss
Ancillary studies
Complete golf related exercises
InterviewOther
Ancillary studies
Medical Device Usage and EvaluationOther
Wear activity tracker
Physical ExaminationProcedure or surgery
Also called Assessment, General Examination, Physical, Physical Assessment
Ancillary studies
Physical Performance TestingOther
Also called Physical Fitness Testing, Physical Function Testing
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
Recreational TherapyOther
Participate in golf program
| Study group | Role | What they receive |
|---|---|---|
| Supportive care (golf program) | Experimental | Patients participate in the golf training program composed of group sessions over 1-2 hours with a PGA professional two times per week for ten weeks. Training consists of complimentary/warm up exercises integrated with pelvic floor muscle training, golf instruction, golf practice, and golf play on a Par 3 public golf course. Patients also wear an activity tracker and undergo blood sample collection on the study. Receives: Procedure: Biospecimen Collection; Procedure: Discussion; Other: Exercise Intervention; Other: Interview; Other: Medical Device Usage and Evaluation; Procedure: Physical Examination; Other: Physical Performance Testing; Other: Questionnaire Administration; Other: Recreational Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment rate
Will be defined as the final number of enrolled individuals / the number of qualified individuals screened.
Measured: Up to 3 years
Participant adherence to the program
Will be assessed by the number of participants who adhere to the study and attend > 80% of supervised training sessions.
Measured: Up to 3 years
Cost of the program
Will be assessed by the cost that the program will be < $1,000/participant.
Measured: Up to 3 years
Staff adherence
Will be assessed by trained staff who attend > 90% of scheduled sessions.
Measured: Up to 3 years
Program accommodations
Will be defined as the program accommodating course scheduling for > 95% of training sessions.
Measured: Up to 3 years
Incidence of adverse events
Will be assessed across all participants, and defined by less than 3 program-related adverse events (AEs) and any/all AEs will be mild (grade 3 or below according to Common Terminology Criteria for Adverse Events version 5).
Measured: Up to 3 years
Quality of life scores
Will be assessed by the Functional Assessment of Cancer Therapy - Prostate (FACT-P), a 39-item self-reported questionnaire. FACT-P scores range from 0 to 156, with higher scores indicating a better quality of life. It is expected that the scores will improve with medium to large effect sizes and exceed the established minimal clinically important difference (MCID).
Measured: Up to 3 years
Circulating inflammatory biomarker levels
Will be assessed by C-reactive protein and tumor necrosis factor alpha (TNFa) which are indicators of inflammation. Based on prior study, C-reactive protein and TNFa levels are expected to decrease with medium to large effect sizes and exceed the calculated MCID levels.
Measured: Up to 3 years
Senior fitness test scores
Will be assessed by Short physical performance battery (SPPB). The SPPB is scored out of 12 points and higher score indicates better performance. The SPPB is a reliable (intraclass correlation coefficient [ICC] was between 0.82-0.92) and validated (MDC=2; MCID=1-3) measure for physical capacity in community-dwelling and clinical older adults.
Measured: Up to 3 years
Gait speed
Will be assessed with self-selected gait and fast gait using a 10-feet designated walkway and timing device. Faster gait speeds in both condition indicate higher physical capacity. For reference, men in the 60-65 years age group, gait speeds over 1.53 m/s is considered above 80th percentile.
Measured: Up to 3 years
Balance Confidence
Will be assessed by Activities-specific Balance Confidence (ABC) scale, a 16-item self-reported questionnaire. The ABC is scored from 0% to 100%, where higher scores indicate greater confidence in maintaining balance during activities.
Measured: Up to 3 years
Cognitive function
Will be assessed by the Food and Drug Administration approved Sway Medical application (app) designed to assess cognition with a smart phone device and will be used to assess cognitive function. The app includes validated tests for processing speed, sensory processing, neuromotor response speed, inhibition, memory, and executive function, which are areas of cognitive function that are potentially influenced by prostate cancer treatments. The app has established normative values for different age group and will be used as reference.
