Table 2.

Recommendations and voting results

	Yes		No		Indeterminate
	No./14	%	No./14	%	No./14	%
1. ADT as primary therapy for localized PC
Is there a role for ADT alone as primary therapy for patients with newly diagnosed, localized, asymptomatic PC?	1	7	13	93	0	0
2. ADT as neoadjuvant and adjuvant therapy to RP
Is there a role for neoadjuvant ADT with RP for low‐ to intermediate‐risk patients?	0	0	13	93	1	7
Is there a role for neoadjuvant ADT with RP for high‐risk patients?	1	7	10	71	3	22
Is there a role for adjuvant ADT following RP (N1, +/− EBR)?	14	100
Is there a role for adjuvant ADT following RP (N0, but other high‐risk features, absence of radiation)?	0	0	12	86	2	14
Is there a role for ADT with radiation therapy?	14	100
Low‐risk patients (except for reduction of volume)			14	100
Intermediate‐risk patients (4‐6 months duration)	14	100
High‐risk patients (18‐36 months duration)	14	100
Timing: 1‐2 months before RT	14	100
For intermediate‐ and high‐risk PC patients, pending RT and ADT, we recommend ADT initiation ideally 1‐2 months before initiating RT	14	100
Given the natural history of PC (ie, about 1/3 of patients will go on to progress), the majority of patients with BCR should undergo observation with BCR. For the remaining patients (high risk), ADT would generally be considered for:	14	100
Early recurrence (BCR <3), AND High‐risk features (PSADT ≤9 months OR Gleason score ≥8)
ADT in BCR is generally not recommended in patients with:	14	100
Low‐risk features (PSADT >15 months), AND Gleason score ≤7, OR Limited life expectancy, or low risk of metastases, or poor performance status
When considering ADT in high‐risk patients with BCR post‐RP, post‐RT, or postsalvage after RP, intermittent ADT is a reasonable alternative to continuous ADT	12	86			2	14
Proposed Intermittent Treatment Pathway (Figure 1)	13	93			1	7
There is level 1 evidence to support ADT use with salvage radiotherapy. It is reasonable to consider ADT in the setting of salvage radiotherapy as part of a shared decision‐making discussion. The duration of ADT in this setting is unclear, but 6‐12 months of ADT would be reasonable	12	86	1	7	1	7
3. ADT for M1 HSPC and M1 CRPC
In men with asymptomatic oligometastatic mCSPC (without visceral metastases), metastasis‐directed therapy may be a reasonable alternative to immediate ADT in select patients	7	50	4	29	3	21
In mCSPC, continuous ADT is generally strongly preferred over intermittent ADT, however in certain circumstances (eg, cardiovascular comorbidities, intolerabilities, etc), intermittent may be considered	13	93			1	7
In mCSPC, there are 3 options to achieve castration: bilateral orchiectomy, LHRH agonists, or LHRH antagonists	13	93			1	7
CAB (ie, LHRHa, LHRHantag, +1st‐ or 2nd‐generation antiandrogen) is superior to castration alone	9	64	5	36
In mCSPC, baseline T levels should be obtained before starting ADT	14	100
For ADT administration, testosterone level should be T < 20 ng/dL. Confirm castrate T levels 1‐4 months after surgical/medical castration, regardless of PSA levels. If PSA rises, T levels must be checked. If T levels are >20 ng/dL, clinicians should check luteinizing hormone levels to differentiate whether ADT was administered effectively	14	100
In mCSPC, if T > 20 ng/dL despite low luteinizing hormone levels, consider switching to an alternative agent	14	100
In the broad mCSPC population, ADT + Abi is superior to ADT alone in terms of OS	14	100
In mCSPC, the distinction between low‐ and high‐volume disease has not been studied in this context. Thus, ADT + Abi is a reasonable standard of care irrespective of metastatic burden	12	86			2	14
In the broad mCSPC population, ADT + docetaxel is superior to ADT alone in terms of OS	14	100
In high‐volume mCSPC, there is an unequivocal OS benefit to ADT + docetaxel vs ADT alone In low‐volume mCSPC, there no clear OS benefit to ADT + docetaxel vs ADT alone Docetaxel treatment can start 6‐16 wk after ADT, to avoid toxicities
In low‐volume mCSPC, there is evidence that ADT + docetaxel does not provide an OS benefit; thus, ADT + Abi is the favored choice	13	93	1	93
In high‐volume mCSPC, there is strong evidence of benefit for ADT + docetaxel. Thus, both ADT + abiraterone or ADT + docetaxel are treatment options	14	100
The panel cannot comment on the comparative efficacy of ADT + Abi in low‐ vs high‐volume mCSPC, because this has not been studied	14	100
mCRPC is defined as:	14	100