Measured: Up to 3 years
Participant feedback of the program
Will be assessed by a semi-structured focus group that will be conducted post intervention where participants will be asked about positive affect and negative affect associated with the intervention, their perceived mastery of different components of golf (i.e. putting, chipping, golf swing, etiquette, rules, etc.), facilitators and barriers that pertained to their participation in the intervention. These assessments will provide information unique to prostate cancer survivors and be used directly to improve the protocol and intervention design for future studies in this population. The facilitators and barriers will also be compared to established ones reported by Sattar et al. to qualitatively assess whether they are similar with our diverse cohort of minority participants located in Los Angeles, California.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2024
- Study start1 Sep 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Localized Prostate CarcinomaStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- George Salem, PhD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06500169
- Sponsor's protocol ID
- 4P-23-4
- Other IDs
- NCI-2023-09213, 4P-23-4, P30CA014089
- Acronym
- GREENS
- Status last verified
- May 2026
- First submitted
- 24 May 2024
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Golf Recreational Exercise for Enhanced Survivorship in Prostate Cancer Survivors Undergoing Hormone Therapy (GREENS)
- ClinicalTrials.gov ID
- NCT06500169
- Acronym / sponsor ID
- GREENS / 4P-23-4
- Conditions
- Localized Prostate Carcinoma, Locally Advanced Prostate Carcinoma, Stage I Prostate Cancer American Joint Committee on Cancer (AJCC) v8, Stage II Prostate Cancer AJCC v8, Stage III Prostate Cancer AJCC v8
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 15 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial evaluates a golf recreational exercise program for enhancing survivorship in underrepresented prostate cancer survivors. Golf is a multimodal recreational activity that requires participants to utilize all muscle groups to perform the golf swing, walk over hilly and uneven terrain, maintain balance during putting and squat-like tasks. Physical activity and exercise are beneficial to physical function, cognitive function, psychosocial health, and overall quality of life during prostate cancer survivorship. These aspects of health are impacted by prostate cancer treatment, especially androgen deprivation therapy. Additionally, supervised, group-based activity programs facilitate participation in physical activity. Researchers want to examine the changes in functional abilities, psychosocial health, and quality of life following participation in in a golf program designed for prostate cancer survivors.
Detailed description
PRIMARY OBJECTIVES:
- To recruit, screen, and enroll prostate cancer survivors. II. To examine the safety, feasibility, and adherence, of the 10-week (wk) GREENS program.
III. To analyze the pre-post intervention data and examine the effects (assessed by Hedges g) of the program on:
IIIa. Physical capacity; IIIb. Psychosocial wellness; IIIc. Health, and; IIId. Cognition.
OUTLINE:
Patients participate in the golf training program composed of group sessions over 1-2 hours with a Professional Golfers' Association of America (PGA) professional two times per week for ten weeks. Training consists of complimentary/warm up exercises integrated with pelvic floor muscle training, golf instruction, golf practice, and golf play on a Par 3 public golf course. Patients also wear an activity tracker and undergo blood sample collection on the study.
After completion of study intervention, patients are followed up at 6 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (golf program) | Experimental | Procedure: Biospecimen Collection, Procedure: Discussion, Other: Exercise Intervention, Other: Interview, Other: Medical Device Usage and Evaluation, Procedure: Physical Examination, Other: Physical Performance Testing, Other: Questionnaire Administration, Other: Recreational TherapyPatients participate in the golf training program composed of group sessions over 1-2 hours with a PGA professional two times per week for ten weeks. Training consists of complimentary/warm up exercises integrated with pelvic floor muscle training, golf instruction, golf practice, and golf play on a Par 3 public golf course. Patients also wear an activity tracker and undergo blood sample collection on the study. |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- First time, primary diagnosis of prostate cancer (PCa)
- Currently receiving androgen deprivation therapy (ADT) and/or androgen receptor blocker) for more than 6 months
- Older adult male: 55-85 years old
- The ability to stand independently without external support
- No or minimal golf experience (played < 5 times in the past 10 years)
Key exclusion criteria (7 listed)
- Second cancer diagnosis (excluding non-invasive skin cancers) or bone metastases
- Prostatectomy less than 6 months prior to study enrollment (prostatectomy is not a requirement for study entry)
- Symptomatic cardiovascular disease, active angina, uncontrolled hypertension (systolic blood pressure (SBP) > 160 or diastolic blood pressure (DBP) > 90, high resting pulse heart rate (HR) > 90), symptomatic orthostatic hypotension
- Unstable asthma, exacerbated chronic obstructive pulmonary disease (COPD]
- History of injury or orthopedic operation within the last 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo blood sample collection | Procedure or surgery | Supportive care (golf program) |
| DiscussionAlso: DiscussAncillary studies | Procedure or surgery | Supportive care (golf program) |
| Exercise InterventionComplete golf related exercises | Other | Supportive care (golf program) |
| InterviewAncillary studies | Other | Supportive care (golf program) |
| Medical Device Usage and EvaluationWear activity tracker | Other | Supportive care (golf program) |
| Physical ExaminationAlso: Assessment, General Examination, Physical, Physical AssessmentAncillary studies | Procedure or surgery | Supportive care (golf program) |
| Physical Performance TestingAlso: Physical Fitness Testing, Physical Function TestingAncillary studies | Other | Supportive care (golf program) |
| Questionnaire AdministrationAncillary studies | Other | Supportive care (golf program) |
| Recreational TherapyParticipate in golf program | Other | Supportive care (golf program) |
Primary outcome
Enrollment rate
Time frame: Up to 3 years
Will be defined as the final number of enrolled individuals / the number of qualified individuals screened.
Participant adherence to the program
Time frame: Up to 3 years
Will be assessed by the number of participants who adhere to the study and attend > 80% of supervised training sessions.
Cost of the program
Time frame: Up to 3 years
Will be assessed by the cost that the program will be < $1,000/participant.
Staff adherence
Time frame: Up to 3 years
Will be assessed by trained staff who attend > 90% of scheduled sessions.
Program accommodations
Time frame: Up to 3 years
Will be defined as the program accommodating course scheduling for > 95% of training sessions.
Incidence of adverse events
Time frame: Up to 3 years
Will be assessed across all participants, and defined by less than 3 program-related adverse events (AEs) and any/all AEs will be mild (grade 3 or below according to Common Terminology Criteria for Adverse Events version 5).
Quality of life scores
Time frame: Up to 3 years
Will be assessed by the Functional Assessment of Cancer Therapy - Prostate (FACT-P), a 39-item self-reported questionnaire. FACT-P scores range from 0 to 156, with higher scores indicating a better quality of life. It is expected that the scores will improve with medium to large effect sizes and exceed the established minimal clinically important difference (MCID).
Circulating inflammatory biomarker levels
Time frame: Up to 3 years
Will be assessed by C-reactive protein and tumor necrosis factor alpha (TNFa) which are indicators of inflammation. Based on prior study, C-reactive protein and TNFa levels are expected to decrease with medium to large effect sizes and exceed the calculated MCID levels.
Senior fitness test scores
Time frame: Up to 3 years
Will be assessed by Short physical performance battery (SPPB). The SPPB is scored out of 12 points and higher score indicates better performance. The SPPB is a reliable (intraclass correlation coefficient [ICC] was between 0.82-0.92) and validated (MDC=2; MCID=1-3) measure for physical capacity in community-dwelling and clinical older adults.
Gait speed
Time frame: Up to 3 years
Will be assessed with self-selected gait and fast gait using a 10-feet designated walkway and timing device. Faster gait speeds in both condition indicate higher physical capacity. For reference, men in the 60-65 years age group, gait speeds over 1.53 m/s is considered above 80th percentile.
Balance Confidence
Time frame: Up to 3 years
Will be assessed by Activities-specific Balance Confidence (ABC) scale, a 16-item self-reported questionnaire. The ABC is scored from 0% to 100%, where higher scores indicate greater confidence in maintaining balance during activities.
Cognitive function
Time frame: Up to 3 years
Will be assessed by the Food and Drug Administration approved Sway Medical application (app) designed to assess cognition with a smart phone device and will be used to assess cognitive function. The app includes validated tests for processing speed, sensory processing, neuromotor response speed, inhibition, memory, and executive function, which are areas of cognitive function that are potentially influenced by prostate cancer treatments. The app has established normative values for different age group and will be used as reference.
Participant feedback of the program
Time frame: Up to 3 years
Will be assessed by a semi-structured focus group that will be conducted post intervention where participants will be asked about positive affect and negative affect associated with the intervention, their perceived mastery of different components of golf (i.e. putting, chipping, golf swing, etiquette, rules, etc.), facilitators and barriers that pertained to their participation in the intervention. These assessments will provide information unique to prostate cancer survivors and be used directly to improve the protocol and intervention design for future studies in this population. The facilitators and barriers will also be compared to established ones reported by Sattar et al. to qualitatively assess whether they are similar with our diverse cohort of minority participants located in Los Angeles, California.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
George Salem, PhD principal investigator
University of Southern California
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biospecimen Collection, Discussion and Exercise Intervention in people with Localized Prostate Carcinoma and Locally Advanced Prostate Carcinoma, run by University of Southern California at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Garry Cai ((323)442-3113, Guanrong@usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment rate (time frame: Up to 3 years). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.