mPC (by conventional radiology)
Testosterone level <50 ng/dL
Progressive disease (one or more of):
PSA progression (2 rises above a nadir, ≥4 weeks apart) Radiographic progression (as defined by the Prostate Cancer Working Group 2: at least 2 new bone lesions on a CT or MRI scan) Unequivocal clinical progression (bone pain progression requiring narcotics or palliative radiotherapy, pathological fracture, urinary obstruction, or spinal cord compression)
In mCRPC, continuation of ADT to maintain T < 20 ng/dL is strongly recommended	14	100
Another reasonable option (“value‐based model”) in treating mCRPC is to stop ADT (once castrate levels are reached) and to check T levels q3 months, then restart ADT if T rises above >20 ng/dL	2	14	6	43	6	43
For patients with mCRPC on treatment, testosterone levels should be measured:	14	100
At baseline  When changing therapy  If PSA rising (to confirm castrate level: <20 ng/dL)
Also, PSA and CT/bone scans should be performed at regular intervals
4. AE Management Strategies with ADT
Should a DEXA scan and FRAX score be obtained for baseline and follow‐up testing of bone fragility during treatment with ADT (pending approval by insurance provider)?	14	100
A DEXA scan should be obtained at baseline (within 6 months of initiating ADT) and at least once every 2 years for follow‐up	14
Vitamin D levels can be monitored in men taking osteoclast inhibitors, up to annually, or more often if replenishing depleted stores with high‐dose vitamin D. Daily maintenance doses for vitamin D supplementation should be 800‐1000 IU daily, and calcium daily maintenance dosing should not exceed 1200 mg daily	13	93			1	7
The NCCN guidelines on determining which patients are eligible for additional pharmacologic therapy should be followed (ie calculating a patient's individual risk of fracture via FRAX calculator). For those patients who are eligible, zoledronic acid or denosumab can be used.	14	100
Either the urologist or the PCP should monitor blood pressure (at each visit), HbA1c (annually in nondiabetic patients), and lipid profile (annually) in patients receiving ADT	13	93			1	7
Before initiating ADT, patients with CVD comorbidities should be referred to a cardiologist for comanagement	14	100
There is no evidence to support taking metformin to improve PC‐specific outcomes	12	86			2	14
The urologist should communicate with the PCP or endocrinologist when patients with diabetes initiate ADT as they may need closer monitoring of diabetes	12	86			2	14
HbA1c should be monitored up to annually by a cancer care provider or PCP in patients without a history of diabetes
Cancer‐treating physicians should encourage physical activity/exercise, healthy diet, weight control, and smoking cessation in all patients on ADT throughout the course of their treatment	14	100
We recognize the importance of increasing urologists’ awareness of depression risk in patients receiving ADT	14	100
Urologists need to be aware of depression risk in patients receiving ADT	14	100
Consider routine discussions of mental health concerns, including questions about depression and memory concerns, with evaluation performed at least annually, in men receiving ADT	14	100
Patients over the age of 70 who have been on ADT for >2 years should be referred annually for neurocognitive assessment to evaluate for dementia	4	29	3	21	7	50
We recognize hot flashes are side effects of ADT that can negatively impact patient quality of life. Of all the agents that are currently being used to treat hot flashes in men receiving ADT, none have an FDA approved indication for this use and each is associated with side effects. Shared decision‐making practices should be used to discuss the pros and cons of off‐label use of medications for hot flashes for men who wish to use medical management strategies	14	100

Abbreviations: ADT, androgen deprivation therapy; BCR, biochemical recurrence; CAB, combined androgen blockade; CT, computerized tomography; CVD, cardiovascular disease; DEXA, dexascan ‐ bone densitometry; HSPC, hormone sensitive metastatic prostate cancer; mCRPC, metastatic castrate‐resistant prostate cancer; mCSPC, metastatic castrate‐sensitive prostate cancer; mPC, metastatic PC; MRI, magnetic resonance imaging; NCCN, National Comprehensive Cancer Network; OS, overall survival; PC, prostate cancer; PCP, primary care provider; PSA, prostate‐specific antigen; PSADT, PSA doubling time; RP, radical prostatectomy.